Phase 2 Futibatinib In Combination With PD-1 Antibody Based Standard Of Care In Solid Tumors

Study Overview

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

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.

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.

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

DRUG: Futibatinib
DRUG: Pembrolizumab
DRUG: Cisplatin
DRUG: 5-FU
DRUG: Oxaliplatin
DRUG: Leucovorin
DRUG: Levoleucovorin
DRUG: Irinotecan

TAS-120-206

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-07-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-09-03
First Submitted that Met QC Criteria 2023-07-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-09-04
First Posted (ESTIMATED) 2023-07-14	Results First Posted N/A	Last Verified 2025-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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	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^ 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.
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 pha	DRUG: Futibatinib TAS-120 20 mg tablets, oral; once daily DRUG: Pembrolizumab 400 mg once every 6-week-cycle, via IV infusion. 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^ 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.

Participant Group/Arm

Intervention/Treatment

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

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^

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.

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 pha

DRUG: Futibatinib

TAS-120 20 mg tablets, oral; once daily

DRUG: Pembrolizumab

400 mg once every 6-week-cycle, via IV infusion.

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^

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.

Primary Outcome Measures	Measure Description	Time Frame
ORR by investigator assessment	Defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on investigator assessment	12 months

Secondary Outcome Measures	Measure Description	Time Frame
Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0	Safety will be assessed based on reported AEs (including SAEs), graded by CTCAE V5.0., and dose modifications.	12 months
DoR per investigator assessment	defined as time from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first	12 months
DCR per investigator assessment	defined as percentage of patients who achieve complete response, partial response or stable disease per RECIST 1.1 by investigator assessment	12 months
PFS per investigator assessment	defined as the time from date of enrollment to the date of disease progression based on Investigator assessment of radiographic images or death, whichever occurs first	12 months
6-month PFS rate	defined as percentage of patients without disease progression within 6 months of enrollment	12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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Clinical Trial Record