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ACTIVE NOT RECRUITING
NCT05945823
PHASE2

Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors

Sponsor: Taiho Oncology, Inc.

View on ClinicalTrials.gov

Summary

This is a nonrandomized, uncontrolled, open-label, multicenter Phase 2 study to evaluate the efficacy, safety, and tolerability of futibatinib in combination with PD-1 antibody-based SoC therapy in adult patients with solid tumors.

Official title: A Phase 2 Study of Futibatinib in Combination With PD-1 Antibody-based Standard of Care Therapy in Patients With Solid Tumors.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2023-07-13

Completion Date

2027-01

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

Futibatinib

TAS-120 20 mg tablets, oral; once daily

DRUG

Pembrolizumab

400 mg once every 6-week-cycle, via IV infusion.

DRUG

Cisplatin

80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy

DRUG

5-FU

4000 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m\^2 Q2W via bolus IV infusion followed by 2400 mg/m\^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy. 2400 mg/m\^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy. 2400 mg/m\^2 Q2W via continuous IV infusion, as part of mFOLFIRINOX chemotherapy.

DRUG

Oxaliplatin

85 mg/m\^2 Q2W via IV infusion, as part of mFOLFIRINOX or mFOLFOX6 chemotherapy. 2400 mg/m\^2 Q2W via continuous IV infusion, as part of mFOLFIRINOX chemotherapy.

DRUG

Leucovorin

400 mg/m\^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy.

DRUG

Levoleucovorin

200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.

DRUG

Irinotecan

150 mg/m\^2 Q2W as part of mFOLFIRINOX chemotherapy.

Locations (22)

University of California Los Angeles UCLA - Cancer Care - Santa Monica

Santa Monica, California, United States

Rocky Mountain Cancer Centers Midtown

Denver, Colorado, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Henry Ford Health System

Detroit, Michigan, United States

The Minniti Center - Medical Oncology and Hematology

Mickleton, New Jersey, United States

Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI))

Buffalo, New York, United States

NYU Langone

New York, New York, United States

Gabrail Cancer Center Research LLC

Canton, Ohio, United States

Alliance Cancer Specialists

Horsham, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Dallas VA Medical Center

Dallas, Texas, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Blue Ridge Cancer Care

Roanoke, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Gundersen Lutheran Health System

La Crosse, Wisconsin, United States

Centre Hospitalier Regional Universitaire de Lille

Lille, France

Centre Hospitalier Regional Universitaire Poitiers

Poitiers, France

Krankenhaus Nordwest gGmbH

Frankfurt, Germany

Universitaetsmedizin Mainz

Mainz, Germany

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain