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Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
Sponsor: Taiho Oncology, Inc.
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
Conditions
Interventions
Futibatinib
TAS-120 20 mg tablets, oral; once daily
Pembrolizumab
400 mg once every 6-week-cycle, via IV infusion.
Cisplatin
80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy
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.
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.
Leucovorin
400 mg/m\^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy.
Levoleucovorin
200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
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