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Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01631552
Recruitment Status : Completed
First Posted : June 29, 2012
Results First Posted : April 6, 2021
Last Update Posted : August 12, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Gastric Adenocarcinoma
Esophageal Cancer
Hepatocellular Carcinoma
Non-small Cell Lung Cancer
Small Cell Lung Cancer
Ovarian Epithelial Cancer
Carcinoma Breast Stage IV
Hormone-refractory Prostate Cancer
Head and Neck Cancers- Squamous Cell
Renal Cell Cancer
Urinary Bladder Neoplasms
Cervical Cancer
Endometrial Cancer
Glioblastoma Multiforme
Triple Negative Breast Cancer
Pancreatic Cancer
Intervention Drug: Sacituzumab Govitecan-hziy (SG)
Enrollment 515
Recruitment Details

Participants were enrolled at study sites in the United States. The first participant was screened on 17 December 2012. The last study visit occurred on 13 August 2020.

Outcome Measures were assessed up to the data cutoff date of 01 March 2019. Following the data cutoff date, the participants either stayed on the study and were followed for safety data collection or rolled into another Gilead-sponsored study. Therefore, only safety data was collected after the data cutoff date.
Pre-assignment Details Tumor types included in the study were as follows: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC).
Arm/Group Title Sacituzumab Govitecan-hziy (SG) 8 mg/kg SG 10 mg/kg SG 12 mg/kg SG 18 mg/kg
Hide Arm/Group Description Participants received sacituzumab govitecan-hziy (SG) 8 mg/kg of body weight via intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity. Participants received sacituzumab govitecan-hziy 10 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity. Participants received sacituzumab govitecan-hziy 12 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity. Participants received sacituzumab govitecan-hziy 18 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 83 420 9 3
Enrolled and Treated 81 402 9 3
Completed 81 400 9 3
Not Completed 2 20 0 0
Arm/Group Title SG 8mg/kg SG 10 mg/kg SG 12 mg/kg SG 18 mg/kg Total
Hide Arm/Group Description Participants received sacituzumab govitecan-hziy 8 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity. Participants received sacituzumab govitecan-hziy 10 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity. Participants received sacituzumab govitecan-hziy 12 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity. Participants received sacituzumab govitecan-hziy 18 mg/kg of body weight via IV infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 81 402 9 3 495
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 402 participants 9 participants 3 participants 495 participants
61.1  (10.91) 59.8  (11.28) 59.1  (10.53) 56.0  (4.00) 60.0  (11.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 402 participants 9 participants 3 participants 495 participants
Female
46
  56.8%
281
  69.9%
6
  66.7%
1
  33.3%
334
  67.5%
Male
35
  43.2%
121
  30.1%
3
  33.3%
2
  66.7%
161
  32.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 81 participants 402 participants 9 participants 3 participants 495 participants
White
67
  82.7%
329
  81.8%
6
  66.7%
3
 100.0%
405
  81.8%
Black
6
   7.4%
19
   4.7%
2
  22.2%
0
   0.0%
27
   5.5%
Asian
4
   4.9%
13
   3.2%
1
  11.1%
0
   0.0%
18
   3.6%
Other
4
   4.9%
41
  10.2%
0
   0.0%
0
   0.0%
45
   9.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 81 participants 402 participants 9 participants 3 participants 495 participants
Hispanic or Latino
4
   4.9%
16
   4.0%
0
   0.0%
0
   0.0%
20
   4.0%
Not Hispanic or Latino
77
  95.1%
386
  96.0%
9
 100.0%
3
 100.0%
475
  96.0%
1.Primary Outcome
Title Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events
Hide Description

Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious:

  • Fatal
  • Life-threatening
  • Disabling/incapacitating
  • Results in hospitalization or prolongs a hospital stay
  • A congenital abnormality
  • Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above

Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population.
Time Frame First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
  • Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease & who received at least 1 dose of 10 mg/kg SG
  • HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy & who received at least 1 dose of 10 mg/kg SG
  • mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments & who received at least 1 dose of 10 mg/kg SG
  • OSP: All participants who received at least 1 dose of SG
Arm/Group Title TNBC Target Population HR+/HER2- mBC Population mUC Population Overall Safety Population (OSP)
Hide Arm/Group Description:
Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as Hormone receptor-positive/Human epidermal growth factor receptor 2-negative (HR+/HER2-), had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
Overall 495 participants were enrolled in the study and received at least one dose of 10 mg/kg, 8 mg/kg, 12mg/kg, or 18mg/kg SG. These participants were included in the Overall Safety Population and analyzed for safety.
Overall Number of Participants Analyzed 108 54 45 495
Measure Type: Number
Unit of Measure: Percentage of participants
Adverse Events 100.0 100.0 100.0 99.8
Serious Adverse Events 30.6 35.2 42.2 38.8
2.Primary Outcome
Title Percentage of Participants Who Permanently Discontinued Sacituzumab Govitecan-hziy (SG) Due to Any Adverse Events, Excluding Adverse Events Leading to Death
Hide Description Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population (OSP).
Time Frame First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
  • Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease & who received at least 1 dose of 10 mg/kg SG
  • HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy & who received at least 1 dose of 10 mg/kg SG
  • mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments & who received at least 1 dose of 10 mg/kg SG
  • OSP: All participants who received at least 1 dose of SG
Arm/Group Title TNBC Target Population HR+/HER2- mBC Population mUC Population Overall Safety Population (OSP)
Hide Arm/Group Description:
Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
Overall 495 participants were enrolled in the study and received at least one dose of 10 mg/kg, 8 mg/kg, 12mg/kg, or 18mg/kg SG. These participants were included in the Overall Safety Population and analyzed for safety.
Overall Number of Participants Analyzed 108 54 45 495
Measure Type: Number
Unit of Measure: Percentage of participants
2.8 5.6 15.6 8.1
3.Primary Outcome
Title Percentage of Participants Who Required Dose Interruption Due to Any Adverse Events
Hide Description Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population (OSP).
Time Frame First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
  • Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease & who received at least 1 dose of 10 mg/kg SG
  • HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy & who received at least 1 dose of 10 mg/kg SG
  • mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments & who received at least 1 dose of 10 mg/kg SG
  • OSP: All participants who received at least 1 dose of SG
Arm/Group Title TNBC Target Population HR+/HER2- mBC Population mUC Population Overall Safety Population (OSP)
Hide Arm/Group Description:
Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
Overall 495 participants were enrolled in the study and received at least one dose of 10 mg/kg, 8 mg/kg, 12mg/kg, or 18mg/kg SG. These participants were included in the Overall Safety Population and analyzed for safety.
Overall Number of Participants Analyzed 108 54 45 495
Measure Type: Number
Unit of Measure: Percentage of participants
45.4 46.3 51.1 51.7
4.Primary Outcome
Title Objective Response Rate (ORR) by Independent Central Review (ICR)
Hide Description ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by ICR assessment according to RECIST1.1. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to <10 mm. PR was defined as ≥ 30% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only.
Time Frame Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease and who received SG at a dose of 10 mg/kg.
Arm/Group Title TNBC Target Population
Hide Arm/Group Description:
Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
34.3
(25.4 to 44.0)
5.Primary Outcome
Title Objective Response Rate by Local Assessment
Hide Description ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by local assessment. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to <10 mm. PR was defined as ≥3 0% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by Local Assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
Time Frame Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
Hide Outcome Measure Data
Hide Analysis Population Description
  • Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease & who received at least 1 dose of 10 mg/kg SG
  • HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy & who received at least 1 dose of 10 mg/kg SG
  • mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments & who received at least 1 dose of 10 mg/kg SG
Arm/Group Title TNBC Target Population HR+/HER2- mBC Population mUC Population
Hide Arm/Group Description:
Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
Overall Number of Participants Analyzed 108 54 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
33.3
(24.6 to 43.1)
31.5
(19.5 to 45.6)
28.9
(16.4 to 44.3)
6.Secondary Outcome
Title Duration of Response by ICR
Hide Description Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only.
Time Frame Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease and who received SG at a dose of 10 mg/kg. Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only.
Arm/Group Title TNBC Target Population
Hide Arm/Group Description:
Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
Overall Number of Participants Analyzed 108
Median (95% Confidence Interval)
Unit of Measure: months
9.1
(4.6 to 11.3)
7.Secondary Outcome
Title Duration of Response by Local Assessment
Hide Description Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Per planned analysis, duration of response by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
Time Frame Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
Hide Outcome Measure Data
Hide Analysis Population Description
  • Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease & who received at least 1 dose of 10 mg/kg SG
  • HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy & who received at least 1 dose of 10 mg/kg SG
  • mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments & who received at least 1 dose of 10 mg/kg SG
Arm/Group Title TNBC Target Population HR+/HER2- mBC Population mUC Population
Hide Arm/Group Description:
Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
Overall Number of Participants Analyzed 108 54 45
Median (95% Confidence Interval)
Unit of Measure: months
7.7
(4.9 to 10.8)
8.7
(3.7 to 12.7)
12.9
(3.8 to 22.5)
8.Secondary Outcome
Title Time to Response by ICR
Hide Description Time to response was defined as the time from the first dose to the first documentation of response (PR or CR). Per planned analysis, time to response by ICR was assessed for the TNBC Target Population only.
Time Frame Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease & who received at least 1 dose of 10 mg/kg SG
Arm/Group Title TNBC Target Population
Hide Arm/Group Description:
Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
Overall Number of Participants Analyzed 108
Median (Full Range)
Unit of Measure: months
2.2
(1.6 to 7.6)
9.Secondary Outcome
Title Time to Response by Local Assessments
Hide Description Time to response was defined as the time from the first dose to the first documentation of response (PR or CR). Per planned analysis, time to response by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
Time Frame Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
Hide Outcome Measure Data
Hide Analysis Population Description
  • Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease & who received at least 1 dose of 10 mg/kg SG
  • HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy & who received at least 1 dose of 10 mg/kg SG
  • mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments & who received at least 1 dose of 10 mg/kg SG
Arm/Group Title TNBC Target Population (TNBC Population) HR+/HER2- mBC Population (Non-TNBC) mUC Population
Hide Arm/Group Description:
Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
Overall Number of Participants Analyzed 108 54 45
Median (Full Range)
Unit of Measure: months
2.0
(1.6 to 13.5)
2.1
(1.4 to 7.8)
1.9
(1.7 to 7.4)
10.Secondary Outcome
Title Clinical Benefit Rate (CBR) by Local Assessment
Hide Description Clinical benefit rate (CR+PR+[stable disease (SD) ≥ 6 months]) is defined as those participants with best response as CR or PR or else SD with a duration of at least 6 months. SD for 6 months duration was defined as the time from the first dose to the first documentation of PD or to the last adequate response assessment prior to data cut-off date, whichever is earlier. Per planned analysis, CBR by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
Time Frame Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
Hide Outcome Measure Data
Hide Analysis Population Description
  • Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease & who received at least 1 dose of 10 mg/kg SG
  • HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy & who received at least 1 dose of 10 mg/kg SG
  • mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments & who received at least 1 dose of 10 mg/kg SG
Arm/Group Title TNBC Target Population HR+/HER2- mBC Population mUC Population
Hide Arm/Group Description:
Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
Overall Number of Participants Analyzed 108 54 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
45.4
(35.8 to 55.2)
44.4
(30.9 to 58.6)
44.4
(29.6 to 60.0)
11.Secondary Outcome
Title Progression Free Survival (PFS) by Local Assessment
Hide Description Progression-free survival (PFS) was defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first. Per planned analysis, PFS by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
Time Frame Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
Hide Outcome Measure Data
Hide Analysis Population Description
  • Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease & who received at least 1 dose of 10 mg/kg SG
  • HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy & who received at least 1 dose of 10 mg/kg SG
  • mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments & who received at least 1 dose of 10 mg/kg SG
Arm/Group Title TNBC Target Population HR+/HER2- mBC Population mUC Population
Hide Arm/Group Description:
Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
Overall Number of Participants Analyzed 108 54 45
Median (95% Confidence Interval)
Unit of Measure: months
5.6
(4.8 to 6.6)
5.5
(3.6 to 7.6)
6.8
(3.6 to 9.7)
12.Secondary Outcome
Title Overall Survival by Local Assessment
Hide Description Overall survival was defined as the time from the date of the first dose start date to the date of death due to any cause. Per planned analysis, overall survival by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
Time Frame Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
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Hide Analysis Population Description
  • Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease & who received at least 1 dose of 10 mg/kg SG
  • HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy & who received at least 1 dose of 10 mg/kg SG
  • mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments & who received at least 1 dose of 10 mg/kg SG
Arm/Group Title TNBC Target Population HR+/HER2- mBC Population mUC Population
Hide Arm/Group Description:
Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
Overall, 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
Overall Number of Participants Analyzed 108 54 45
Median (95% Confidence Interval)
Unit of Measure: months
13.0
(11.2 to 14.0)
12.0
(9.0 to 18.2)
16.8
(9.0 to 21.9)
13.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: T1/2 of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38
Hide Description T1/2 was determined for 5 analytes: total antibody, SN-38 glucuronide, total SN-38, free SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration. SN-38 is one of the components of sacituzumab govitecan-hziy. T1/2 is defined as apparent terminal elimination half-life (h); calculated as 0.693/λz. The dose level evaluated for PK analysis was 10 mg/kg.
Time Frame Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hours (± 30 minutes) for subsequent infusions
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Hide Analysis Population Description
Participants with epithelial cancer that involved any one of the following with available data were analyzed: cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head & neck cancers- squamous cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non TNBC, TNBC and mUC.
Arm/Group Title SG 10 mg/kg
Hide Arm/Group Description:

Participants included adults with the following tumor types:

cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non-triple-negative breast cancer, triple-negative breast cancer, and metastatic urothelial cancer.

All participants received SG 10 mg/kg of body weight by IV infusion on Days 1 and 8 of a 21-day treatment cycle.
Overall Number of Participants Analyzed 128
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
Total Antibody Number Analyzed 5 participants
66.6
(14.4%)
SN-38G Number Analyzed 63 participants
21.4
(24.5%)
Total SN-38 Number Analyzed 128 participants
20.2
(26.6%)
Sacituzumab Govitecan-hziy (SG) Number Analyzed 120 participants
15.0
(15.3%)
Free SN-38 Number Analyzed 95 participants
17.1
(18.6%)
14.Secondary Outcome
Title PK Parameter: AUC0-24 of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38
Hide Description AUC0-24 was determined for 5 analytes: total antibody, SN-38 glucuronide, total SN-38, free SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration. SN-38 is one of the components of sacituzumab govitecan-hziy. AUC0-24 is defined as area under the serum concentration-time curve from time 0 to 24 hours. The dose level evaluated for PK analysis was 10 mg/kg.
Time Frame Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hour (± 30 minutes) for subsequent infusions
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Hide Analysis Population Description
Participants with epithelial cancer that involved any one of the following with available data were analyzed: cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head & neck cancers- squamouse cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non TNBC, TNBC and mUC.
Arm/Group Title SG 10 mg/kg
Hide Arm/Group Description:

Participants included adults with the following tumor types:

cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non-triple-negative breast cancer, triple-negative breast cancer, and metastatic urothelial cancer.

All participants received SG 10 mg/kg of body weight by IV infusion on Days 1 and 8 of a 21-day treatment cycle.
Overall Number of Participants Analyzed 128
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram*hour per liter
Total Antibody Number Analyzed 5 participants
4940
(30.1%)
SN-38G Number Analyzed 63 participants
0.370
(45.6%)
Total SN-38 Number Analyzed 128 participants
65.5
(29.2%)
Sacituzumab Govitecan-hziy (SG) Number Analyzed 120 participants
3290
(25.2%)
Free SN-38 Number Analyzed 95 participants
1.67
(58.5%)
15.Secondary Outcome
Title PK Parameter: AUC0-168 of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38
Hide Description AUC0-168 was determined for 5 analytes: total antibody, SN-38 glucuronide, total SN-38, free SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration. SN-38 is one of the components of sacituzumab govitecan-hziy. AUC0-168 is defined as area under the serum concentration-time curve from time 0 to 168 hours. The dose level evaluated for PK analysis was 10 mg/kg.
Time Frame Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hour (± 30 minutes) for subsequent infusions
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with epithelial cancer that involved any one of the following with available data were analyzed: cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head & neck cancers- squamouse cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non TNBC, TNBC and mUC.
Arm/Group Title SG 10 mg/kg
Hide Arm/Group Description:

Participants included adults with the following tumor types:

cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non-triple-negative breast cancer, triple-negative breast cancer, and metastatic urothelial cancer.

All participants received SG 10 mg/kg of body weight by IV infusion on Days 1 and 8 of a 21-day treatment cycle.
Overall Number of Participants Analyzed 128
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram*hour per liter
Total Antibody Number Analyzed 5 participants
20800
(22.2%)
SN-38G Number Analyzed 63 participants
0.842
(50.0%)
Total SN-38 Number Analyzed 128 participants
107
(25.4%)
Sacituzumab Govitecan-hziy (SG) Number Analyzed 120 participants
5050
(24.4%)
Free SN-38 Number Analyzed 95 participants
3.08
(56.6%)
16.Secondary Outcome
Title PK Parameter: AUC0-inf of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38
Hide Description AUC0-inf was determined for 5 analytes: total antibody, SN-38 glucuronide, total SN-38, free SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration. SN-38 is one of the components of sacituzumab govitecan-hziy. AUC0-inf is defined as area under the serum concentration-time curve from time 0 extrapolated to infinity. The dose level evaluated for PK analysis was 10 mg/kg.
Time Frame Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hour (± 30 minutes) for subsequent infusions
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with epithelial cancer that involved any one of the following with available data were analyzed: cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head & neck cancers- squamouse cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non TNBC, TNBC and mUC.
Arm/Group Title SG 10 mg/kg
Hide Arm/Group Description:

Participants included adults with the following tumor types:

cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non-triple-negative breast cancer, triple-negative breast cancer, and metastatic urothelial cancer.

All participants received SG 10 mg/kg of body weight by IV infusion on Days 1 and 8 of a 21-day treatment cycle.
Overall Number of Participants Analyzed 128
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram*hour per liter
Total Antibody Number Analyzed 5 participants
25100
(20.5%)
SN-38G Number Analyzed 63 participants
0.850
(50.7%)
Total SN-38 Number Analyzed 128 participants
107
(25.5%)
Sacituzumab Govitecan-hziy (SG) Number Analyzed 120 participants
5050
(24.4%)
Free SN-38 Number Analyzed 95 participants
3.08
(56.6%)
17.Secondary Outcome
Title PK Parameter: Cmax of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38
Hide Description Cmax was determined for 5 analytes: total antibody, SN-38 glucuronide, total SN-38, free SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration. SN-38 is one of the components of sacituzumab govitecan-hziy. Cmax is defined as maximum observed serum concentration obtained directly from the observed concentration-time data. The dose level evaluated for PK analysis was 10 mg/kg.
Time Frame Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hour (± 30 minutes) for subsequent infusions
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with epithelial cancer that involved any one of the following with available data were analyzed: cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head & neck cancers- squamouse cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non TNBC, TNBC and mUC.
Arm/Group Title SG 10 mg/kg
Hide Arm/Group Description:

Participants included adults with the following tumor types:

cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non-triple-negative breast cancer, triple-negative breast cancer, and metastatic urothelial cancer.

All participants received SG 10 mg/kg of body weight by IV infusion on Days 1 and 8 of a 21-day treatment cycle.
Overall Number of Participants Analyzed 128
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram per liter
Total Antibody Number Analyzed 5 participants
245
(26.9%)
SN-38G Number Analyzed 63 participants
0.0206
(50.4%)
Total SN-38 Number Analyzed 128 participants
4.39
(25.2%)
Sacituzumab Govitecan-hziy (SG) Number Analyzed 120 participants
220
(24.7%)
Free SN-38 Number Analyzed 95 participants
0.0992
(61.1%)
Time Frame - Adverse Events: First dose date up to 91.88 months plus 30 days - All-Cause Mortality: First dose date up to 91.88 months
Adverse Event Reporting Description Overall Safety Population: All participants who received at least 1 dose of SG. Per planned analysis, data were collected for the Overall Safety Population, pooling all participants regardless of dose level received.
 
Arm/Group Title Overall Safety Population
Hide Arm/Group Description All participants who were enrolled in the study and received one dose of sacituzumab govitecan-hziy (SG) at dose level of either 8 mg/kg, 10 mg/kg, 12 mg/kg, or 18 mg/kg of body weight via intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.
All-Cause Mortality
Overall Safety Population
Affected / at Risk (%)
Total   422/495 (85.25%) 
Hide Serious Adverse Events
Overall Safety Population
Affected / at Risk (%)
Total   192/495 (38.79%) 
Blood and lymphatic system disorders   
Anaemia † 1  4/495 (0.81%) 
Febrile neutropenia † 1  20/495 (4.04%) 
Leukocytosis † 1  1/495 (0.20%) 
Leukopenia † 1  1/495 (0.20%) 
Lymphopenia † 1  1/495 (0.20%) 
Neutropenia † 1  7/495 (1.41%) 
Cardiac disorders   
Acute myocardial infarction † 1  1/495 (0.20%) 
Atrial fibrillation † 1  3/495 (0.61%) 
Cardiac tamponade † 1  1/495 (0.20%) 
Cardio-respiratory arrest † 1  1/495 (0.20%) 
Myocardial infarction † 1  2/495 (0.40%) 
Endocrine disorders   
Inappropriate antidiuretic hormone secretion † 1  1/495 (0.20%) 
Eye disorders   
Purtscher retinopathy † 1  1/495 (0.20%) 
Gastrointestinal disorders   
Abdominal pain † 1  6/495 (1.21%) 
Abdominal pain upper † 1  1/495 (0.20%) 
Colitis † 1  3/495 (0.61%) 
Constipation † 1  1/495 (0.20%) 
Diarrhoea † 1  18/495 (3.64%) 
Dysphagia † 1  2/495 (0.40%) 
Gastrointestinal haemorrhage † 1  1/495 (0.20%) 
Intestinal obstruction † 1  2/495 (0.40%) 
Lower gastrointestinal haemorrhage † 1  1/495 (0.20%) 
Nausea † 1  10/495 (2.02%) 
Neutropenic colitis † 1  2/495 (0.40%) 
Oesophageal obstruction † 1  1/495 (0.20%) 
Oesophagitis † 1  1/495 (0.20%) 
Pouchitis † 1  1/495 (0.20%) 
Proctalgia † 1  1/495 (0.20%) 
Small intestinal obstruction † 1  7/495 (1.41%) 
Upper gastrointestinal haemorrhage † 1  1/495 (0.20%) 
Vomiting † 1  11/495 (2.22%) 
General disorders   
Asthenia † 1  3/495 (0.61%) 
Chest pain † 1  4/495 (0.81%) 
Face oedema † 1  1/495 (0.20%) 
Fatigue † 1  4/495 (0.81%) 
Gait disturbance † 1  1/495 (0.20%) 
Generalised oedema † 1  2/495 (0.40%) 
Localised oedema † 1  2/495 (0.40%) 
Non-cardiac chest pain † 1  1/495 (0.20%) 
Oedema peripheral † 1  2/495 (0.40%) 
Pain † 1  5/495 (1.01%) 
Pyrexia † 1  4/495 (0.81%) 
Systemic inflammatory response syndrome † 1  1/495 (0.20%) 
Hepatobiliary disorders   
Bile duct stenosis † 1  1/495 (0.20%) 
Bile duct stone † 1  1/495 (0.20%) 
Cholecystitis † 1  1/495 (0.20%) 
Hyperbilirubinaemia † 1  2/495 (0.40%) 
Immune system disorders   
Anaphylactic reaction † 1  1/495 (0.20%) 
Infections and infestations   
Clostridium difficile colitis † 1  2/495 (0.40%) 
Clostridium difficile infection † 1  1/495 (0.20%) 
