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Treatment for advanced HER2-expressing tumors using trastuzumab deruxtecan

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)

Phase 2 Interventional AstraZeneca · NCT06271837

This study is testing a new cancer treatment called trastuzumab deruxtecan to see if it helps people with advanced tumors that have HER2 and can't be treated with surgery.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment175 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy, trastuzumab
Locations31 sites (Beijing and 30 other locations)
Trial IDNCT06271837 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase II study evaluates the efficacy and safety of trastuzumab deruxtecan, both as a standalone treatment and in combination with other anti-cancer agents, for patients with locally advanced, unresectable, or metastatic solid tumors that express HER2. The study focuses on patients who are not eligible for curative therapy and aims to assess the treatment's impact on disease progression and overall health outcomes. Participants will undergo regular assessments to monitor their response to the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with locally advanced or metastatic HER2-expressing solid tumors that are not amenable to curative therapy.

Not a fit: Patients with primary adenocarcinoma or those whose tumors do not express HER2 may not benefit from this treatment.

Why it matters

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

How similar studies have performed: Other studies have shown promising results with trastuzumab deruxtecan in HER2-expressing tumors, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
* Previous enrollment in the present study. Concurrent enrollment in another therapeutic clinical study (excluding observational studies).
* For females only: Currently pregnant or breast feeding, or who are planning to become pregnant.

Where this trial is running

Beijing and 30 other locations

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 Advanced Solid Tumors
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.