NCT06722183

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

FUTURE Platform Trial - A Phase II Platform Trial of Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The FUTURE trial is a prospective, multicentre, exploratory, open-label phase II platform trial. Its goal is to evaluate the efficacy, feasibility and safety of futibatinib combined with immunotherapeutic, targeted or chemotherapeutic agents in colorectal and other solid tumors and to additionally identify biomarkers that correlate with clinical outcome.

Detailed description

For the FUTURE-001 cohort: All enrolled patients will take mFOLFOX 85 mg/m2 oxalipla n, 200 mg/m2 calcium folinate, 400 mg/m2 5-fluorouracil as bolus dose and 2400 mg/m2 5-fluorouracil as 48 h-infusion as standard chemotherapy on day 1, 15 and 29 of a 6-week cycle. Additionally, tislelizumab (i.v., 200 mg) is applied on day 1 and day 22. Futibatinib will be taken orally, once daily, continously. All patients enrolled will receive the study treatment for up to 12 months or until disease progression, unacceptable toxicity or patient's request or investigator's decision, whatever occurs first. The primary objective is to evaluate the efficacy (primary endpoint: Overall Response Rate ORR, complete response + partial response) of futibatinib plus tislelizumab and chemotherapy in 1st-linetreatment of patients with colorectal cancer. The secondary objective is to evaluate further efficacy (duration of response (DoR, Progression-free survival (PFS), overall survival (OS)) as well as to assess safety and impact on the patients quality of life. Additionally, a correlation analysis between selected molecular parameters and clinical data to identify molecular biomarkers predictive for clinical outcome will be performed. 33 patients will be enrolled in this trial.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Futibatinib orally administered	Futibatinib will be administered 20mg orally, once daily, continously
DRUG	Tislelizumab (i.v. 200mg)	Tislelizumab (i.v. 200mg) will be administered on day 1 and day 22 of a 6-week cycle

Timeline

• Start date: 2025-12-16
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2024-12-09
• Last updated: 2025-12-24

Locations

10 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study