Glumetinib and Docetaxel for Advanced Gastric Cancer
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
Recruiting
Phase 2Interventional Study
Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
350 (estimated)
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
Who this trial is looking for
This trial is looking for adults with advanced solid tumors. Participants will receive a combination treatment and will be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have advanced solid tumors.
I understand and can sign the consent form.
I have measurable or evaluable lesions.
I have a Her-2 status that is known or has been determined.
I have a good performance status score of 0 or 1.
My expected survival time is at least 3 months.
My major organ and bone marrow function meets the study criteria.
You may not be able to join if
I have had prior treatment with targeted MET drugs.
I have previous treatment that included docetaxel.
I have meningeal metastases or symptomatic brain metastases.
I am hypersensitive to any of the study drugs.
I have not recovered from previous treatment side effects to a grade of 1 or less.
I have severe uncontrolled health issues.
I am pregnant or breastfeeding.
I do not plan to use effective contraception if applicable.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
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 nega…
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.
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