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FUTURE Platform Trial: Futibatinib + (Chemo)Immunotherapy in Colorectal Cancer
NCT06722183Phase 2
Key facts
- Status
- Recruiting
- Start
- Dec 2025
- Primary completion
- Mar 2028
- Countries
- 1
- Modality
- Reversible Covalent Inhibitors, Allosteric Modulators, Orthosteric Ligands
- Drugs
- futibatinib
- Conditions
- colorectal cancer (CRC)
01
Overview
Phase 2, open-label, single-arm trial of futibatinib in colorectal cancer (CRC), sponsored by Institut für Klinische Krebsforschung. Primary endpoint: Overall Response Rate up to 27 months. Started Dec 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Futibatinib + Tislelizumab + mFOLFOX
Futibatinib 20 mg orally, once daily, continuously, plus tislelizumab (i.v., 200 mg) on day 1 and day 22 at each 6-week cycle and mFOLFOX
03
Who it enrols
Adult patients with unresectable and/or metastatic colorectal adenocarcinoma with known RAS, BRAF, and MSI status, who have not received prior palliative therapy (1st line). Must have ECOG <= 1 and adequate organ function. Excludes patients with prior FGFR, PD-(L)1, or CTLA-4 targeted therapy, active autoimmune disease, or significant liver disease.
04
Endpoints
Primary
Overall Response Rate
Secondary
Duration of Response
Progression-Free Survival
Overall Survival
Adverse Events
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