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Treatment of selected HER2-expressing tumors with T-DXd

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)

Phase 2 Interventional AstraZeneca · NCT04482309

This study is testing a new treatment called T-DXd to see if it can help people with certain types of HER2-expressing tumors feel better and improve their health.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment468 (estimated)
Ages18 Years to 120 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsCART, trastuzumab
Locations123 sites (Burbank, California and 122 other locations)
Trial IDNCT04482309 on ClinicalTrials.gov

What this trial studies

This Phase 2 study evaluates the efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with selected HER2-expressing tumors. The study is divided into two parts: Part 1 includes cohorts for various cancers such as bladder, biliary tract, cervical, endometrial, ovarian, pancreatic, and rare tumors, while Part 2 focuses on HER2-expressing solid tumors excluding breast, gastric, and colorectal cancers. The study aims to determine if T-DXd can provide meaningful clinical activity and a favorable risk-benefit profile for these patients.

Who should consider this trial

Good fit: Ideal candidates include patients with locally advanced, unresectable, or metastatic HER2-expressing tumors, specifically those in the defined cohorts.

Not a fit: Patients with breast, gastric, or colorectal cancers will not benefit from this study as they are excluded from participation.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with HER2-expressing tumors that currently have limited treatment options.

How similar studies have performed: Other studies have shown promising results with HER2-targeted therapies, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Burbank, California and 122 other locations

+73 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal CancerPart 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal CancerT-DXd, DS-8201a, Trastuzumab Deruxtecan, HER2
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.