OncoMatch/Clinical Trials/NCT05379595
A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
Is NCT05379595 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for advanced or metastatic colorectal cancer.
Treatment: Amivantamab IV · Fluorouracil · Leucovorin · Oxaliplatin · Irinotecan · Amivantamab — The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts) and to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts).
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
wild-type Kirsten rat sarcoma viral oncogene (KRAS)
Required: NRAS wild-type
wild-type...neuroblastoma RAS viral oncogene homolog (NRAS)
Required: BRAF wild-type
wild-type...v-raf murine sarcoma viral oncogene homolog B (BRAF)
Required: HER2 (ERBB2) wild-type
without evidence of Erb-b2 receptor tyrosine kinase 2/human epidermal growth factor receptor 2 (ERBB2/HER2) amplification
Required: EGFR ectodomain mutation
Participant with identified mutation in...epidermal growth factor receptor (EGFR) ectodomain
Required: PTEN wild-type
Participant with identified mutation in...PTEN
Required: BRAF V600 wild-type
Participant with identified mutation in...BRAF V600
Required: ALK fusion wild-type
identified fusions in ALK
Required: ROS1 fusion wild-type
identified fusions in ROS-1
Required: RET fusion wild-type
identified fusions in RET
Required: NTRK1 fusion wild-type
identified fusions in NTRK 1
Required: HER2 (ERBB2) amplification wild-type
ERBB2/HER2 amplification
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- O Neal Comprehensive Cancer Center at UAB · Birmingham, Alabama
- University of Southern California · Los Angeles, California
- University of California, Los Angeles UCLA · Los Angeles, California
- Georgetown University Hospital · Washington D.C., District of Columbia
- H Lee Moffitt Cancer Center · Tampa, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify