RecruitingPhase 2NCT06947291

Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors

A Multicenter, Open-label, Phase II Clinical Study to Evaluate the Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors With MET Overexpression and/or Amplification


Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Enrollment

350 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The trial consists of Stage 1 (including dose escalation and dose expansion) and Stage 2 (proof-of-concept study). Among them, Stage 2 adopts a randomized, controlled, open-label, and multicenter design.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a drug called glumetinib with a chemotherapy called albumin-bound docetaxel is safe and effective for people with advanced gastric (stomach) or gastroesophageal junction cancer, as well as other solid tumors. Glumetinib targets the MET protein, which is overactive in some tumors. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with an advanced solid tumor (including stomach or GEJ cancer) confirmed by biopsy - Your tumor has overexpression or amplification of the MET protein/gene - If HER2-positive: you have already received anti-HER2 treatment - You are in adequate physical health for chemotherapy **You may NOT be eligible if...** - Your cancer has not been tested for MET status, or it is MET-negative - You have not received prior anti-HER2 therapy if your tumor is HER2-positive - Your organ function (liver, kidneys, blood counts) is insufficient for chemotherapy - You have active infections or serious other medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGlumetinib Tablets

glumetinib once daily once daily under fasting conditions in each 21-day treatment cycle.

DRUGDocetaxel for Injection (Albumin-bound)

Docetaxel for Injection (Albumin-bound) by intravenous injection in each 21-day treatment cycle.


Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06947291