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

Phase 2 Active not recruiting 53 enrolled Taiho Oncology, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2023-07-13
Primary completion: 2026-01-28
Completion: 2027-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Futibatinib	Small molecule	20 mg	Oral
Background	Cisplatin	Other / unclassified	80 mg/m2	Intravenous
Background	Irinotecan	Small molecule	150 mg/m2	—
Background	Leucovorin	Small molecule	400 mg/m2	—
Background	Levoleucovorin	Unknown	200 mg/m2	—
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	2400 mg/m2	Intravenous
Background	Pembrolizumab	Monoclonal antibody	400 mg	Intravenous
Background	fluorouracil	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	4000 mg/m2	Intravenous

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

Summary

Timeline

Drugs

Indications