Actively Recruiting
Phase IbII Study of Nelmastobart with TrifluridineTipiracil and Bevacizumab for Adults with Metastatic or Recurrent Colorectal Cancer Resistant to Oxaliplatin and Irinotecan Chemotherapy
Led by STCube, Inc. · Updated on 2025-07-11
52
Participants Needed
5
Research Sites
65 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying metastatic or recurrent colorectal cancer patients who have resistance or intolerance to standard chemotherapy based on oxaliplatin and irinotecan. This multi-center, open-label Phase IbII trial evaluates the safety, how the body processes, and the effectiveness of nelmastobart combined with trifluridinetipiracil and bevacizumab. The study also aims to find the maximum tolerated dose and recommended dose for further study, especially in patients positive for BTN1A1. Participants receive nelmastobart together with fixed doses of bevacizumab and varying doses of trifluridinetipiracil, which will be reduced in steps from 35 mgm to 25 mgm to determine the best dose. The study includes a single treatment group and looks at dose-limiting toxicities over up to 6 months, with longer-term follow-up for up to 2 years on progression-free survival and other outcomes. During the study, patients will be monitored for side effects and treatment effects using scans, blood tests, and clinical evaluations. Researchers will measure how long the cancer remains stable, survival rates, response rates, and drug levels in the blood. Safety and tolerability will be assessed throughout the treatment and follow-up periods, which may last up to 2 years after starting therapy.
CONDITIONS
Brief Title
Nelmastobart in Combination With Trifluridine/ Tipiracil and Bevacizumab in Metastatic/ Recurrent Colorectal Cancer
Research Team
H
Hyunju Yoo
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