Colorectal CancerPhase 2FUTURENCT06722183
Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities
A Phase 2 study testing Futibatinib orally administered and Tislelizumab (i.v. 200mg) in people with Colorectal Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 10 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Futibatinib orally administered and Tislelizumab (i.v. 200mg)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 10 sitesGermany
- Study dates
- 16 Dec 2025to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
- 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
- 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.
- 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.
- 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.
Who cannot join
- 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
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- 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.
- Patient has active disseminated intravascular coagulation.
- 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.
- 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.
- Patient received treatment with any of the following within the specified time frame prior to the first dose of study treatment:
- Major surgery within 4 weeks (surgical incision should be fully healed)
- Radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks
- Any investigational drug within 4 weeks
- 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
- Specific for FUTURE-001: Patient received prior treatment with PD-(L)1 or CTLA-4 targeted treatment
- 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)
- 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
- 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)
- Specific for FUTURE-001: Patient has received a solid organ transplantation
- Specific for FUTURE-001: Patient has history of interstitial lung disease
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Germany10 sites, 10 recruiting
- Not yet recruiting
Klinikum St. Marien Amberg
Amberg
Ludwig Fischer von Weikersthal, Dr.
- Not yet recruiting
Charité Campus Virchow Klinikum (CVK)
Berlin
Dominik P Modest, Prof.
- Recruiting
Universitätsklinikum Düsseldorf
Düsseldorf
Christoph Roderburg, Prof.
- Recruiting
Kliniken Essen-Mitte
Essen
Christian Müller, Dr.
- Recruiting
Krankenhaus Nordwest
Frankfurt am Main, 60488
Thorsten O. Götze, Prof. Dr.
- Recruiting
Hope Hamburg
Hamburg
Alexander Stein, Prof.
- Not yet recruiting
Universitätsmedizin Mainz
Mainz
Markus Möhler, Prof.
- Recruiting
Klinikum München rechts der Isar
München
Sylvie Lorenzen, Prof.
- Not yet recruiting
MVZ für Hämatologie und Onkologie Ravensburg GmbH
Ravensburg, 88212
Tobias Dechow, Prof.
- Recruiting
Leopoldina Krankenhaus Schweinfurt
Schweinfurt
Stephan Kanzler, Prof.
About this study
Official title: FUTURE Platform Trial - A Phase II Platform Trial of Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities
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.
Read the detailed description
For the FUTURE-001 cohort:
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
- Colorectal Cancer
- Being tested
- Futibatinib orally administered, Tislelizumab (i.v. 200mg)
- Keywords
- platform trial, colorectal cancer, futibatinib, phase II
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Futibatinib orally administeredDrug
Futibatinib will be administered 20mg orally, once daily, continously
Tislelizumab (i.v. 200mg)Drug
Tislelizumab (i.v. 200mg) will be administered on day 1 and day 22 of a 6-week cycle
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Futibatinib orally administered; Drug: Tislelizumab (i.v. 200mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 27 months
Secondary outcomes (4)
Duration of Response (DoR)
(DoR), defined as time from response initiation (when either CR or PR is first determined) to date of progression or death to any cause
Measured: up to 27 months
Progression-free survival (PFS) according to RECIST v1.1
defined as time from date of enrollment to date of progression acc. to RECIST v1.1 or death due to any cause
Measured: every 8 weeks until disease progression, up to 27 months
Overall Survival (OS)
time from date of enrollment date of death due to any cause
Measured: up to 27 months
Safety
assessment of safety of the treatment as determined by the incidence, nature, causality, frequency, timing and severity of adverse events using NCI CTCAE 5.0
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start16 Dec 2025 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsmedizin Mainz, I. Medizinische Klinik, Forschungslabor Prof. Möhler
- Responsible party
- Sponsor
- Investigators
- Salah Al-Batran, Prof. Dr., Study director, Institut für Klinische Krebsforschung IKF GmbHThorsten O. Götze, Prof. Dr., Principal investigator, Institute of Clinical Cancer Research, UCT - University Cancer Center Frankfurt Krankenhaus NordwestMarkus Möhler, Prof. Dr., Principal investigator, Johannes Gutenberg-University Clinic Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722183
- Sponsor's protocol ID
- FUTURE
- Other IDs
- 2024-517573-24-00
- Acronym
- FUTURE
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FUTURE Platform Trial - A Phase II Platform Trial of Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities
- ClinicalTrials.gov ID
- NCT06722183
- Acronym / sponsor ID
- FUTURE / FUTURE
- Conditions
- Colorectal Cancer
- Keywords
- platform trial, colorectal cancer, futibatinib, phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestUniversity, hospital or other
- Collaborators
- Universitätsmedizin Mainz, I. Medizinische Klinik, Forschungslabor Prof. Möhler
- Study start
- 16 Dec 2025 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For the FUTURE-001 cohort:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Futibatinib plus tislelizumab plus mFOLFOX | Experimental | Drug: Futibatinib orally administered, Drug: Tislelizumab (i.v. 200mg)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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: 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).
Key exclusion criteria (29 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Futibatinib orally administeredFutibatinib will be administered 20mg orally, once daily, continously | Drug | Futibatinib plus tislelizumab plus mFOLFOX |
| Tislelizumab (i.v. 200mg)Tislelizumab (i.v. 200mg) will be administered on day 1 and day 22 of a 6-week cycle | Drug | Futibatinib plus tislelizumab plus mFOLFOX |
Primary outcome
Overall Response Rate (ORR) according to RECIST v1.1
Time frame: up to 27 months
ORR, defined as rate of patient who achieved complete or partial response (CR+PR) according to RECIST v1.1 as best response
4 secondary outcomes
Duration of Response (DoR)
Time frame: up to 27 months
Progression-free survival (PFS) according to RECIST v1.1
Time frame: every 8 weeks until disease progression, up to 27 months
Overall Survival (OS)
Time frame: up to 27 months
Safety
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salah Al-Batran, Prof. Dr. study director
Institut für Klinische Krebsforschung IKF GmbH
Thorsten O. Götze, Prof. Dr. principal investigator
Institute of Clinical Cancer Research, UCT - University Cancer Center Frankfurt Krankenhaus Nordwest
Markus Möhler, Prof. Dr. principal investigator
Johannes Gutenberg-University Clinic Mainz
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Futibatinib orally administered and Tislelizumab (i.v. 200mg) in people with Colorectal Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 10 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thorsten O. Götze, Prof. Dr. (0049 69 7601 ext. 3788, future@ikf-khnw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) according to RECIST v1.1 (time frame: up to 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.