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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

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.


Condition or disease Intervention/treatment Phase
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 Drug: Trastuzumab deruxtecan Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 468 participants
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
Official Title: 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)
Actual Study Start Date : August 18, 2020
Estimated Primary Completion Date : July 30, 2027
Estimated Study Completion Date : July 30, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: Part 1 Cohort 1
Biliary tract cancer
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Other Names:
  • DS-8201a
  • T-DXd

Experimental: Part 1 Cohort 2
Bladder cancer
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Other Names:
  • DS-8201a
  • T-DXd

Experimental: Part 1 Cohort 3
Cervical cancer
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Other Names:
  • DS-8201a
  • T-DXd

Experimental: Part 1 Cohort 4
Endometrial cancer
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Other Names:
  • DS-8201a
  • T-DXd

Experimental: Part 1 Cohort 5
Ovarian cancer
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Other Names:
  • DS-8201a
  • T-DXd

Experimental: Part 1 Cohort 6
Pancreatic cancer
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Other Names:
  • DS-8201a
  • T-DXd

Experimental: Part 1 Cohort 7
Rare tumors
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Other Names:
  • DS-8201a
  • T-DXd

Experimental: Part 2 Cohort A
Any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer)
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Other Names:
  • DS-8201a
  • T-DXd

Experimental: Part 2 Cohort B
Any tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer)
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Other Names:
  • DS-8201a
  • T-DXd

Experimental: Part 2 Cohort C
HER2 IHC 2+ or 1+ endometrial cancer
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Other Names:
  • DS-8201a
  • T-DXd

Experimental: Part 2 Cohort D
HER2 IHC 2+ or 1+ ovarian cancer
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Other Names:
  • DS-8201a
  • T-DXd

Experimental: Part 2 Cohort E
HER2 IHC 2+ or 1+ cervical cancer
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Other Names:
  • DS-8201a
  • T-DXd




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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).

  5. 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.

  6. 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).

  7. 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.

  8. 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

  9. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04482309


Contacts
Layout table for location contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
Show Show 116 study locations
Sponsors and Collaborators
AstraZeneca
Daiichi Sankyo Co., Ltd.
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04482309    
Other Study ID Numbers: D967VC00001
2020-001574-29 ( EudraCT Number )
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: May 22, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
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
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
T-DXd, DS-8201a, Trastuzumab Deruxtecan, HER2
Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Trastuzumab
Trastuzumab deruxtecan
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs