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

NCT05945823 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-04-09

No results posted yet for this study

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.

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

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.

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-13
Primary Completion
2026-01-28
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05945823 on ClinicalTrials.gov