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

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · May 17, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a new treatment called amivantamab for patients with advanced or metastatic colorectal cancer, which means the cancer has spread and cannot be surgically removed. The study aims to see how well amivantamab works on its own and when combined with standard chemotherapy treatments. Researchers will also look at the safety of adding amivantamab to chemotherapy and find the best dose for future studies.

To be eligible for this trial, participants need to have a confirmed diagnosis of unresectable or metastatic colorectal cancer and have a tumor that can be measured or evaluated. They should be in good general health, with a performance status of 0 or 1, which means they are able to carry out normal activities. Women who can become pregnant must have a negative pregnancy test before starting the trial. Participants can expect to undergo regular assessments and biopsies as part of the study. It’s important to know that individuals with certain genetic mutations or untreated brain metastases are not eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum
• • For Phase 1 dose confirmation cohorts (Cohorts Ph1b-D and Ph1b-E): Participant must have evaluable disease. For Phase 2 dose expansion cohorts (Cohorts D and E): Participant must have measurable disease according to Response Criteria in Solid Tumors (RECIST) Version 1.1. If only one measurable lesion exists, it may be used for the screening biopsy as long as baseline tumor assessment scans are performed greater than or equal to (\>=) 7 days after the biopsy
• • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• • Participant must have a tumor lesion amenable for biopsy and agree to mandatory protocol-defined screening biopsy
• • A female participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study. Note: Participant must not be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study
• Exclusion Criteria:
• • Participant with identified mutation in Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B (BRAF), or epidermal growth factor receptor (EGFR) ectodomain, or ERBB2/HER2 amplification by central circulating tumor deoxyribonucleic acid (ctDNA) testing at screening
• • Participant with symptomatic or untreated brain metastasis
• • History or known presence of leptomeningeal disease
• • Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments