> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-efficacy-of-glumetinib-combined-with-docetaxel-b1610249-4d6f-484e-9d59-a7933a59a867 > Record changed: 2026-10-13 # 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 NCT06947291 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) Participants 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) Lead sponsor CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) Start date 2025-06-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Official title** 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](https://clinicaltrials.gov/study/NCT06947291) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) ## Dates **Completion date** 2027-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **First posted** 2025-04-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Registry last updated** 2025-09-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Primary completion date** 2027-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Start date** 2025-06-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) ## Size and sites **Participants** 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Planned participants** 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Lead sponsor** CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) ## Identifiers **Registry ID** NCT06947291 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **ClinicalTrials.gov ID** NCT06947291 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) ## Outcomes ### Primary outcomes 1. Dose escalation and cohort expansion phase: The occurrence and frequency of DLT (Dose-Limiting Toxicity) Timeframe: Up to approximately 24 months after the first patient is enrolled 2. Dose escalation and cohort expansion phase: the occurrence and frequency of AE (Adverse Events) and SAE (Serious Adverse Events) (in accordance with NCI-CTCAE 5.0) Timeframe: Up to approximately 24 months after the first patient is enrolled 3. Dose escalation and cohort expansion phase: Recommended Phase 2 Dose (RP2D) for the combination therapy. Timeframe: Up to approximately 24 months after the first patient is enrolled 4. Proof-of-concept phase: Objective Response Rate (ORR) evaluated by the Independent Review Committee (IRC) according to the RECIST 1.1 criteria. Timeframe: Up to approximately 24 months after the first patient is enrolled ### Secondary outcomes 1. Dose escalation and cohort expansion phase: Evaluated by the Investigator according to the RECIST 1.1 criteria: Objective Response Rate (ORR) Timeframe: Up to approximately 24 months after the first patient is enrolled 2. Dose escalation and cohort expansion phase: Evaluated by the Investigator according to the RECIST 1.1 criteria: Disease Control Rate (DCR) Timeframe: Up to approximately 24 months after the first patient is enrolled 3. Dose escalation and cohort expansion phase: Evaluated by the Investigator according to the RECIST 1.1 criteria: Duration of Response (DoR) Timeframe: Up to approximately 24 months after the first patient is enrolled 4. Dose escalation and cohort expansion phase: Evaluated by the Investigator according to the RECIST 1.1 criteria: Progression-Free Survival (PFS) Timeframe: Up to approximately 24 months after the first patient is enrolled 5. Dose escalation and cohort expansion phase: Overall Survival (OS) Timeframe: Up to approximately 24 months after the first patient is enrolled 6. Proof-of-concept study：Evaluated by the Independent Review Committee (IRC) according to the RECIST 1.1 criteria: Disease Control Rate (DCR) Timeframe: Up to approximately 24 months after the first patient is enrolled 7. Proof-of-concept study：Evaluated by the Independent Review Committee (IRC) according to the RECIST 1.1 criteria:Duration of Response (DoR) Timeframe: Up to approximately 24 months after the first patient is enrolled 8. Proof-of-concept study：Evaluated by the Independent Review Committee (IRC) according to the RECIST 1.1 criteria: Progression-Free Survival (PFS) Timeframe: Up to approximately 24 months after the first patient is enrolled 9. Proof-of-concept study： Evaluated by the Investigator according to the RECIST 1.1 criteria: Objective Response Rate (ORR) Timeframe: Up to approximately 24 months after the first patient is enrolled 10. Proof-of-concept study：Evaluated by the Investigator according to the RECIST 1.1 criteria: Disease Control Rate (DCR) Timeframe: Up to approximately 24 months after the first patient is enrolled 11. Proof-of-concept study：Evaluated by the Investigator according to the RECIST 1.1 criteria: Duration of Response (DoR) Timeframe: Up to approximately 24 months after the first patient is enrolled 12. Proof-of-concept study： Evaluated by the Investigator according to the RECIST 1.1 criteria: Progression-Free Survival (PFS) Timeframe: Up to approximately 24 months after the first patient is enrolled 13. Proof-of-concept study： Overall Survival (OS) Timeframe: Up to approximately 24 months after the first patient is enrolled Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) ## Sites - Zhejiang Cancer HospitalHangzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06947291) ## Related records ### Drugs (2) - [Albumin human](https://trialight.com/data/asset/albumin-human-95414b67-0d38-49d4-91b2-27b1c6c17389.md) - [Gumarontinib](https://trialight.com/data/asset/gumarontinib-54f5d71c-06e7-48e2-b5e1-49eb7ab0db7c.md) ### Lead sponsors (1) - [CSPC ZhongQi Pharmaceutical Technology Co., Ltd.](https://trialight.com/data/company/cspc-zhongqi-pharmaceutical-technology-co-ltd-3f55222d-62c5-4f61-b02b-614ae9c6300d.md) ### Conditions (1) - [Gastroesophageal junction adenocarcinoma](https://trialight.com/data/condition/gastroesophageal-junction-adenocarcinoma-de7e280e-cbd1-5266-a5dd-dda00261a706.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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