Actively Recruiting
Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities
Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2025-12-24
33
Participants Needed
10
Research Sites
115 weeks
Total Duration
On this page
Sponsors
I
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead Sponsor
U
Universitätsmedizin Mainz, I. Medizinische Klinik, Forschungslabor Prof. Möhler
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient provides signed informed consent.
- Patient is 18 years or older at the time of consent.
- Histological or cytological confirmation of colorectal adenocarcinoma that is unresectable and/or metastatic with known RAS-, BRAF and MSI- status.
- Agreement to participate in the accompanying translational research program.
- No previous therapy received in the palliative 1st line setting.
- ECOG Performance status of 0 or 1.
- Adequate blood counts, liver enzymes, and kidney function as specified.
- Serum calcium and phosphate levels within normal range.
- Agreement to use effective contraceptive methods or abstain during treatment and specified periods after treatment.
- Willingness and ability to comply with the study protocol, including treatment and scheduled visits.
You will not qualify if you...
- Patient has curative colorectal cancer.
- Previous treatment with FGFR inhibitors.
- Presence of tumors other than colorectal cancer or secondary tumors except certain effectively treated skin or cervical carcinomas.
- Untreated or symptomatic central nervous system or leptomeningeal metastases.
- Clinically significant disorders affecting calcium-phosphorus balance or ectopic mineralization.
- Current systemic cancer treatments not described in the protocol.
- Significant liver cirrhosis or related complications.
- Known allergies to treatment components.
- Grade 2 or higher neuropathy.
- Use of St. John's Wort within 6 weeks before starting treatment.
- Ongoing or serious eye disorders.
- Serious illnesses within 12 months before study start.
- Active, uncontrolled infections or disseminated intravascular coagulation.
- Other serious medical conditions posing high risk.
- Participation in another interventional study within 28 days before enrollment.
- Recent major surgery or radiotherapy within specified timeframes.
- Pregnancy, breastfeeding, or planning pregnancy within 6 months after treatment.
- Prior treatment with PD-(L)1 or CTLA-4 targeted therapies.
- Active or history of autoimmune diseases.
- Immune deficiency or recent immunosuppressive therapy.
- History of HIV or chronic hepatitis B or C infection.
- History of solid organ transplantation.
- History of interstitial lung disease.
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Klinikum St. Marien Amberg
Amberg, Germany
Not Yet Recruiting
2
Charité Campus Virchow Klinikum (CVK)
Berlin, Germany
Not Yet Recruiting
3
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Actively Recruiting
4
Kliniken Essen-Mitte
Essen, Germany
Actively Recruiting
5
Krankenhaus Nordwest
Frankfurt am Main, Germany, 60488
Actively Recruiting
6
Hope Hamburg
Hamburg, Germany
Actively Recruiting
7
Universitätsmedizin Mainz
Mainz, Germany
Not Yet Recruiting
8
Klinikum München rechts der Isar
München, Germany
Actively Recruiting
9
MVZ für Hämatologie und Onkologie Ravensburg GmbH
Ravensburg, Germany, 88212
Not Yet Recruiting
10
Leopoldina Krankenhaus Schweinfurt
Schweinfurt, Germany
Actively Recruiting
Research Team
T
Thorsten O. Götze, Prof. Dr.
CONTACT
A
Annika S. Stürzebecher, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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