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Recruiting

NCT Number: NCT06947291

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location status: Recruiting

Location contact

Xiangdong Cheng

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glumetinib Tablets

Drug

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

Docetaxel for Injection (Albumin-bound)

Drug

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

Primary outcomes

  1. Dose escalation and cohort expansion phase: The occurrence and frequency of DLT (Dose-Limiting Toxicity)

    Time frame: 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)

    Time frame: 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.

    Time frame: 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.

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: Up to approximately 24 months after the first patient is enrolled

  5. Dose escalation and cohort expansion phase: Overall Survival (OS)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: Up to approximately 24 months after the first patient is enrolled

  13. Proof-of-concept study: Overall Survival (OS)

    Time frame: Up to approximately 24 months after the first patient is enrolled

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Information Group officer

CONTACT

[email protected]

86-0311-69085587

Sponsors and collaborators

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 27, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.