Study on Amivantamab Alone and with Standard Chemotherapy for Advanced or Metastatic Colorectal Cancer
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT05379595
This clinical trial is exploring the effectiveness and safety of a new drug, amivantamab, used alone or with standard chemotherapy in patients with advanced or metastatic colorectal cancer. The study aims to find the best dose for future treatments.
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Program Overview
The study aims to evaluate how well amivantamab, a new drug, works against tumors in patients with advanced or metastatic colorectal cancer. It will also assess the safety of using amivantamab with standard chemotherapy and determine the best dose for future studies. Participants will receive the treatment in cycles and be monitored for up to four years.
Description
Colorectal cancer is a common and serious health issue worldwide. This study is testing a new drug called amivantamab, which is designed to target specific proteins involved in cancer growth. Amivantamab has shown promise in treating certain lung cancers and may help in colorectal cancer by overcoming resistance to existing treatments.
Participants will be divided into different groups to receive amivantamab either alone or with standard chemotherapy. The study will involve a screening period, followed by treatment cycles lasting 28 days each. The safety and effectiveness of the treatment will be monitored through physical exams, lab tests, and tracking any side effects. The study will last up to four years and three months.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of advanced colorectal cancer that cannot be surgically removed.
- For certain groups, must have disease that can be measured or evaluated by scans.
- Must be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must agree to a biopsy of the tumor for study purposes.
- Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception during the study.
Exclusion Criteria
- Cannot have specific genetic mutations related to cancer growth, as identified by a blood test.
- Cannot have untreated or symptomatic cancer that has spread to the brain.
- Cannot have a history of cancer spreading to the membranes around the brain and spinal cord.
- Cannot have any condition that the study doctor believes would make participation unsafe or interfere with the study.
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