An Open-label, Single-arm, Multicenter Phase II Study to Evaluate the Efficacy of Amivantamab in Combination With FOLFIRI as a Second-line Treatment in Patients With RAS/BRAF Wild-type Advanced Colorectal Cancer Progressing on Prior Anti-EGFR Based Treatment.

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

May 31, 2025

Primary Completion Date

May 31, 2027

Study Completion Date

December 31, 2027

Conditions
RAS/BRAF Wild-type Advanced Colorectal Cancer Patients
Interventions
DRUG

Amivantamab + FOLFIRI

"The dosage of amivantamab will be based on the participant's body weight during screening. Participants will receive 1,050 mg if BW is \<80 kg or 1,400 mg if BW is ≥80 kg.~* Cycle 1: once weekly (with the first dose split over Day -2 \[350 mg, IVF for 4-6hrs\] and Day -1 \[remainder of the dose, IVF for 6-8hrs\]; subsequent dose \[planned dose IVF over 2 hrs\]).~* Cycles 2+: Days 1 and 15 of each cycle (planned dose IVF over 2 hrs) On days when both amivantamab and chemotherapy are administered, amivantamab should be administered before chemotherapy. In general, leucovorin 400 mg/m2 IV over 2 hours and irinotecan 180 mg/m2 IV over 90 min, then 5-FU 400 mg/m2 IV bolus followed by 5-FU continuous infusion 2,400 mg/m2 over approximately 46-48 hours or 1,200 mg/m2/day for two days. Irinotecan and leucovorin may be administered concurrently (via separate infusion lines) or sequentially according to the institutional standard."

Trial Locations (1)

Unknown

Severance Hospital, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER