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

February 23, 2024 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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 2

Expanded Access

Approved 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 Locations

  • France
      • Lille Cedex, France, 59037
        • Not yet recruiting
        • Centre Hospitalier Regional Universitaire de Lille
        • Contact:
        • Principal Investigator:
          • Anne Plaquinn
      • Poitiers, France, 86000
        • Not yet recruiting
        • Centre Hospitalier Regional Universitaire Poitiers
        • Principal Investigator:
          • David Tougeron
        • Contact:
  • Germany
      • Frankfurt, Germany, 60488
        • Not yet recruiting
        • Krankenhaus Nordwest gGmbH
        • Principal Investigator:
          • Thorsten Goetze
        • Contact:
      • Mainz, Germany, 55131
  • Spain
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Marc Diez Garcia
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
        • Principal Investigator:
          • Carlos Jesus Gomez Martin
  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Not yet recruiting
        • University of California Los Angeles UCLA - Cancer Care - Santa Monica
        • Contact:
        • Principal Investigator:
          • Rosen Lee
    • Colorado
      • Denver, Colorado, United States, 80218
        • Not yet recruiting
        • Rocky Mountain Cancer Centers Midtown
        • Principal Investigator:
          • Allen Cohn
        • Contact:
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Not yet recruiting
        • Mount Sinai Comprehensive Cancer Center
        • Principal Investigator:
          • Mike Cusnir
        • Contact:
      • Tampa, Florida, United States, 33612
        • Not yet recruiting
        • Moffitt Cancer Center and Research Institute
        • Principal Investigator:
          • Rutika Mehta
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Not yet recruiting
        • Henry Ford Health System
        • Contact:
        • Principal Investigator:
          • Gazala Khan
    • New Jersey
      • Mickleton, New Jersey, United States, 08056
        • Recruiting
        • The Minniti Center - Medical Oncology and Hematology
        • Contact:
        • Principal Investigator:
          • Carl Minniti
    • New York
      • Buffalo, New York, United States, 14203
        • Not yet recruiting
        • Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI))
        • Principal Investigator:
          • Sarbajit Mukherjee
        • Contact:
      • New York, New York, United States, 10016
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Gabrail Cancer Center Research LLC
        • Principal Investigator:
          • Nashat Gabrail
        • Contact:
    • Pennsylvania
      • Horsham, Pennsylvania, United States, 19044
        • Not yet recruiting
        • Alliance Cancer Specialists
        • Principal Investigator:
          • Joseph Potz
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Michael Gibson
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75216
        • Not yet recruiting
        • Dallas VA Medical Center
        • Contact:
        • Principal Investigator:
          • David Wang
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Not yet recruiting
        • Inova Schar Cancer Institute
        • Principal Investigator:
          • Jasmine Huynh
        • Contact:
      • Roanoke, Virginia, United States, 24014
        • Not yet recruiting
        • Blue Ridge Cancer Care
        • Principal Investigator:
          • Mark Kochenderfer
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98101
        • Not yet recruiting
        • Virginia Mason Medical Center
        • Contact:
        • Principal Investigator:
          • Bruce Lin
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Health System
        • Principal Investigator:
          • Kurt Oettel
        • Contact:

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

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
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 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

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

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

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)

July 13, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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