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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

July 13, 2023

Primary Completion Date

March 31, 2026

Study Completion Date

January 31, 2027

Conditions
Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal CancerEsophageal AdenocarcinomaEsophageal Squamous Cell CancerSiewert Type 1 GEJ CancerPancreatic Cancer
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.

Trial Locations (22)

10016

NYU Langone, New York

14203

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

19044

Alliance Cancer Specialists, Horsham

22031

Inova Schar Cancer Institute, Fairfax

24014

Blue Ridge Cancer Care, Roanoke

28041

Hospital Universitario 12 de Octubre, Madrid

33140

Mount Sinai Comprehensive Cancer Center, Miami Beach

33612

Moffitt Cancer Center and Research Institute, Tampa

37232

Vanderbilt University Medical Center, Nashville

44718

Gabrail Cancer Center Research LLC, Canton

48202

Henry Ford Health System, Detroit

54601

Gundersen Lutheran Health System, La Crosse

55131

Universitaetsmedizin Mainz, Mainz

59037

Centre Hospitalier Regional Universitaire de Lille, Lille

60488

Krankenhaus Nordwest gGmbH, Frankfurt

75216

Dallas VA Medical Center, Dallas

80218

Rocky Mountain Cancer Centers Midtown, Denver

86000

Centre Hospitalier Regional Universitaire Poitiers, Poitiers

90404

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

98101

Virginia Mason Medical Center, Seattle

08056

The Minniti Center - Medical Oncology and Hematology, Mickleton

08035

Hospital Universitari Vall d'Hebron, Barcelona

All Listed Sponsors
lead

Taiho Oncology, Inc.

INDUSTRY