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

April 8, 2026 updated by: AstraZeneca

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

477

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Auchenflower, Australia, 4066
        • Research Site
      • Blacktown, Australia, 2148
        • Research Site
      • Camperdown, Australia, 2050
        • Research Site
      • Heidelberg, Australia, 3084
        • Research Site
      • Melbourne, Australia, 3000
        • Research Site
      • Nedlands, Australia, 6009
        • Research Site
  • Belgium
      • Brussels, Belgium, 1090
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
  • Brazil
      • Porto Alegre, Brazil, 90035-000
        • Research Site
      • São Paulo, Brazil, 01246-000
        • Research Site
      • Vitória, Brazil, 29043-272
        • Research Site
  • Canada
      • Montreal, Canada, H3T 1E2
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Site
    • Quebec
      • Québec, Quebec, Canada, G1J 1Z4
        • Research Site
  • Czechia
      • Brno, Czechia, 656 53
        • Research Site
      • Hradec Králové, Czechia, 500 05
        • Research Site
      • Olomouc, Czechia, 77900
        • Research Site
      • Prague, Czechia, 150 06
        • Research Site
      • Prague, Czechia, 180 81
        • Research Site
  • India
      • Delhi, India, 110085
        • Research Site
      • Gūrgaon, India, 122001
        • Research Site
      • Kolkata, India, 700160
        • Research Site
      • Mumbai, India, 400012
        • Research Site
  • Italy
      • Milan, Italy, 20141
        • Research Site
      • Milan, Italy, 20162
        • Research Site
      • Naples, Italy, 80131
        • Research Site
      • Rome, Italy, 168
        • Research Site
  • Japan
      • Chūōku, Japan, 104-0045
        • Research Site
      • Kashiwa, Japan, 277-8577
        • Research Site
      • Suita-shi, Japan, 565-0871
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1066CX
        • Research Site
      • Delft, Netherlands, 2625 AD
        • Research Site
      • Groningen, Netherlands, 9700
        • Research Site
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Research Site
      • Gdansk, Poland, 80-952
        • Research Site
      • Krakow, Poland, 31-501
        • Research Site
      • Poznan, Poland, 60-355
        • Research Site
      • Warsaw, Poland, 02-781
        • Research Site
  • Russia
      • Kaluga, Russia, 248007
        • Research Site
      • Moscow, Russia, 115478
        • Research Site
      • Moscow, Russia, 117997
        • Research Site
      • Moscow, Russia, 121205
        • Research Site
      • Moscow, Russia, 143423
        • Research Site
      • Moscow, Russia, 143442
        • Research Site
      • Moscow, Russia, 115419
        • Research Site
      • Saint Petersburg, Russia, 197758
        • Research Site
      • Saint Petersburg, Russia, 195271
        • Research Site
  • South Korea
      • Seoul, South Korea, 03080
        • Research Site
      • Seoul, South Korea, 03722
        • Research Site
      • Seoul, South Korea, 06351
        • Research Site
      • Seoul, South Korea, 5505
        • Research Site
  • Spain
      • Barcelona, Spain, 8035
        • Research Site
      • Córdoba, Spain, 14004
        • Research Site
      • Madrid, Spain, 28046
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Madrid, Spain, 28027
        • Research Site
      • Valencia, Spain, 46014
        • Research Site
  • Taiwan
      • Taichung, Taiwan, 40705
        • Research Site
      • Tainan, Taiwan, 736
        • Research Site
      • Taipei, Taiwan, 100
        • Research Site
      • Taipei, Taiwan, 10449
        • Research Site
      • Taipei, Taiwan, 11217
        • Research Site
      • Taoyuan District, Taiwan, 333
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10210
        • Research Site
      • Bangkok, Thailand, 10330
        • Research Site
      • Bangkok, Thailand, 10400
        • Research Site
      • Chiang Mai, Thailand, 50200
        • Research Site
      • Hat Yai, Thailand, 90110
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
      • Muang, Thailand, 50200
        • Research Site
      • Ongkharak, Thailand, 26120
        • Research Site
  • United Kingdom
      • London, United Kingdom, SW2 6JJ
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Sutton, United Kingdom, SM2 5PT
        • Research Site
  • United States
    • California
      • Duarte, California, United States, 91010
        • Research Site
      • Santa Rosa, California, United States, 95403
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Research Site
    • Indiana
      • Muncie, Indiana, United States, 47303
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Research Site
    • New Jersey
      • Middletown, New Jersey, United States, 07748
        • Research Site
    • New York
      • Harrison, New York, United States, 10604
        • Research Site
      • New York, New York, United States, 10065
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98195
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
An average of approximately 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 12 months
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).
Up to 12 months
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.
An average of approximately 6 months
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).
An average of approximately 6 months
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.
An average of approximately 6 months
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.
An average of approximately 14 months
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.
An average of approximately 8 months
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
An average of approximately 8 months
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.
An average of approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Daiichi Sankyo Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2020

Primary Completion (Estimated)

March 23, 2027

Study Completion (Estimated)

March 23, 2027

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D967VC00001
  • 2020-001574-29 (EudraCT Number)
  • 2023-504721-39-02 (Registry Identifier: EU CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer

Clinical Trials on Trastuzumab deruxtecan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe