Futibatinib for Cancer

Recruiting at 69 trial locations

Overseen By Jill Kremer, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Taiho Oncology, Inc.

Must not be taking: FGFR inhibitors

Disqualifiers: Calcium-phosphorus disorders, Ectopic calcification, Retinal/corneal disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 6 months

115 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing futibatinib, an oral medication, in patients with specific genetic changes in their cancer. It aims to block proteins that help cancer grow, targeting those who may not respond well to typical treatments. Futibatinib has shown selective antitumor activity in various tumors.

Eligibility Criteria

This trial is for adults with advanced solid tumors, gastric or gastro-esophageal junction cancer, and certain blood cancers that have specific FGFR genetic changes. Participants must have measurable disease and should have tried standard treatments without success. They can't join if they've had prior FGFR inhibitor treatment or significant eye, mineral balance disorders, or unstable brain metastases.

Inclusion Criteria

I have had at least 2 treatments for my advanced cancer.

I cannot have a stem cell transplant or it didn't work for me, and no other treatments are suitable.

My stomach or GEJ cancer worsened after the last treatment.

Exclusion Criteria

My brain metastases are either untreated or not stable for over a month.

You have a medical condition related to the balance of calcium and phosphorus in your body that the doctor considers important.

I have been treated with an FGFR inhibitor before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive futibatinib at an oral dose of 20 mg once a day on a continuous 28-day cycle until disease progression or unacceptable toxicity

Approximately 6 months

Follow-up

Participants are monitored for survival every 12 weeks until survival events have been reported for 75% of enrolled patients or the study is terminated

12 months

Treatment Details

Interventions

• Futibatinib

Trial Overview The study tests the drug Futibatinib's effectiveness and safety in three groups: those with solid tumors (excluding primary brain tumors) having FGFR1-4 rearrangements; those with gastric cancer with FGFR2 amplification; and blood cancers with FGFR1 rearrangements.

Participant Groups

Group I: Futibatinib (Cohort C) Experimental Treatment 1 Intervention

Myeloid or lymphoid neoplasm harboring FGFR1 rearrangement

Group II: Futibatinib (Cohort B) Experimental Treatment 1 Intervention

Advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification

Group III: Futibatinib (Cohort A) Experimental Treatment 1 Intervention

Advanced or metastatic solid tumors harboring FGFR1-4 rearrangements

Futibatinib is already approved in United States for the following indications:

Approved in United States as Lytgobi for:

• Treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements

Who Is Running the Clinical Trial?

Taiho Oncology, Inc.

Lead Sponsor

Trials

79

Recruited

12,700+

Tim Whitten

Taiho Oncology, Inc.

Chief Executive Officer since 2018

MBA and Pharmacy degree

Harold Keer

Taiho Oncology, Inc.

Chief Medical Officer

MD, PhD