Clinical Trial

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

Study acronym: DTP-HER2
Not Yet Recruiting Phase 2
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.
Trial Details
NCT Number NCT07507526
Lead Sponsor Sun Yat-sen University
Collaborators: Shanghai Kechow Pharma, Inc., BeOne Medicines, RemeGen Co., Ltd.
Conditions Gastric Adenocarcinoma
Enrollment 76 participants
Start Date 2026-04
Primary Completion 2028-04-30 (estimated)
Study Completion 2028-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-02