Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab

Launched by ABBVIE · Oct 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for adults with unresectable metastatic colorectal cancer, which means their cancer cannot be surgically removed and has spread to other parts of the body. The trial is testing an investigational drug called ABBV-400 in combination with standard treatments, including Fluorouracil, Folinic Acid, and Bevacizumab. The goal is to see how well ABBV-400 works and to monitor any side effects that participants might experience. The study will include about 206 participants at 65 sites around the world and will last approximately three years.

To be eligible for this trial, participants must have a confirmed diagnosis of unresectable metastatic colorectal cancer and measurable disease. However, certain individuals, such as those with specific genetic mutations or who have recently received other cancer treatments, may not qualify. Participants can expect to visit their treatment center regularly for medical assessments, blood tests, and questionnaires to keep track of their health and any side effects from the treatment. It's important to note that the treatment might require more frequent visits and monitoring compared to standard care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC).
• • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• • Progressed on only one first-line (1L) systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy.
• Exclusion Criteria:
• • Harbor the BRAF V600E mutation.
• • dMMR+/MSI-H.
• • Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400.