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

NCT06722183 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: FUTURE2024-517573-24-00
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Colorectal Cancer

Keywords

platform trial; colorectal cancer; futibatinib; phase II

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) according to RECIST v1.1

  ORR, defined as rate of patient who achieved complete or partial response (CR+PR) according to RECIST v1.1 as best response

  up to 27 months

Secondary Outcomes (4)

• Duration of Response (DoR)

  up to 27 months

• Progression-free survival (PFS) according to RECIST v1.1

  every 8 weeks until disease progression, up to 27 months

• Overall Survival (OS)

  up to 27 months

• Safety

  AEs will be reported from start of trial treatment until 30 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first, up to 13 months

Other Outcomes (1)

• Identifcation of molecular biomarkers

  27 months

Study Arms (1)

Futibatinib plus tislelizumab plus mFOLFOX

EXPERIMENTAL

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)

Drug: Futibatinib orally administered; Drug: Tislelizumab (i.v. 200mg)

Interventions

Futibatinib orally administered DRUG

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

Futibatinib plus tislelizumab plus mFOLFOX

Tislelizumab (i.v. 200mg) DRUG

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

Futibatinib plus tislelizumab plus mFOLFOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient\* provides signed informed consent.
• Patient is ≥ 18 years at the time of given informed consent.
• 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.
• Specific for FUTURE-001: Patient must agree to participation in the accompanying translational research program.
• Specific for FUTURE-001: Patient did not receive previous therapy in palliative setting (1st line situation).
• Patient has ECOG Performance status ≤ 1.
• Patient has adequate blood count, liver-enzymes, and renal function:
• ANC \> 1,500 cells/μL without the use of hematopoietic growth factors
• Platelet count ≥ 100 x 109/L (\>100,000 per mm3)
• Hemoglobin ≥ 9 g/dL, transfusion allowed
• Serum total bilirubin ≤ 1.5x institutional upper normal limit (ULN) (or \< 2 x ULN in case of liver involvement or Gilbert's disease)
• 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
• Serum Creatinine ≤ 1.5 x ULN and a calculated creatinine clearance rate ≥ 50 mL /min
• Patient has serum calcium and phosphate levels within normal range.

You may not qualify if:

• Specific for FUTURE-001: Patient has curative colorectal cancer.
• Patient received previous FGFR-addressed therapy with an FGFR inhibitor.
• 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
• Patient has known untreated or symptomatic CNS or leptomeningeal metastases.
• Patient has history and/or current evidence of any of the following disorders:
• Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the investigator
• 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
• 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).
• 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.
• Patient has known allergic / hypersensitive reactions to at least one of the treatment components.
• Patient shows a ≥ grade 2 neuropathy
• Patient takes St. Johns Wort within 6 weeks prior to initiation of study treatment
• 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
• Patient has other serious illnesses or medical ailments within the last 12 months prior to the start of the study.
• Patient has a known presence of an active, uncontrollable infection.

Sponsors & Collaborators

• Universitätsmedizin Mainz, I. Medizinische Klinik, Forschungslabor Prof. Möhler: collaborator
• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: lead

Study Sites (10)

Klinikum St. Marien Amberg

Amberg, Germany

NOT YET RECRUITING

Charité Campus Virchow Klinikum (CVK)

Berlin, Germany

NOT YET RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

RECRUITING

Kliniken Essen-Mitte

Essen, Germany

RECRUITING

Krankenhaus Nordwest

Frankfurt am Main, 60488, Germany

RECRUITING

Hope Hamburg

Hamburg, Germany

RECRUITING

Universitätsmedizin Mainz

Mainz, Germany

NOT YET RECRUITING

Klinikum München rechts der Isar

München, Germany

RECRUITING

MVZ für Hämatologie und Onkologie Ravensburg GmbH

Ravensburg, 88212, Germany

NOT YET RECRUITING

Leopoldina Krankenhaus Schweinfurt

Schweinfurt, Germany

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Salah Al-Batran, Prof. Dr.

  Institut für Klinische Krebsforschung IKF GmbH

  STUDY DIRECTOR

• Thorsten O. Götze, Prof. Dr.

  Institute of Clinical Cancer Research, UCT - University Cancer Center Frankfurt Krankenhaus Nordwest

  PRINCIPAL INVESTIGATOR

• Markus Möhler, Prof. Dr.

  Johannes Gutenberg-University Clinic Mainz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thorsten O. Götze, Prof. Dr.

CONTACT

0049 69 7601; future@ikf-khnw.de

Annika S. Stürzebecher, Dr.

CONTACT

0049 69 5899 787; future@ikf-khnw.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: December 16, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (10)