Phase II Trial of Futibatinib Combined With Tislelizumab and Chemotherapy for First-Line Treatment of Colorectal Cancer and Other Solid Tumors

What this Trial Is About

Researchers are evaluating the combination of futibatinib with immunotherapy, targeted therapy, and chemotherapy in patients with colorectal cancer and other solid tumors. This exploratory, open-label phase II trial aims to assess how well these treatments work together, their feasibility, safety, and to identify biomarkers that may predict clinical outcomes. The study focuses on patients with advanced colorectal adenocarcinoma who have not received prior palliative treatment and includes a translational research component to analyze molecular factors. Participants in the FUTURE-001 cohort receive a regimen consisting of mFOLFOX chemotherapy given on days 1, 15, and 29 of a 6-week cycle, combined with tislelizumab administered intravenously on days 1 and 22. Futibatinib is taken orally once daily without interruption. Treatment continues for up to 12 months or until disease progression, unacceptable side effects, or withdrawal. The trial enrolls 33 patients to evaluate this combination. Throughout the study, patients undergo regular monitoring to assess tumor response using overall response rate as the primary measure, along with secondary measures including duration of response, progression-free survival, overall survival, and safety over up to 27 months. Blood tests, imaging studies, and quality of life assessments are conducted to track treatment effects and patient well-being. Adverse events are recorded for up to 30 days after the last dose or until another anti-cancer therapy starts.

Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities