Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities
NCT ID: NCT06722183
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
33 participants
INTERVENTIONAL
2025-12-16
2028-03-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Futibatinib plus tislelizumab plus 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 (SOC chemotherapy)
Futibatinib orally administered
Futibatinib will be administered 20mg orally, once daily, continously
Tislelizumab (i.v. 200mg)
Tislelizumab (i.v. 200mg) will be administered on day 1 and day 22 of a 6-week cycle
Interventions
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Futibatinib orally administered
Futibatinib will be administered 20mg orally, once daily, continously
Tislelizumab (i.v. 200mg)
Tislelizumab (i.v. 200mg) will be administered on day 1 and day 22 of a 6-week cycle
Eligibility Criteria
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Inclusion Criteria
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:
1. ANC \> 1,500 cells/μL without the use of hematopoietic growth factors
2. Platelet count ≥ 100 x 109/L (\>100,000 per mm3)
3. Hemoglobin ≥ 9 g/dL, transfusion allowed
4. Serum total bilirubin ≤ 1.5x institutional upper normal limit (ULN) (or \< 2 x ULN in case of liver involvement or Gilbert's disease)
5. AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN without existing liver metastases, or ≤ 5 x UNL in the presence of liver metastases; AP ≤ 5 x ULN
6. Patients not receiving therapeutic anticoagulation must have an INR ≤ 1.5 ULN and aPTT ≤ 1.5 ULN. The use of full dose anticoagulants is allowed as long as the INR or PTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least three weeks at the time of inclusion
7. Serum Creatinine ≤ 1.5 x ULN and a calculated creatinine clearance rate ≥ 50 mL /min
8. Patient has serum calcium and phosphate levels within normal range.
9. Female patients of childbearing potential or male patients with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and in FUTURE-001 for at least 1 week after last dose of futibatinib, 6 months after the last dose of chemotherapy or 4 months after last dose of tislelizumab, whatever is later. Male patients should refrain from sperm donation/ cryopreservation throughout this period and male patients with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy. Female patients of child-bearing potential must have a negative pregnancy test within the last 7 days prior to the start of trial therapy.
10. Patient is willing and able to comply with the protocol (including contraceptive measures) for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
* There is no data that indicates a specific gender distribution. Therefore, patients are included regardless of their gender.
Exclusion Criteria
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).
7. Patient has a stage B cirrhosis according to Child-Pugh criteria (or worse) or cirrhosis (of any grade) with a history of hepatic encephalopathy or clinically significant ascites resulting from cirrhosis. Clinically significant ascites is defined as ascites resulting from cirrhosis requiring diuretics or paracentesis.
8. Patient has known allergic / hypersensitive reactions to at least one of the treatment components.
9. Patient shows a ≥ grade 2 neuropathy
10. Patient takes St. Johns Wort within 6 weeks prior to initiation of study treatment
11. Patient has evidence of or any ongoing ophthalmological disorders. including but not limited to, central serous retinopathy, macular/retinal degeneration, diabetic retinopathy, and previous retinal detachment
12. Patient has other serious illnesses or medical ailments within the last 12 months prior to the start of the study.
13. Patient has a known presence of an active, uncontrollable infection.
14. Patient has active disseminated intravascular coagulation.
15. Patient has any other serious concomitant or medical condition that, in the opinion of the investigator, presents a high risk of complications to the patient or reduces the likelihood of clinical effect.
16. Patient participated in another interventional clinical study within 28 days prior to study enrollment or participation in a clinical study at the same time as this study, unless it is an observational/ non-interventional study or during the follow-up period of an interventional study.
17. Patient received treatment with any of the following within the specified time frame prior to the first dose of study treatment:
1. Major surgery within 4 weeks (surgical incision should be fully healed)
2. Radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks
3. Any investigational drug within 4 weeks
18. Female patients, who are pregnant or breast feeding or planning to become pregnant within 6 months after the end of treatment. Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study treatment
19. Specific for FUTURE-001: Patient received prior treatment with PD-(L)1 or CTLA-4 targeted treatment
20. Specific for FUTURE-001: Patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis , hyperthyroidism; patients with vitiligo; asthma that has been completely remitted in childhood and does not require any intervention in adulthood can be included; patients with asthma requiring medical intervention with bronchodilators cannot be included)
21. Specific for FUTURE-001: Patient has immune deficiency or receives systemic steroid hormone therapy (\> 10mg/day prednisone or other equivalents), or other form of immunosuppressive therapy within 2 weeks prior treatment initiation
22. Specific for FUTURE-001: Patient has history of uncontrolled infection with human deficiency virus (HIV) or chronic infection with hepatitis B or C virus (HBV, HCV)
23. Specific for FUTURE-001: Patient has received a solid organ transplantation
24. Specific for FUTURE-001: Patient has history of interstitial lung disease
18 Years
ALL
No
Sponsors
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Universitätsmedizin Mainz, I. Medizinische Klinik, Forschungslabor Prof. Möhler
UNKNOWN
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
OTHER
Responsible Party
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Principal Investigators
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Salah Al-Batran, Prof. Dr.
Role: STUDY_DIRECTOR
Institut für Klinische Krebsforschung IKF GmbH
Thorsten O. Götze, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Institute of Clinical Cancer Research, UCT - University Cancer Center Frankfurt Krankenhaus Nordwest
Markus Möhler, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Johannes Gutenberg-University Clinic Mainz
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Ludwig Fischer von Weikersthal, Dr.
Role: primary
Dominik P Modest, Prof.
Role: primary
Christoph Roderburg, Prof.
Role: primary
Christian Müller, Dr.
Role: primary
Thorsten O. Götze, Prof. Dr.
Role: primary
Alexander Stein, Prof.
Role: primary
Markus Möhler, Prof.
Role: primary
Sylvie Lorenzen, Prof.
Role: primary
Tobias Dechow, Prof.
Role: primary
Stephan Kanzler, Prof.
Role: primary
Other Identifiers
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2024-517573-24-00
Identifier Type: CTIS
Identifier Source: secondary_id
FUTURE
Identifier Type: -
Identifier Source: org_study_id