A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer

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).

Trial Details

NCT ID

NCT05379595

Phase

PHASE1 / PHASE2

Sponsor

Janssen Research & Development, LLC

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

Amivantamab IV
Fluorouracil
Leucovorin
Oxaliplatin
Irinotecan
Amivantamab

Locations (sample)

Birmingham, Alabama, United States|33.52066,-86.80249
Los Angeles, California, United States|34.05223,-118.24368
Los Angeles, California, United States|34.05223,-118.24368
Washington D.C., District of Columbia, United States|38.89511,-77.03637
Tampa, Florida, United States|27.94752,-82.45843

Key Eligibility Criteria

Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the col…
Participant must have tumor previously characterized as having wild-type Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogen…
Phase (Ph) 2 (Cohorts A, B, and C) Amivantamab monotherapy: Participant must have received at least 2 but not more than 3 prior lines of systemic t…
Ph 1b Dose Confirmation Cohorts (Ph1b-D and Ph1b-E), Ph2 (Cohorts D and E) Amivantamab+mFOLFOX6/FOLFIRI: Participant must been diagnosed with CRC a…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Colorectal Cancer Trials on Trialify →