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Phase 2 Study of the Monoclonal Antibody MGAH22 (Margetuximab) in Patients With Relapsed or Refractory Advanced Breast 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: NCT01828021
Recruitment Status : Completed
First Posted : April 10, 2013
Results First Posted : September 17, 2020
Last Update Posted : February 10, 2022
Sponsor:
Information provided by (Responsible Party):
MacroGenics

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Biological: Margetuximab
Enrollment 25
Recruitment Details Enrollment occurred at 6 US oncology centers -- 4 academic institutions and 2 clinical research centers, between May 2013 and November 2016.
Pre-assignment Details  
Arm/Group Title Margetuximab
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Monotherapy of Anti-HER2 monoclonal antibody

Margetuximab: Anti-HER2 monoclonal antibody

Margetuximab was administered by IV infusion at a dose of 6.0 mg/kg on Days 1, 8, and 15 of each 28-day cycle or or 15 mg/kg every 3 weeks of each 21-day cycle
Period Title: Overall Study
Started 25
Completed 0
Not Completed 25
Reason Not Completed
Adverse Event             5
Lack of Efficacy             17
Withdrawal by Subject             2
Ileal obstruction, unrelated             1
Arm/Group Title Margetuximab
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Monotherapy of Anti-HER2 monoclonal antibody

Margetuximab: Anti-HER2 monoclonal antibody
Overall Number of Baseline Participants 25
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All patients who received at least one dose of margetuximab
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
60.5  (10.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
25
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   8.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   8.0%
White
20
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
   4.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Performance Status 0
14
  56.0%
Performance Status 1
11
  44.0%
[1]
Measure Description: ECOG Performance Status assesses how the disease affects the daily living abilities of the patient and how the disease is progressing or improving. The scale ranges from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead); therefore, lower numbers indicate better status.
1.Primary Outcome
Title Best Overall Response
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Response based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria based on Cycle 2, Day 21 computed tomography (CT) scans. Response is categorized as complete response (CR): disappearance of all target lesions, confirmed at ≥ 4 weeks; partial response (PR): ≥ 30% decrease in target lesions from baseline, confirmed at ≥ 4 weeks; progressive disease (PD): ≥ 20% increase over smallest sum observed with an absolute increase of at least 5 mm, or appearance of new lesions; and stable disease (SD): neither PR or PD criteria met.

A Simon two-stage design was planned in which an initial cohort of 21 patients was treated. If 2 or more responses (PR or CR) are seen at the first tumor re-evaluation on day 21 of Cycle 2, the study would be expanded to include up to 41 patients (20 additional patients in Cohort 2, the second stage of the study) in order to determine whether further development of the drug is warranted (5 or more responses in 41 evaluable patients).
Time Frame Cycle 2, Day 21
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Hide Analysis Population Description
All patients with baseline tumor evaluation, received any amount of study drug, and had a tumor evaluation at Cycle 2 Day 21
Arm/Group Title Margetuximab
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Monotherapy of Anti-HER2 monoclonal antibody

Margetuximab: Anti-HER2 monoclonal antibody
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
Complete Response 0
Partial Response 0
Stable Disease 6
Progressive Disease 12
Not Done 4
2.Secondary Outcome
Title Response Rate
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Response rate is the proportion of patients achieving a best response of complete response or partial response when such responses are confirmed at least 28 days after initial observation of response.

Response based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria based on Cycle 2, Day 21 computed tomography (CT) scans. Response is categorized as complete response (CR): disappearance of all target lesions, confirmed at ≥ 4 weeks; partial response (PR): ≥ 30% decrease in target lesions from baseline, confirmed at ≥ 4 weeks; progressive disease (PD): ≥ 20% increase over smallest sum observed with an absolute increase of at least 5 mm, or appearance of new lesions; and stable disease (SD): neither PR or PD criteria met.
Time Frame Day 49
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Hide Analysis Population Description
All patients with baseline tumor measurement, at least one dose of study drug, and Cycle 2 Day 21 tumor assessment
Arm/Group Title Margetuximab
Hide Arm/Group Description:

Monotherapy of Anti-HER2 monoclonal antibody

Margetuximab: Anti-HER2 monoclonal antibody
Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame Adverse events were collected from time of consent until End of Study visit; average time on treatment was 35.6 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Margetuximab
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Monotherapy of Anti-HER2 monoclonal antibody

Margetuximab: Anti-HER2 monoclonal antibody
All-Cause Mortality
Margetuximab
Affected / at Risk (%)
Total   0/25 (0.00%) 
Hide Serious Adverse Events
Margetuximab
Affected / at Risk (%)
Total   6/25 (24.00%) 
Cardiac disorders   
Supraventricular extrasystoles † 1  1/25 (4.00%) 
Ventricular extrasystoles † 1  1/25 (4.00%) 
Gastrointestinal disorders   
Ascites † 1  2/25 (8.00%) 
Diarrhea † 1  1/25 (4.00%) 
Nausea † 1  1/25 (4.00%) 
Pancreatitis † 1  1/25 (4.00%) 
Small intestinal obstruction † 1  1/25 (4.00%) 
Vomiting † 1  1/25 (4.00%) 
Hepatobiliary disorders   
Bile duct obstruction † 1  1/25 (4.00%) 
Portal hypertension † 1  1/25 (4.00%) 
Investigations   
Alanine aminotransferase increased † 1  1/25 (4.00%) 
Aspartate aminotransferase increased † 1  1/25 (4.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastases to meninges † 1  1/25 (4.00%) 
Renal and urinary disorders   
Renal failure acute † 1  2/25 (8.00%) 
1
Term from vocabulary, MedRA 15.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Margetuximab
Affected / at Risk (%)
Total   24/25 (96.00%) 
Blood and lymphatic system disorders   
Anemia † 1  2/25 (8.00%) 
Gastrointestinal disorders   
Nausea † 1  9/25 (36.00%) 
Vomiting † 1  6/25 (24.00%) 
Diarrhea † 1  5/25 (20.00%) 
Abdominal pain † 1  3/25 (12.00%) 
Ascites † 1  2/25 (8.00%) 
General disorders   
Fatigue † 1  6/25 (24.00%) 
Chest pain † 1  2/25 (8.00%) 
Chills † 1  2/25 (8.00%) 
Injury, poisoning and procedural complications   
Infusion related reaction † 1  5/25 (20.00%) 
Procedural nausea † 1  2/25 (8.00%) 
Investigations   
Alanine aminotransferase increased † 1  2/25 (8.00%) 
Aspartate aminotransferase increased † 1  2/25 (8.00%) 
Blood alkaline phosphatase increased † 1  2/25 (8.00%) 
Ejection fraction decreased † 1  2/25 (8.00%) 
Lymphoctye count decreased † 1  2/25 (8.00%) 
Metabolism and nutrition disorders   
Decreased appetite † 1  3/25 (12.00%) 
Musculoskeletal and connective tissue disorders   
Back pain † 1  2/25 (8.00%) 
Nervous system disorders   
Headache † 1  4/25 (16.00%) 
Neuropathy periphera † 1  2/25 (8.00%) 
Psychiatric disorders   
Anxiety † 1  2/25 (8.00%) 
Depression † 1  2/25 (8.00%) 
Renal and urinary disorders   
Renal failure acute † 1  2/25 (8.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1  2/25 (8.00%) 
Dyspnea † 1  2/25 (8.00%) 
Vascular disorders   
Hypertension † 1  2/25 (8.00%) 
1
Term from vocabulary, MedRA 15.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: MacroGenics, Inc.
Phone: 301-251-5172
EMail: info@macrogenics.com
Publications:
Layout table for additonal information
Responsible Party: MacroGenics
ClinicalTrials.gov Identifier: NCT01828021    
Other Study ID Numbers: CP-MGAH22-02
First Submitted: March 26, 2013
First Posted: April 10, 2013
Results First Submitted: August 13, 2020
Results First Posted: September 17, 2020
Last Update Posted: February 10, 2022