Glumetinib plus albumin-bound docetaxel for advanced stomach/GEJ cancer 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

This trial tests whether adding Glumetinib to albumin-bound docetaxel helps adults with advanced gastric or gastroesophageal junction adenocarcinoma and other MET-positive solid tumors.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06947291 on ClinicalTrials.gov

What this trial studies

This Phase 2 program includes an initial dose-escalation and expansion stage followed by a randomized, controlled, open-label, multicenter proof-of-concept stage. Participants receive oral Glumetinib combined with albumin-bound docetaxel and are selected for MET overexpression or amplification confirmed by a central lab. Key eligibility includes measurable or evaluable disease, ECOG 0–1, adequate organ function, and expected survival of at least three months. The trial will measure safety and anti-tumor activity to determine appropriate dosing and preliminary clinical benefit.

Who should consider this trial

Good fit: Adults (≥18 years) with advanced gastric/GEJ adenocarcinoma or other solid tumors that show MET overexpression/amplification, who have ECOG performance status 0–1, measurable or evaluable disease, adequate organ and bone marrow function, and can give informed consent are ideal candidates.

Not a fit: Patients without MET overexpression/amplification, with ECOG >1, poor organ or bone marrow function, life expectancy under three months, or who cannot tolerate chemotherapy are unlikely to benefit from this regimen.

Why it matters

Potential benefit: If successful, the combination could improve tumor control and potentially prolong progression-free or overall survival for MET-positive patients with advanced gastric/GEJ cancer or other solid tumors.

How similar studies have performed: Some MET-targeted therapies have shown promise in MET-amplified cancers, but combining a MET inhibitor like Glumetinib with albumin-bound docetaxel is relatively novel and being tested for clinical benefit.

Eligibility criteria

Inclusion Criteria:

* 1\. Patients who are able to understand and voluntarily sign the written ICF;
* 2\. Male or female patients aged ≥ 18 years (inclusive);
* 3\. Patients with advanced solid tumors diagnosed by pathology or cytology;
* 4\. Patients with a past medical history showing either negative or positive Her-2 expression can be enrolled. For those with unknown Her-2 expression, the Her-2 status needs to be determined before enrollment. For patients with positive Her-2 expression, their previous treatments should include anti-Her-2 drug therapy.
* 5\. Overexpression and/or amplification of MET in tumor tissue specimens/blood samples confirmed by the central laboratory.
* 6\. There are measurable lesions or non-measurable but evaluable lesions according to RECIST v1.1.
* 7\. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score is 0 or 1.
* 8\. The expected survival time is ≥ 3 months.
* 9\. The functions of major organs and bone marrow meet the criteria.

Exclusion Criteria:

* 1\. Patients with prior treatment with targeted MET drugs;
* 2\. Previous treatments included docetaxel;
* 3\. Patients with meningeal metastases, spinal cord compression, symptomatic or progressive brain metastases are not eligible for enrollment.
* 4\. Known hypersensitivity or intolerable conditions to any component of the drugs in the study protocol or their excipients.
* 5\. According to NCI-CTCAE 5.0, adverse events caused by previous anti-tumor treatment have not recovered to ≤ Grade 1 (excluding toxicities such as Grade 2 alopecia which are judged by the investigator to pose no safety risk).
* 6\. Any severe and/or uncontrolled co-existing diseases that may prevent the patient from participating in the study.
* 7\. Female patients who are lactating or pregnant; Women of childbearing potential with a positive blood pregnancy test result within 7 days before trial enrollment. Lactating women can participate in this study if they stop breastfeeding, but they must not resume breastfeeding during and after the completion of the study treatment.
* 8\. Any male or female patient of childbearing potential who refuses to use a highly effective contraceptive method throughout the trial period and within 6 months after the last administration.
* 9\. Those who are unwilling or unable to comply with the study procedures and requirements, or those who, in the judgment of the investigator, are not suitable for participating in this study.

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Clinical Trials Information Group officer

Conditions Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors