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.
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.
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.
Parallel
Glumetinib Tablets
Drugglumetinib once daily once daily under fasting conditions in each 21-day treatment cycle.
Docetaxel for Injection (Albumin-bound)
DrugDocetaxel for Injection (Albumin-bound) by intravenous injection in each 21-day treatment cycle.
Dose escalation and cohort expansion phase: The occurrence and frequency of DLT (Dose-Limiting Toxicity)
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)
Dose escalation and cohort expansion phase: Recommended Phase 2 Dose (RP2D) for the combination therapy.
Proof-of-concept phase: Objective Response Rate (ORR) evaluated by the Independent Review Committee (IRC) according to the RECIST 1.1 criteria.
Dose escalation and cohort expansion phase: Evaluated by the Investigator according to the RECIST 1.1 criteria: Objective Response Rate (ORR)
Dose escalation and cohort expansion phase: Evaluated by the Investigator according to the RECIST 1.1 criteria: Disease Control Rate (DCR)
Dose escalation and cohort expansion phase: Evaluated by the Investigator according to the RECIST 1.1 criteria: Duration of Response (DoR)
Dose escalation and cohort expansion phase: Evaluated by the Investigator according to the RECIST 1.1 criteria: Progression-Free Survival (PFS)
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