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

NCT07507526 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

  • Gastric Adenocarcinoma

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

Sponsors & Collaborators

  • Shanghai Kechow Pharma, Inc.

    collaborator INDUSTRY

  • BeOne Medicines

    collaborator INDUSTRY

  • RemeGen Co., Ltd.

    collaborator INDUSTRY

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-04-30
Completion
2028-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07507526 on ClinicalTrials.gov