Study of Amivantamab Alone or With Chemotherapy for Advanced or Metastatic Colorectal Cancer

What this Trial Is About

Researchers are evaluating the anti-tumor activity and safety of amivantamab, both alone and combined with standard chemotherapy, in people with advanced or metastatic colorectal cancer. This includes assessing the recommended dose when amivantamab is added to chemotherapy. Colorectal cancer is a common cancer worldwide, and this study addresses the role of specific receptors involved in tumor growth and resistance to existing treatments. Participants will receive amivantamab either as a monotherapy or in combination with standard chemotherapy regimens such as mFOLFOX6 or FOLFIRI. Amivantamab is given as an intravenous infusion, with doses adjusted based on body weight and specific cohort assignments. Treatment cycles last 28 days and continue until the study treatment ends or the participant discontinues. The study includes a screening period of up to 28 days before treatment starts. During the study, participants will undergo physical exams, performance status evaluations, laboratory tests, vital sign monitoring, and adverse event tracking to assess safety. Tumor assessments will be performed regularly to evaluate treatment response. The primary outcomes include objective response rates and the number and severity of dose-limiting toxicities and adverse events. The study may last up to several years, with follow-up visits up to 30 days after treatment ends.

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