Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid TumorsPhase 2NCT06947291
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 Phase 2 study testing Glumetinib Tablets and Docetaxel for Injection (Albumin-bound) in people with Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors
- What is being tested?
- Glumetinib Tablets and Docetaxel for Injection (Albumin-bound)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2025to 30 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Xiangdong Cheng, Chengxd516@126.com
About this study
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
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.
- Being tested
- Glumetinib Tablets, Docetaxel for Injection (Albumin-bound)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glumetinib TabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Glumetinib combined with Docetaxel for Injection (Albumin-bound) | Experimental | 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). Receives: Drug: Glumetinib Tablets; Drug: Docetaxel for Injection (Albumin-bound) |
| Glumetinib | Active comparator | 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). Receives: Drug: Glumetinib Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation and cohort expansion phase: The occurrence and frequency of DLT (Dose-Limiting Toxicity)
Measured: Up to approximately 24 months after the first patient is enrolled
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)
Measured: Up to approximately 24 months after the first patient is enrolled
Dose escalation and cohort expansion phase: Recommended Phase 2 Dose (RP2D) for the combination therapy.
Measured: Up to approximately 24 months after the first patient is enrolled
Proof-of-concept phase: Objective Response Rate (ORR) evaluated by the Independent Review Committee (IRC) according to the RECIST 1.1 criteria.
Measured: Up to approximately 24 months after the first patient is enrolled
Secondary outcomes (13)
Dose escalation and cohort expansion phase: Evaluated by the Investigator according to the RECIST 1.1 criteria: Objective Response Rate (ORR)
Measured: Up to approximately 24 months after the first patient is enrolled
Dose escalation and cohort expansion phase: Evaluated by the Investigator according to the RECIST 1.1 criteria: Disease Control Rate (DCR)
Measured: Up to approximately 24 months after the first patient is enrolled
Dose escalation and cohort expansion phase: Evaluated by the Investigator according to the RECIST 1.1 criteria: Duration of Response (DoR)
Measured: Up to approximately 24 months after the first patient is enrolled
Dose escalation and cohort expansion phase: Evaluated by the Investigator according to the RECIST 1.1 criteria: Progression-Free Survival (PFS)
Measured: Up to approximately 24 months after the first patient is enrolled
Dose escalation and cohort expansion phase: Overall Survival (OS)
Measured: Up to approximately 24 months after the first patient is enrolled
Proof-of-concept study：Evaluated by the Independent Review Committee (IRC) according to the RECIST 1.1 criteria: Disease Control Rate (DCR)
Measured: Up to approximately 24 months after the first patient is enrolled
Proof-of-concept study：Evaluated by the Independent Review Committee (IRC) according to the RECIST 1.1 criteria:Duration of Response (DoR)
Measured: Up to approximately 24 months after the first patient is enrolled
Proof-of-concept study：Evaluated by the Independent Review Committee (IRC) according to the RECIST 1.1 criteria: Progression-Free Survival (PFS)
Measured: Up to approximately 24 months after the first patient is enrolled
Proof-of-concept study： Evaluated by the Investigator according to the RECIST 1.1 criteria: Objective Response Rate (ORR)
Measured: Up to approximately 24 months after the first patient is enrolled
Proof-of-concept study：Evaluated by the Investigator according to the RECIST 1.1 criteria: Disease Control Rate (DCR)
Measured: Up to approximately 24 months after the first patient is enrolled
Proof-of-concept study：Evaluated by the Investigator according to the RECIST 1.1 criteria: Duration of Response (DoR)
Measured: Up to approximately 24 months after the first patient is enrolled
Proof-of-concept study： Evaluated by the Investigator according to the RECIST 1.1 criteria: Progression-Free Survival (PFS)
Measured: Up to approximately 24 months after the first patient is enrolled
Proof-of-concept study： Overall Survival (OS)
Measured: Up to approximately 24 months after the first patient is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start4 Jun 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid TumorsStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947291
- Sponsor's protocol ID
- SYH2065-004
- Status last verified
- Sep 2025
- First submitted
- 21 Apr 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06947291
- Acronym / sponsor ID
- SYH2065-004
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glumetinib combined with Docetaxel for Injection (Albumin-bound) | Experimental | Drug: Glumetinib Tablets, Drug: 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). |
| Glumetinib | Active comparator | Drug: Glumetinib TabletsPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glumetinib Tabletsglumetinib once daily once daily under fasting conditions in each 21-day treatment cycle. | Drug | Glumetinib, Glumetinib combined with Docetaxel for Injection (Albumin-bound) |
| Docetaxel for Injection (Albumin-bound)Docetaxel for Injection (Albumin-bound) by intravenous injection in each 21-day treatment cycle. | Drug | Glumetinib combined with Docetaxel for Injection (Albumin-bound) |
Primary outcome
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
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
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
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
13 secondary outcomes
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
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
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
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
Dose escalation and cohort expansion phase: Overall Survival (OS)
Time frame: Up to approximately 24 months after the first patient is enrolled
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
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
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
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
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
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
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
Proof-of-concept study： Overall Survival (OS)
Time frame: Up to approximately 24 months after the first patient is enrolled
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glumetinib Tablets and Docetaxel for Injection (Albumin-bound) in people with Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.