Glumetinib combined withFruquintinib in the treatment of MET amplification or protein overexpression in third-line unresectable metastatic colorectal cancer: evaluation of efficacy and safety
The patients fully understood this study, voluntarily participated and signed the Informed Consent Form (ICF);
Age ≥18 years old;
Patients with unresectable metastatic colorectal cancer with microsatellite stable (MSS) confirmed by pathology or histology;
Have MET amplification (FISH MET GCN≥4 or MET/CEP7≥1.8; Or NGS, ≥20% of tumor cells, ≥200X sequencing depth, GCN≥4) or overexpression (IHC, 3+(≥50% of tumor cells are strongly positive) or 2+ (≥50% of tumor cells are moderately positive/strongly positive and < 50% of tumor cells are strongly positive); Immunohistochemistry (IHC) detection showed that the MET protein overexpression in the subjects was 3+(strongly positive in ≥50% of tumor cells) or 2+ (positive in ≥50% of tumor cells/weakly positive and strongly positive in < 50% of tumor cells).
None
Single group
Glumetinib Combined with Fruquintinib
DrugFruquintinib: 3mg, po.qd, d1-14，q3w; Guemitinib: Grade 1:200mg, po, qd, q3w; Grade 2:250mg, po, qd, q3w; Phase I: The dose of Glumetinib (200 mg → 250 mg) is dynamically adjusted using the "3+3 dose-escalation rule" to determine the optimal dose of Fruquintinib. Phase II: The RP2D (Recommended Phase II Dose) of Glumetinib identified in Phase I is continued in combination with Fruquintinib.
Recommended dose for Phase II
The dose determined during dose-escalation trials for use in Phase II studies, typically based on safety and tolerability data.
Objective response rate(ORR)
In the phase II study,CR + PR rate according to the RECIST version 1.1 guidelines.
Maximum tolerated dose(MTD)
The highest dose identified in dose-escalation trials that does not cause dose-limiting toxicities (DLTs).
Dose-limiting toxicity（DLT）
Severe or intolerable toxicity events related to the study drug within a specified time window, which may influence dose-escalation decisions.
Assess Adverse Events
Assess adverse events according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Disease control rate（DCR）
Proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD).
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Liu Huang
Lead sponsor
Tongji Hospital
Sponsor institution
