A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer

Launched by ABBVIE · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for adults with metastatic colorectal cancer (mCRC), which is cancer that has spread to other parts of the body. The study is testing an investigational drug called telisotuzumab adizutecan when given with standard chemotherapy drugs and other medications. The purpose is to find out if this combination is safe and effective for patients. The trial will involve two stages: first, researchers will gradually increase the dose of telisotuzumab adizutecan to find a safe and effective level, and then participants will be divided into groups to receive different treatment combinations.

To be eligible for the trial, participants should be adults with a specific performance status (meaning they can carry out normal activities with little difficulty) and have measurable disease according to certain guidelines. Participants can expect regular visits to the hospital or clinic for treatment and check-ups, where their health will be closely monitored through exams and tests. This trial may require more visits and tests compared to standard care, but it aims to provide new options for those affected by this challenging disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• • Laboratory values meeting the criteria within the protocol.
• • Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.
• Exclusion Criteria:
• • Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and/or any topoisomerase inhibitor(s) (e.g., irinotecan).
• • History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.