Actively Recruiting
Phase 2 Study to Assess Safety and Effectiveness of Telisotuzumab Adizutecan Combined With Chemotherapy and Targeted Drugs in Adults With Metastatic Colorectal Cancer
Led by AbbVie · Updated on 2026-08-04
390
Participants Needed
59
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Metastatic colorectal cancer mCRC is a common type of cancer, especially in developed countries. This trial evaluates the safety and changes in disease activity when an investigational drug, telisotuzumab adizutecan, is given with standard chemotherapy regimens including oxaliplatin, fluorouracil 5FU, leucovorin LV, and targeted therapies bevacizumab or panitumumab. Researchers aim to determine tolerable and effective doses and compare these treatments in adult participants with mCRC. The study is divided into two stages. The first stage involves dose escalation where participants receive increasing intravenous doses of telisotuzumab adizutecan combined with either FOLFOX fluorouracil, leucovorin, oxaliplatin plus bevacizumab or 5FULV plus panitumumab until a tolerable and potentially effective dose is identified. In the second stage, participants are randomized into three groups to receive either one of two optimized doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FULV and panitumumab, or a comparator group receiving FOLFOX with bevacizumab or panitumumab. The study lasts about six years. Participants will attend regular visits at approved hospitals or clinics throughout the study. Researchers will monitor treatment effects through medical assessments, blood tests, symptom questionnaires, and tracking of side effects. Key outcomes include tumor response, adverse events, progression-free survival, duration of response, overall survival, and disease control. This comprehensive monitoring aims to evaluate both safety and effectiveness of the treatment combinations over the study period.
CONDITIONS
Brief Title
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
Research Team
A
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