Covid-19 pneumonia † 1  1/495 (0.20%) 
Diverticulitis † 1  1/495 (0.20%) 
Enterocolitis infectious † 1  1/495 (0.20%) 
Epiglottitis † 1  1/495 (0.20%) 
Escherichia infection † 1  1/495 (0.20%) 
Escherichia urinary tract infection † 1  1/495 (0.20%) 
Herpes zoster † 1  1/495 (0.20%) 
Influenza † 1  1/495 (0.20%) 
Liver abscess † 1  1/495 (0.20%) 
Peritonitis † 1  1/495 (0.20%) 
Pleural infection † 1  1/495 (0.20%) 
Pneumonia † 1  14/495 (2.83%) 
Pyelonephritis † 1  1/495 (0.20%) 
Rectal abscess † 1  1/495 (0.20%) 
Respiratory syncytial virus infection † 1  1/495 (0.20%) 
Sepsis † 1  3/495 (0.61%) 
Septic shock † 1  1/495 (0.20%) 
Staphylococcal bacteraemia † 1  1/495 (0.20%) 
Upper respiratory tract infection † 1  1/495 (0.20%) 
Urinary tract infection † 1  3/495 (0.61%) 
Vascular device infection † 1  1/495 (0.20%) 
Injury, poisoning and procedural complications   
Fall † 1  1/495 (0.20%) 
Femur fracture † 1  1/495 (0.20%) 
Humerus fracture † 1  1/495 (0.20%) 
Lower limb fracture † 1  1/495 (0.20%) 
Post procedural fever † 1  1/495 (0.20%) 
Post procedural haemorrhage † 1  1/495 (0.20%) 
Radiation pneumonitis † 1  1/495 (0.20%) 
Spinal compression fracture † 1  1/495 (0.20%) 
Investigations   
Neutrophil count decreased † 1  3/495 (0.61%) 
Metabolism and nutrition disorders   
Dehydration † 1  4/495 (0.81%) 
Failure to thrive † 1  2/495 (0.40%) 
Hypernatraemia † 1  1/495 (0.20%) 
Hypokalaemia † 1  1/495 (0.20%) 
Hyponatraemia † 1  1/495 (0.20%) 
Malnutrition † 1  1/495 (0.20%) 
Musculoskeletal and connective tissue disorders   
Arthralgia † 1  1/495 (0.20%) 
Back pain † 1  2/495 (0.40%) 
Muscular weakness † 1  2/495 (0.40%) 
Musculoskeletal pain † 1  1/495 (0.20%) 
Pain in extremity † 1  1/495 (0.20%) 
Pathological fracture † 1  1/495 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenocarcinoma † 1  1/495 (0.20%) 
Metastases to central nervous system † 1  1/495 (0.20%) 
Metastases to spine † 1  1/495 (0.20%) 
Squamous cell carcinoma of skin † 1  1/495 (0.20%) 
Nervous system disorders   
Cerebrovascular accident † 1  1/495 (0.20%) 
Dizziness † 1  1/495 (0.20%) 
Hypoaesthesia † 1  1/495 (0.20%) 
Spinal cord compression † 1  1/495 (0.20%) 
Syncope † 1  3/495 (0.61%) 
Vocal cord paralysis † 1  1/495 (0.20%) 
Psychiatric disorders   
Confusional state † 1  2/495 (0.40%) 
Delirium † 1  1/495 (0.20%) 
Depression † 1  1/495 (0.20%) 
Mental status changes † 1  4/495 (0.81%) 
Renal and urinary disorders   
Acute kidney injury † 1  2/495 (0.40%) 
Renal failure † 1  1/495 (0.20%) 
Urinary retention † 1  2/495 (0.40%) 
Urinary tract obstruction † 1  1/495 (0.20%) 
Reproductive system and breast disorders   
Vaginal haemorrhage † 1  1/495 (0.20%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure † 1  1/495 (0.20%) 
Aspiration † 1  1/495 (0.20%) 
Bronchial obstruction † 1  1/495 (0.20%) 
Chronic obstructive pulmonary disease † 1  1/495 (0.20%) 
Dyspnoea † 1  12/495 (2.42%) 
Dyspnoea exertional † 1  1/495 (0.20%) 
Epistaxis † 1  1/495 (0.20%) 
Haemoptysis † 1  1/495 (0.20%) 
Hiccups † 1  1/495 (0.20%) 
Hypoxia † 1  3/495 (0.61%) 
Pleural effusion † 1  7/495 (1.41%) 
Pneumonia aspiration † 1  1/495 (0.20%) 
Pulmonary embolism † 1  4/495 (0.81%) 
Respiratory distress † 1  1/495 (0.20%) 
Respiratory failure † 1  4/495 (0.81%) 
Vocal cord dysfunction † 1  1/495 (0.20%) 
Skin and subcutaneous tissue disorders   
Paraneoplastic dermatomyositis † 1  1/495 (0.20%) 
Vascular disorders   
Deep vein thrombosis † 1  2/495 (0.40%) 
Embolism † 1  2/495 (0.40%) 
Hypertension † 1  2/495 (0.40%) 
Hypotension † 1  1/495 (0.20%) 
