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

NCT ID: NCT06947291

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-04
• Study Completion Date: 2027-10-30

Brief 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.

Conditions

Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Glumetinib combined with Docetaxel for Injection (Albumin-bound)

Patients will be administered glumetinib once daily and Docetaxel for Injection (Albumin-bound) by intravenous injection in each 21-day treatment cycle. The treatment will continue until PD, death, intolerable toxicity, or withdrawal at the patient's discretion (whichever occurs first).

Group Type: EXPERIMENTAL

Glumetinib Tablets

Intervention Type: DRUG

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

Docetaxel for Injection (Albumin-bound)

Intervention Type: DRUG

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

Glumetinib

Patients will be administered glumetinib once daily in each 21-day treatment cycle. The treatment will continue until PD, death, intolerable toxicity, or withdrawal at the patient's discretion (whichever occurs first).

Group Type: ACTIVE_COMPARATOR

Glumetinib Tablets

Intervention Type: DRUG

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

Interventions

Glumetinib Tablets

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

Intervention Type: DRUG

Docetaxel for Injection (Albumin-bound)

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Clinical Trials Information Group officer

Role: CONTACT

ctr-contact@cspc.cn

86-0311-69085587

Facility Contacts

Xiangdong Cheng

Role: primary

Chengxd516@126.com

Other Identifiers

SYH2065-004

Identifier Type: -

Identifier Source: org_study_id