RecruitingColorectal Cancer
Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
You may qualify if…
- ✓ 1. Patient\* provides signed informed consent.
- ✓ 2. Patient is ≥ 18 years at the time of given informed consent.
- ✓ 3. Patient has a histologically proven solid tumor:
- ✓ Specific for FUTURE-001: Histological or cytological confirmation of colorectal adenocarcinoma that is unresectable and/or metastatic with known RAS-, BRAF and MSI- status.
- ✓ 4. Specific for FUTURE-001: Patient must agree to participation in the accompanying translational research program.
- ✓ 5. Specific for FUTURE-001: Patient did not receive previous therapy in palliative setting (1st line situation).
- ✓ 6. Patient has ECOG Performance status ≤ 1.
- ✓ 7. Patient has adequate blood count, liver-enzymes, and renal function:
You may not qualify if…
- ✕ 1. Specific for FUTURE-001: Patient has curative colorectal cancer.
- ✕ 2. Patient received previous FGFR-addressed therapy with an FGFR inhibitor.
- ✕ 3. Patient has known presence of tumors other than the entity investigated in the respective cohort (FUTURE-001: colorectal cancer) or a secondary tumor other than squamous or basal cell carcinomas of the skin or in situ carcinomas of the cervix which have been effectively treated. The sponsor decides to include patients who have received curative treatment and have been disease-free for at least 5 years
- ✕ 4. Patient has known untreated or symptomatic CNS or leptomeningeal metastases.
- ✕ 5. Patient has history and/or current evidence of any of the following disorders:
- ✕ 1. Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the investigator
- ✕ 2. Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the investigator
- ✕ 6. Patient receives simultaneous, ongoing systemic immunotherapy, chemotherapy, or hormone anti-cancer therapy or any other anti-cancer treatment not described in the trial protocol (excluding palliative radiotherapy only for symptom control).
Source: ClinicalTrials.gov · NCT06722183 · last updated 2025-12-24