NCT05945823

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with locally advanced, unresectable or metastatic esophageal cancer (EC) or pancreatic ductal adenocarcinoma (PDAC) will receive futibatinib in combination with pembrolizumab plus standard of care (SOC) chemotherapy. Patients with EC will receive Investigator choice of chemotherapy (FP or mFOLFOX6), patients with PDAC will receive mFOLFIRINOX. Subjects will receive futibatinib in combination with pembrolizumab plus standard of care (SOC) chemotherapy during induction phase of the study and will continue on futibatinib in combination with pembrolizumab in consolidation phase.

Conditions

• Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer
• Esophageal Adenocarcinoma
• Esophageal Squamous Cell Cancer
• Siewert Type 1 GEJ Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-13
• Primary completion: 2026-01-28
• Completion: 2027-01-01
• First posted: 2023-07-14
• Last updated: 2026-04-09

Locations

22 sites across 4 countries: United States, France, Germany, Spain

Regulatory

• FDA-regulated drug study