Glumetinib plus albumin-bound docetaxel for advanced stomach/GEJ cancer and other solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Clinical Trials Information Group officer
• Email: ctr-contact@cspc.cn
• Phone: 86-0311-69085587

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.