Future

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

8 Dec 2025 → ongoing

Decision date (initial)

2025-08-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

BeiGene Switzerland GmbH · Taiho Oncology Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

Specific for FUTURE-001: To evaluate the efficacy of futibatinib plus tislelizumab and chemotherapy in 1st-line-treatment of patients with colorectal cancer.

Secondary objectives 1

1. Specific for FUTURE-001: To evaluate further efficacy as well as to assess safety and impact on the quality of life of futibatinib plus tislelizumab and chemotherapy in treatment-1st line patients with colorectal cancer.

Conditions and MedDRA coding

Colorectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

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: 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
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.

Exclusion criteria 24

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. Patients has history and/or current evidence of any of the following disorders: a) Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the investigator b) 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: a) Major surgery within 4 weeks (surgical incision should be fully healed) b) Radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks c) Any investigational drug within 4 weeks
18. Female patients, who are pregnant or breast feeding or planning to become pregnant within up to 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 (> 10 mg/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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 5

1. Duration of response (DoR)
2. Progression free survival (PFS) according to RECIST v1.1
3. Overall survival (OS)
4. Safety
5. Quality of life using EORTC QLQ-C30

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Sponsor organisation

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Address

Steinbacher Hohl 2-26, Praunheim Praunheim

City

Frankfurt Am Main

Postcode

60488

Country

Germany

Scientific contact point

Organisation

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Contact name

Prof. Dr. Thorsten Götze

Public contact point

Organisation

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Contact name

Prof. Dr. Thorsten Götze

Third parties 4

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications