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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Futibatinib — DRUG
  TAS-120 20 mg tablets, oral; once daily
• Pembrolizumab — DRUG
  400 mg once every 6-week-cycle, via IV infusion.
• Cisplatin — DRUG
  80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy
• 5-FU — DRUG
  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 — DRUG
  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 — DRUG
  400 mg/m\^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy.
• Levoleucovorin — DRUG
  200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
• Irinotecan — DRUG
  150 mg/m\^2 Q2W as part of mFOLFIRINOX chemotherapy.

Study Details

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.

Key Dates

Start date

Jul 13, 2023

Status verified

Apr 2026

Primary completion

Jan 28, 2026

Completion

Jan 31, 2027

Study Design

Enrollment

53 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A
  Patients with Esophageal cancer (Adenocarcinoma or Squamous cell cancer) will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy (FP or mFOLFOX6) for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase).
• Experimental: Cohort B
  Patients with PDAC will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus mFOLFIRINOX for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase) .

Primary Outcome Measure

ORR by investigator assessment [ Time Frame: 12 months ]

Locations (16)

Find similar trials in Santa Monica, CA

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