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

August 31, 2026 updated by: Taiho Oncology, Inc.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Lille, France, 59037
        • Centre Hospitalier Régional Universitaire de Lille
      • Poitiers, France, 86000
        • Centre Hospitalier Regional Universitaire Poitiers
  • Germany
      • Frankfurt, Germany, 60488
        • Krankenhaus Nordwest gGmbH
      • Mainz, Germany, 55131
        • Universitaetsmedizin Mainz
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
  • United States
    • California
      • Santa Monica, California, United States, 90404
        • University of California Los Angeles UCLA - Cancer Care - Santa Monica
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers Midtown
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center and Research Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New Jersey
      • Mickleton, New Jersey, United States, 08056
        • The Minniti Center - Medical Oncology and Hematology
    • New York
      • Buffalo, New York, United States, 14203
        • Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI))
      • New York, New York, United States, 10016
        • NYU Langone
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center Research LLC
    • Pennsylvania
      • Horsham, Pennsylvania, United States, 19044
        • Alliance Cancer Specialists
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute
      • Roanoke, Virginia, United States, 24014
        • Blue Ridge Cancer Care
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Health System

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  1. Is ≥18 years of age at the time of informed consent
  2. Cohort A: Histologically or cytologically confirmed, locally advanced, unresectable or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the esophagogastric junction (EGJ).
  3. Cohort B: Histologically or cytologically confirmed, locally advanced, unresectable or metastatic pancreatic ductal adenocarcinoma.
  4. No prior systemic treatment for locally advanced, unresectable or metastatic disease
  5. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  7. Adequate organ function
  8. Able to take medications orally

Exclusion Criteria

  1. Has locally advanced disease that is resectable or potentially curable with radiation therapy (as determined by local investigator).
  2. Has an adenocarcinoma histology and is eligible to receive approved targeted therapy (eg, HER-2 positive patients).
  3. Has received prior treatment with an anti-PD-1/PD-L1 or FGF/FGFR targeting drug, or any other agent directed to stimulatory or co-stimulatory T-cell receptor.
  4. Has known additional malignancy that is progressing or requires active treatment.
  5. History or current evidence of calcium and phosphate homeostasis disorder
  6. Current evidence of clinically significant retinal disorder
  7. Pregnant or lactating female.
  8. Has known hypersensitivity or severe reaction to any of the study drugs or their excipients.
  9. Has a diagnosis of immunodeficiency.
  10. Has known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C antibody or RNA.
  11. Has an active autoimmune disease that has required systemic treatment in the past 2 years
  12. Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
  13. Has had an allogenic tissue/organ transplant.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Drug: Pembrolizumab
400 mg once every 6-week-cycle, via IV infusion.
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: Levoleucovorin
200 mg/m^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Other Names:
  • FUSILEV®
  • calcium levofolinate
  • levofolinic acid
Drug: Futibatinib
TAS-120 20 mg tablets, oral; once daily
Other Names:
  • TAS-120
Drug: Cisplatin
80 mg/m^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy
Other Names:
  • PLATINOL®
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.

Other Names:
  • ADRUCIL®
Drug: Leucovorin
400 mg/m^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy.
Other Names:
  • folinic acid
  • WELLCOVORIN®
  • calcium folinate
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.
Other Names:
  • ELOXATIN®
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) .
Drug: Pembrolizumab
400 mg once every 6-week-cycle, via IV infusion.
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: Levoleucovorin
200 mg/m^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Other Names:
  • FUSILEV®
  • calcium levofolinate
  • levofolinic acid
Drug: Futibatinib
TAS-120 20 mg tablets, oral; once daily
Other Names:
  • TAS-120
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.

Other Names:
  • ADRUCIL®
Drug: Leucovorin
400 mg/m^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy.
Other Names:
  • folinic acid
  • WELLCOVORIN®
  • calcium folinate
Drug: Irinotecan
150 mg/m^2 Q2W 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.
Other Names:
  • ELOXATIN®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ORR by investigator assessment
Time Frame: 12 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0
Time Frame: 12 months
Safety will be assessed based on reported AEs (including SAEs), graded by CTCAE V5.0., and dose modifications.
12 months
DoR per investigator assessment
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
defined as percentage of patients without disease progression within 6 months of enrollment
12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taiho Oncology, Inc.

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAS-120-206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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