RecruitingPhase 2NCT06722183

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


Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrollment

33 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing futibatinib — a targeted drug that blocks an abnormal protein called FGFR — in combination with other cancer treatments for patients with colorectal cancer and certain other solid tumors. The combination also includes immunotherapy and potentially chemotherapy. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with colorectal adenocarcinoma (colon or rectal cancer) confirmed by biopsy that is unresectable and/or metastatic - Your tumor has been tested for RAS, BRAF, and MSI status - You have not received any prior treatment in the advanced/palliative setting (first-line patients only for the colorectal cohort) - You are in reasonably good physical condition (ECOG 0-1) - Your blood counts and organ function are adequate - You agree to participate in accompanying research (tissue and blood samples) **You may NOT be eligible if...** - You have active brain tumors - You have significant heart problems - You have active inflammatory lung disease - You have received prior chemotherapy or immunotherapy for this stage of disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFutibatinib orally administered

Futibatinib will be administered 20mg orally, once daily, continously

DRUGTislelizumab (i.v. 200mg)

Tislelizumab (i.v. 200mg) will be administered on day 1 and day 22 of a 6-week cycle


Locations(10)

Klinikum St. Marien Amberg

Amberg, Germany

Charité Campus Virchow Klinikum (CVK)

Berlin, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Kliniken Essen-Mitte

Essen, Germany

Krankenhaus Nordwest

Frankfurt am Main, Germany

Hope Hamburg

Hamburg, Germany

Universitätsmedizin Mainz

Mainz, Germany

Klinikum München rechts der Isar

München, Germany

MVZ für Hämatologie und Onkologie Ravensburg GmbH

Ravensburg, Germany

Leopoldina Krankenhaus Schweinfurt

Schweinfurt, Germany

View Full Details on ClinicalTrials.gov

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NCT06722183


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