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NOT YET RECRUITING
NCT07507526
PHASE2

A Study of Disitamab Vedotin, Tunlametinib, and PD-1 Antibody for Advanced Gastric Cancer

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if the combination of disitamab vedotin, tunlametinib, and a PD-1 antibody works to treat HER2-overexpressing advanced gastric cancer in patients who have already received at least two lines of prior therapy. It will also learn about the safety of this combination therapy. The main questions it aims to answer are: What is the objective response rate (tumor shrinkage) in participants receiving this combination? What medical problems (side effects) do participants have when taking this combination? Researchers will evaluate the efficacy and safety of disitamab vedotin combined with tunlametinib and a PD-1 antibody in patients with HER2-overexpressing advanced gastric cancer who have failed at least two lines of standard treatment. Participants will: Receive disitamab vedotin intravenously every 2 weeks and a PD-1 antibody intravenously once every 6 weeks. Take tunlametinib orally every 12 hours. Continue treatment until disease progression or unacceptable toxicity. Visit the clinic every 2 weeks for checkups, blood tests, and safety monitoring. Undergo tumor imaging assessments every 6 weeks to evaluate treatment response.

Official title: A Study on the Efficacy and Safety of Disitamab Vedotin Combined With Tunlametinib and PD-1 Antibody in Third-Line and Above Treatment of Patients With HER2-Overexpressing Advanced Gastric Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2026-04

Completion Date

2028-04-30

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

Tunlametinib+PD-1 mAb

Disitamab vedotin (RC48): 2.5 mg/kg intravenously on Day 1 of each 14-day cycle Tislelizumab: 400 mg intravenously on Day 1 of each 42-day cycle Tunlametinib: Orally every 12 hours at the dose determined during the safety run-in phase

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China