Glumetinib Combined With Fruquintinib in the Treatment of MET Amplification or Protein Overexpression in Third-Line Unresectable Metastatic Colorectal Cancer

Sponsor
Liu Huang
Study ID
NCT06980532
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glumetinib Combined with Fruquintinib — DRUG
    Fruquintinib: 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.

Study Details

Glumetinib combined withFruquintinib in the treatment of MET amplification or protein overexpression in third-line unresectable metastatic colorectal cancer: evaluation of efficacy and safety

Key Dates

First listed
May 20, 2025
Start date
Apr 25, 2025
Status verified
May 2025
Primary completion
Dec 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Glumetinib combined with Fruquintinib

Primary Outcome Measure

Recommended dose for Phase II [ Time Frame: Up to approximately 18 Weeks ]

Central Contacts

Related Studies