Peripheral embolism † 1  1/495 (0.20%) 
1
Term from vocabulary, MedDRA 24.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Overall Safety Population
Affected / at Risk (%)
Total   490/495 (98.99%) 
Blood and lymphatic system disorders   
Anaemia † 1  207/495 (41.82%) 
Neutropenia † 1  196/495 (39.60%) 
Gastrointestinal disorders   
Abdominal distension † 1  25/495 (5.05%) 
Abdominal pain † 1  108/495 (21.82%) 
Constipation † 1  184/495 (37.17%) 
Diarrhoea † 1  303/495 (61.21%) 
Dyspepsia † 1  26/495 (5.25%) 
Gastrooesophageal reflux disease † 1  25/495 (5.05%) 
Nausea † 1  342/495 (69.09%) 
Stomatitis † 1  27/495 (5.45%) 
Vomiting † 1  220/495 (44.44%) 
General disorders   
Asthenia † 1  27/495 (5.45%) 
Chest pain † 1  33/495 (6.67%) 
Chills † 1  33/495 (6.67%) 
Fatigue † 1  280/495 (56.57%) 
Oedema peripheral † 1  79/495 (15.96%) 
Pain † 1  27/495 (5.45%) 
Pyrexia † 1  80/495 (16.16%) 
Infections and infestations   
Upper respiratory tract infection † 1  60/495 (12.12%) 
Urinary tract infection † 1  65/495 (13.13%) 
Investigations   
Activated partial thromboplastin time prolonged † 1  33/495 (6.67%) 
Alanine aminotransferase increased † 1  44/495 (8.89%) 
Aspartate aminotransferase increased † 1  47/495 (9.49%) 
Blood alkaline phosphatase increased † 1  55/495 (11.11%) 
Lymphocyte count decreased † 1  38/495 (7.68%) 
Neutrophil count decreased † 1  98/495 (19.80%) 
Weight decreased † 1  75/495 (15.15%) 
White blood cell count decreased † 1  77/495 (15.56%) 
Metabolism and nutrition disorders   
Decreased appetite † 1  171/495 (34.55%) 
Dehydration † 1  78/495 (15.76%) 
Hyperglycaemia † 1  54/495 (10.91%) 
Hypoalbuminaemia † 1  30/495 (6.06%) 
Hypocalcaemia † 1  26/495 (5.25%) 
Hypokalaemia † 1  89/495 (17.98%) 
Hypomagnesaemia † 1  89/495 (17.98%) 
Hyponatraemia † 1  38/495 (7.68%) 
Hypophosphataemia † 1  65/495 (13.13%) 
Musculoskeletal and connective tissue disorders   
Arthralgia † 1  68/495 (13.74%) 
Back pain † 1  75/495 (15.15%) 
Muscular weakness † 1  31/495 (6.26%) 
Myalgia † 1  28/495 (5.66%) 
Pain in extremity † 1  45/495 (9.09%) 
Nervous system disorders   
Dizziness † 1  81/495 (16.36%) 
Dysgeusia † 1  33/495 (6.67%) 
Headache † 1  78/495 (15.76%) 
Neuropathy peripheral † 1  30/495 (6.06%) 
Psychiatric disorders   
Anxiety † 1  30/495 (6.06%) 
Depression † 1  29/495 (5.86%) 
Insomnia † 1  57/495 (11.52%) 
Renal and urinary disorders   
Haematuria † 1  25/495 (5.05%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1  101/495 (20.40%) 
Dyspnoea † 1  100/495 (20.20%) 
Epistaxis † 1  32/495 (6.46%) 
Nasal congestion † 1  29/495 (5.86%) 
Rhinorrhoea † 1  40/495 (8.08%) 
Skin and subcutaneous tissue disorders   
Alopecia † 1  216/495 (43.64%) 
Dry skin † 1  38/495 (7.68%) 
Pruritus † 1  62/495 (12.53%) 
Rash † 1  78/495 (15.76%) 
Vascular disorders   
Hypotension † 1  27/495 (5.45%) 
1
Term from vocabulary, MedDRA 24.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Immunomedics, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Immunomedics in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Publications of Results:
Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O'Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldenberg DM, Sharkey RM, Maliakal P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020 Dec;31(12):1709-1718. doi: 10.1016/j.annonc.2020.09.004. Epub 2020 Sep 15.
Santin AD, Komiya T, Goldenberg DM, et al. Sacituzumab govitecan (SG) in patients (pts) with previously treated metastatic endometrial cancer (mEC): results from a phase 1/2 study. J Clin Oncol. 2020; 38 (suppl; abstr 6081)
Bardia A, Mayer IA, Kalinsky K. Sacituzumab Govitecan-hziy in Triple-Negative Breast Cancer. Reply. N Engl J Med. 2019 Jun 13;380(24):2382. doi: 10.1056/NEJMc1903943. No abstract available.
Bardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR, O'Shaughnessy J, Moroose RL, Santin AD, Abramson VG, Shah NC, Rugo HS, Goldenberg DM, Sweidan AM, Iannone R, Washkowitz S, Sharkey RM, Wegener WA, Kalinsky K. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2019 Feb 21;380(8):741-751. doi: 10.1056/NEJMoa1814213.
Tagawa ST, Faltas M, Lam ET, et al. Sacituzumab govitecan (IMMU-132) in patients with previously treated metastatic urothelial cancer (mUC): Results from a phase I/II study. J Clin Oncol. 2019;39(suppl 7S):abstr 354.
Bardia A, Diamond JR, Vahdat LT, et al. Efficacy of sacituzumab govitecan (anti-Trop-2-SN-38 antibody-drug conjugate) for treatment-refractory hormone-receptor positive (HR+)/HER2- metastatic breast cancer (mBC). J Clin Oncol. 2018;36(15 suppl):1004.
Gray JE, Heist RS, Starodub AN, Camidge DR, Kio EA, Masters GA, Purcell WT, Guarino MJ, Misleh J, Schneider CJ, Schneider BJ, Ocean A, Johnson T, Gandhi L, Kalinsky K, Scheff R, Messersmith WA, Govindan SV, Maliakal PP, Mudenda B, Wegener WA, Sharkey RM, Goldenberg DM. Therapy of Small Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan. Clin Cancer Res. 2017 Oct 1;23(19):5711-5719. doi: 10.1158/1078-0432.CCR-17-0933. Epub 2017 Jul 5.
Ocean AJ, Starodub AN, Bardia A, Vahdat LT, Isakoff SJ, Guarino M, Messersmith WA, Picozzi VJ, Mayer IA, Wegener WA, Maliakal P, Govindan SV, Sharkey RM, Goldenberg DM. Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: Safety and pharmacokinetics. Cancer. 2017 Oct 1;123(19):3843-3854. doi: 10.1002/cncr.30789. Epub 2017 May 30.
Heist RS, Guarino MJ, Masters G, Purcell WT, Starodub AN, Horn L, Scheff RJ, Bardia A, Messersmith WA, Berlin J, Ocean AJ, Govindan SV, Maliakal P, Mudenda B, Wegener WA, Sharkey RM, Goldenberg DM, Camidge DR. Therapy of Advanced Non-Small-Cell Lung Cancer With an SN-38-Anti-Trop-2 Drug Conjugate, Sacituzumab Govitecan. J Clin Oncol. 2017 Aug 20;35(24):2790-2797. doi: 10.1200/JCO.2016.72.1894. Epub 2017 May 26.
Bardia A, Mayer IA, Diamond JR, Moroose RL, Isakoff SJ, Starodub AN, Shah NC, O'Shaughnessy J, Kalinsky K, Guarino M, Abramson V, Juric D, Tolaney SM, Berlin J, Messersmith WA, Ocean AJ, Wegener WA, Maliakal P, Sharkey RM, Govindan SV, Goldenberg DM, Vahdat LT. Efficacy and Safety of Anti-Trop-2 Antibody Drug Conjugate Sacituzumab Govitecan (IMMU-132) in Heavily Pretreated Patients With Metastatic Triple-Negative Breast Cancer. J Clin Oncol. 2017 Jul 1;35(19):2141-2148. doi: 10.1200/JCO.2016.70.8297. Epub 2017 Mar 14.
Sharkey RM, McBride WJ, Cardillo TM, Govindan SV, Wang Y, Rossi EA, Chang CH, Goldenberg DM. Enhanced Delivery of SN-38 to Human Tumor Xenografts with an Anti-Trop-2-SN-38 Antibody Conjugate (Sacituzumab Govitecan). Clin Cancer Res. 2015 Nov 15;21(22):5131-8. doi: 10.1158/1078-0432.CCR-15-0670. Epub 2015 Jun 23.
Starodub AN, Ocean AJ, Shah MA, Guarino MJ, Picozzi VJ Jr, Vahdat LT, Thomas SS, Govindan SV, Maliakal PP, Wegener WA, Hamburger SA, Sharkey RM, Goldenberg DM. First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. Clin Cancer Res. 2015 Sep 1;21(17):3870-8. doi: 10.1158/1078-0432.CCR-14-3321. Epub 2015 May 5.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01631552    
Other Study ID Numbers: IMMU-132-01
First Submitted: June 26, 2012
First Posted: June 29, 2012
Results First Submitted: February 9, 2021
Results First Posted: April 6, 2021
Last Update Posted: August 12, 2021