A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors
A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) as Monotherapy or in Combination With Anti-cancer Agents for the Treatment of Patients With Selected HER2-expressing Tumors (DESTINY PanTumor03)
1 other identifier
interventional
127
1 country
29
Brief Summary
This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan as monotherapy or in combination with anti-cancer agents for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2-expressing solid tumors which are not eligible for curative therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2024
Typical duration for phase_2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2024
CompletedFirst Posted
Study publicly available on registry
February 22, 2024
CompletedStudy Start
First participant enrolled
February 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2027
ExpectedMay 11, 2026
April 1, 2026
1.8 years
January 19, 2024
May 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Confirmed Objective Response Rate (ORR)
Confirmed ORR is the proportion of patients who have a confirmed complete response or confirmed partial response per RECIST 1.1.
An average of approximately 12 months
Secondary Outcomes (8)
Duration of Response (DoR)
An average of approximately 12 months
Disease control rate (DCR)
An average of approximately 12 months
Confirmed best objective response (BOR)
An average of approximately 12 months
Progression-free survival (PFS)
An average of approximately 12 months
Overall survival (OS)
An average of approximately 12 months
- +3 more secondary outcomes
Study Arms (4)
Part 1
EXPERIMENTALHER2 IHC 3+ solid tumors (excluding breast and gastric cancer)
Part 2 Cohort A
EXPERIMENTALHER2 IHC 2+ solid tumors (excluding breast and gastric cancer)
Part 2 Cohort B
EXPERIMENTALHER2 IHC 1+ gynecologic cancers
Part 3
EXPERIMENTALHER2 IHC 3+ or 2+ cervical cancer
Interventions
Trastuzumab deruxtecan by intravenous infusion
Eligibility Criteria
You may qualify if:
- At least 18 years of age.
- Locally advanced, unresectable, or metastatic solid tumors based on most recent imaging.
- HER2 expression.
- ECOG performance status of 0-1.
- Must provide an adequate FFPE tumor sample to centrally determine HER2 status and other correlatives.
- Has measurable target disease assessed by the investigator based on RECIST 1.1.
- Adequate organ function and bone marrow within 14 days before enrollment.
- Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent.
- Provision of signed and dated written ICF prior to mandatory study-specific procedures, sampling, or analyses.
- Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.
You may not qualify if:
- Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the gastric body or gastroesophageal junction.
- Has substance abuse or any other medical conditions that may interfere with the patient's participation in the clinical study or evaluation of the clinical study results.
- A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and concentrated ascites reinfusion therapy.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated.
- Has unresolved toxicities from previous anti cancer therapy.
- Has any spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.
- Uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals, or active infection including tuberculosis.
- Active primary immunodeficiency, known uncontrolled active HIV infection, or active Hepatitis B or C infection.
- Protocol-defined inadequate cardiac function.
- History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Has a concomitant medical condition that would increase the risk of toxicity in the opinion of the investigator.
- Anti cancer chemotherapy without an adequate treatment washout period prior to enrollment.
- Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.
- Known allergy or hypersensitivity to study treatment or any excipients of the product or other mAbs.
- Involvement in the planning and/or conduct of the study.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Daiichi Sankyo Co., Ltd.collaborator
Study Sites (29)
Research Site
Beijing, 100142, China
Research Site
Beijing, 100191, China
Research Site
Changchun, 130021, China
Research Site
Changsha, 410013, China
Research Site
Chengdu, 610041, China
Research Site
Chongqing, 400030, China
Research Site
Dongyang, 322100, China
Research Site
Guangzhou, 510145, China
Research Site
Guangzhou, 510630, China
Research Site
Hangzhou, 310003, China
Research Site
Hangzhou, 310016, China
Research Site
Hangzhou, 310022, China
Research Site
Harbin, 150081, China
Research Site
Hefei, 230031, China
Research Site
Kunming, 650118, China
Research Site
Lishui, 323000, China
Research Site
Nanchang, 330029, China
Research Site
Shandong, China
Research Site
Shanghai, 200001, China
Research Site
Shanghai, 200011, China
Research Site
Shanghai, 200032, China
Research Site
Shenyang, 110016, China
Research Site
Taiyuan, 030001, China
Research Site
Wuhan, 430022, China
Research Site
Xi'an, 710061, China
Research Site
Xuzhou, 221009, China
Research Site
Yinchuan, 750004, China
Research Site
Zhengzhou, 450002, China
Research Site
Zhengzhou, 450008, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- This study is Open-Label Study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2024
First Posted
February 22, 2024
Study Start
February 22, 2024
Primary Completion
November 28, 2025
Study Completion (Estimated)
February 10, 2027
Last Updated
May 11, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer 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 anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests 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 approved.