A Phase 1b/2 Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants with Advanced or Metastatic Colorectal Cancer.

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A Phase 1b/2 Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants with Advanced or Metastatic Colorectal Cancer.

Brief description of study

You can participate in this study if you are diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added to standard-of care chemotherapy in participants with metastatic colorectal cancer (Ph2 cohorts), and to assess the recommended phase 2 combination dose of amivantamab when added to standard-of care chemotherapy (Ph1b cohorts).

Clinical Study Identifier: s22-00147

ClinicalTrials.gov Identifier: NCT05379595

Principal Investigator: Paul E. Oberstein.

Other Investigators: Daniel J Becker, Kristen Spencer, Keriann M Scavone, Nina Beri, Jennifer Chuy, Rafael Winograd, Shun Yu.

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Perlmutter Cancer Center

Clinical Trials & Research Studies