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A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors (DPT02)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04482309
Recruitment Status : Recruiting
First Posted : July 22, 2020
Last Update Posted : May 22, 2024
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE July 20, 2020
First Posted Date  ICMJE July 22, 2020
Last Update Posted Date May 22, 2024
Actual Study Start Date  ICMJE August 18, 2020
Estimated Primary Completion Date July 30, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2024)
Objective Response Rate (ORR) [ Time Frame: An average of approximately 6 months ]
Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2020)
Objective Response Rate (ORR) [ Time Frame: An average of approximately 12 months ]
Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2024)
  • Duration of response (DoR) [ Time Frame: An average of approximately 6 months ]
    DOR is defined as the time from the date of first documented response until the date of documented progression or death.
  • Disease control rate (DCR) [ Time Frame: An average of approximately 6 months ]
    DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD).
  • Progression free survival (PFS) [ Time Frame: An average of approximately 6 months ]
    PFS is the time from date of first dose of study treatment until the date of objective disease progression or death.
  • Proportion of patients alive and progression-free at 6 months and 12 months [ Time Frame: Up to 12 months ]
    The proportion of patients alive and progression-free at 6 and 12 months (Kaplan-Meier estimates).
  • Overall survival (OS) [ Time Frame: An average of approximately 14 months ]
    OS is the time from date of first dose of study treatment until death due to any cause.
  • Proportion of patients alive at 6 and 12 months [ Time Frame: Up to 12 months ]
    The proportion of patients alive at 6 and 12 months (Kaplan-Meier estimates).
  • Occurrence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: An average of approximately 8 months ]
    Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0.
  • Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181 [ Time Frame: An average of approximately 8 months ]
    Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd, total anti-HER2 antibody and MAAA-1181a
  • The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd [ Time Frame: An average of approximately 6 months ]
    Individual participant data and descriptive statistics will be provided for data at each time point.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2020)
  • Duration of response (DoR) [ Time Frame: An average of approximately 18 months ]
    DOR is defined as the time from the date of first documented response until the date of documented progression or death.
  • Disease control rate (DCR) [ Time Frame: An average of approximately 18 months ]
    DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD).
  • Progression free survival (PFS) [ Time Frame: An average of approximately 18 months ]
    PFS is the time from date of first dose of study treatment until the date of objective disease progression or death.
  • Proportion of patients alive and progression-free at 6 months and 12 months [ Time Frame: Up to 12 months ]
    The proportion of patients alive and progression-free at 6 and 12 months (Kaplan-Meier estimates).
  • Overall survival (OS) [ Time Frame: An average of approximately 30 months ]
    OS is the time from date of first dose of study treatment until death due to any cause.
  • Proportion of patients alive at 6 and 12 months [ Time Frame: Up to 12 months ]
    The proportion of patients alive at 6 and 12 months (Kaplan-Meier estimates).
  • Occurrence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: An average of approximately 24 months ]
    Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0.
  • Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181 [ Time Frame: An average of approximately 24 months ]
    Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd, total anti-HER2 antibody and MAAA-1181a
  • The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd [ Time Frame: An average of approximately 24 months ]
    Individual participant data and descriptive statistics will be provided for data at each time point.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Official Title  ICMJE A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)
Brief Summary

This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.

This study will consist of Part 1 which includes 7 cohorts of: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors; and Part 2 which includes 5 cohorts A to E of: A) any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer), B) any tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer), C) HER2 IHC 2+ or 1+ endometrial cancer, D) HER2 IHC 2+ or 1+ ovarian cancer, and E) HER2 IHC 2+ or 1+ cervical cancer.

Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study will consist of Part 1 which includes 7 cohorts of: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors; and Part 2 which includes 5 cohorts A to E of: A) any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer), B) any tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer), C) HER2 IHC 2+ or 1+ endometrial cancer, D) HER2 IHC 2+ or 1+ ovarian cancer, and E) HER2 IHC 2+ or 1+ cervical cancer.
Masking: None (Open Label)
Masking Description:
This study is Open-Label Study.
Primary Purpose: Treatment
Condition  ICMJE
  • Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer
  • Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
Intervention  ICMJE Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Other Names:
  • DS-8201a
  • T-DXd
Study Arms  ICMJE
  • Experimental: Part 1 Cohort 1
    Biliary tract cancer
    Intervention: Drug: Trastuzumab deruxtecan
  • Experimental: Part 1 Cohort 2
    Bladder cancer
    Intervention: Drug: Trastuzumab deruxtecan
  • Experimental: Part 1 Cohort 3
    Cervical cancer
    Intervention: Drug: Trastuzumab deruxtecan
  • Experimental: Part 1 Cohort 4
    Endometrial cancer
    Intervention: Drug: Trastuzumab deruxtecan
  • Experimental: Part 1 Cohort 5
    Ovarian cancer
    Intervention: Drug: Trastuzumab deruxtecan
  • Experimental: Part 1 Cohort 6
    Pancreatic cancer
    Intervention: Drug: Trastuzumab deruxtecan
  • Experimental: Part 1 Cohort 7
    Rare tumors
    Intervention: Drug: Trastuzumab deruxtecan
  • Experimental: Part 2 Cohort A
    Any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer)
    Intervention: Drug: Trastuzumab deruxtecan
  • Experimental: Part 2 Cohort B
    Any tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer)
    Intervention: Drug: Trastuzumab deruxtecan
  • Experimental: Part 2 Cohort C
    HER2 IHC 2+ or 1+ endometrial cancer
    Intervention: Drug: Trastuzumab deruxtecan
  • Experimental: Part 2 Cohort D
    HER2 IHC 2+ or 1+ ovarian cancer
    Intervention: Drug: Trastuzumab deruxtecan
  • Experimental: Part 2 Cohort E
    HER2 IHC 2+ or 1+ cervical cancer
    Intervention: Drug: Trastuzumab deruxtecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 7, 2023)
468
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2020)
280
Estimated Study Completion Date  ICMJE July 30, 2027
Estimated Primary Completion Date July 30, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Locally advanced, unresectable, or metastatic disease based on most recent imaging.
  • Part 1:The respective cohorts for patient inclusion are:

    • Cohort 1: Biliary tract cancer
    • Cohort 2: Bladder cancer
    • Cohort 3: Cervical cancer
    • Cohort 4: Endometrial cancer
    • Cohort 5: Epithelial ovarian cancer
    • Cohort 6: Pancreatic cancer
    • Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.
  • Part 2:The respective cohorts for patient inclusion are:

    • Cohort A: Metastatic or advanced solid tumors that are HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer). Patients with non-small cell lung cancer can be included.
    • Cohort B: Metastatic or advanced solid tumors that are HER2 IHC 2+/ISH+ any tumor type (excluding breast, gastric cancer, and colorectal cancer). Patients with non-small cell lung cancer can be included.
    • Cohort C: Metastatic or advanced solid endometrial cancer that is HER2 IHC 2+ or 1+.
    • Cohort D: Metastatic or advanced ovarian cancer that is HER2 IHC 2+ or 1+.
    • Cohort E: Metastatic or advanced solid cervical cancer that is HER2 IHC 2+ or 1+.
  • Progressed following prior treatment or who have no satisfactory alternative treatment option.
  • Prior HER2 targeting therapy is permitted.
  • HER2 expression scored using current ASCO/CAP guidelines for scoring HER2 for gastric cancer.

    • Part 1: IHC 3+ or IHC 2+ by local or central assessment
    • Part 2: IHC and ISH results by central assessment as pre-defined for each cohort
  • Has measurable target disease assessed by the Investigator based on RECIST version 1.1.
  • Has protocol- defined adequate organ function including cardiac, renal and hepatic function.

Exclusion Criteria:

  • History of non-infectious pneumonitis/ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening
  • Lung-specific intercurrent clinically significant severe illnesses
  • Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
  • Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART
  • Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression.
  • Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer for Part 1. For Part 2, patients with primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction will be excluded.
  • Medical conditions that may interfere with the subject's participation in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   Czechia,   India,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Russian Federation,   Spain,   Taiwan,   Thailand,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04482309
Other Study ID Numbers  ICMJE D967VC00001
2020-001574-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria:

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool .

Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.

For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Current Responsible Party AstraZeneca
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Daiichi Sankyo Co., Ltd.
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP