NCT06947291RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 8 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 21 Apr 2025
- Start date
- 4 Jun 2025
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06947291
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 350
- From 4 Jun 2025 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1\. Patients with prior treatment with targeted MET drugs;
- 2\. Previous treatments included docetaxel;
- 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).
- 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.
Other illness
- 4\. Known hypersensitivity or intolerable conditions to any component of the drugs in the study protocol or their excipients.
- 6\. Any severe and/or uncontrolled co-existing diseases that may prevent the patient from participating in the study.
Other
- 3\. Patients with meningeal metastases, spinal cord compression, symptomatic or progressive brain metastases are not eligible for enrollment.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.