New drug combo shows promise for hard-to-treat HER2 cancers

NCT ID NCT06271837

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests a drug called trastuzumab deruxtecan, alone or with other medicines, in people with advanced solid tumors that have a protein called HER2. The goal is to see if the drug can shrink or control these cancers. About 127 adults with tumors that cannot be removed by surgery or have spread will take part.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

127 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors (excluding gastric cancer and breast cancer)

Contacts and locations

Locations

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

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