Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
NCT ID: NCT05945823
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
53 participants
INTERVENTIONAL
2023-07-13
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
Futibatinib
TAS-120 20 mg tablets, oral; once daily
Pembrolizumab
400 mg once every 6-week-cycle, via IV infusion.
Cisplatin
80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy
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.
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.
Leucovorin
400 mg/m\^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy.
Levoleucovorin
200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
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) .
Futibatinib
TAS-120 20 mg tablets, oral; once daily
Pembrolizumab
400 mg once every 6-week-cycle, via IV infusion.
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.
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.
Leucovorin
400 mg/m\^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy.
Levoleucovorin
200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Irinotecan
150 mg/m\^2 Q2W as part of mFOLFIRINOX chemotherapy.
Interventions
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Futibatinib
TAS-120 20 mg tablets, oral; once daily
Pembrolizumab
400 mg once every 6-week-cycle, via IV infusion.
Cisplatin
80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy
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.
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.
Leucovorin
400 mg/m\^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy.
Levoleucovorin
200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Irinotecan
150 mg/m\^2 Q2W as part of mFOLFIRINOX chemotherapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Taiho Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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University of California Los Angeles UCLA - Cancer Care - Santa Monica
Santa Monica, California, United States
Rocky Mountain Cancer Centers Midtown
Denver, Colorado, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Henry Ford Health System
Detroit, Michigan, United States
The Minniti Center - Medical Oncology and Hematology
Mickleton, New Jersey, United States
Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI))
Buffalo, New York, United States
NYU Langone
New York, New York, United States
Gabrail Cancer Center Research LLC
Canton, Ohio, United States
Alliance Cancer Specialists
Horsham, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Dallas VA Medical Center
Dallas, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Blue Ridge Cancer Care
Roanoke, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Gundersen Lutheran Health System
La Crosse, Wisconsin, United States
Centre Hospitalier Regional Universitaire de Lille
Lille, , France
Centre Hospitalier Regional Universitaire Poitiers
Poitiers, , France
Krankenhaus Nordwest gGmbH
Frankfurt, , Germany
Universitaetsmedizin Mainz
Mainz, , Germany
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Countries
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Other Identifiers
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TAS-120-206
Identifier Type: -
Identifier Source: org_study_id