Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
A Phase 2 Study of Futibatinib in Combination With PD-1 Antibody-based Standard of Care Therapy in Patients With Solid Tumors.
1 other identifier
interventional
53
4 countries
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2023
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2023
CompletedStudy Start
First participant enrolled
July 13, 2023
CompletedFirst Posted
Study publicly available on registry
July 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
ExpectedApril 9, 2026
April 1, 2026
2.5 years
July 6, 2023
April 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0
12 months
DoR per investigator assessment
12 months
DCR per investigator assessment
12 months
PFS per investigator assessment
12 months
6-month PFS rate
12 months
Study Arms (2)
Cohort A
EXPERIMENTALPatients 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).
Cohort B
EXPERIMENTALPatients 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) .
Interventions
80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy
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.
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.
400 mg/m\^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy.
200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
400 mg once every 6-week-cycle, via IV infusion.
Eligibility Criteria
You may qualify if:
- Is ≥18 years of age at the time of informed consent
- 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).
- Cohort B: Histologically or cytologically confirmed, locally advanced, unresectable or metastatic pancreatic ductal adenocarcinoma.
- No prior systemic treatment for locally advanced, unresectable or metastatic disease
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ function
- Able to take medications orally
You may not qualify if:
- Has locally advanced disease that is resectable or potentially curable with radiation therapy (as determined by local investigator).
- Has an adenocarcinoma histology and is eligible to receive approved targeted therapy (eg, HER-2 positive patients).
- 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.
- Has known additional malignancy that is progressing or requires active treatment.
- History or current evidence of calcium and phosphate homeostasis disorder
- Current evidence of clinically significant retinal disorder
- Pregnant or lactating female.
- Has known hypersensitivity or severe reaction to any of the study drugs or their excipients.
- Has a diagnosis of immunodeficiency.
- 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.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
- Has had an allogenic tissue/organ transplant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
University of California Los Angeles UCLA - Cancer Care - Santa Monica
Santa Monica, California, 90404, United States
Rocky Mountain Cancer Centers Midtown
Denver, Colorado, 80218, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
The Minniti Center - Medical Oncology and Hematology
Mickleton, New Jersey, 08056, United States
Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI))
Buffalo, New York, 14203, United States
NYU Langone
New York, New York, 10016, United States
Gabrail Cancer Center Research LLC
Canton, Ohio, 44718, United States
Alliance Cancer Specialists
Horsham, Pennsylvania, 19044, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Gundersen Lutheran Health System
La Crosse, Wisconsin, 54601, United States
Centre Hospitalier Regional Universitaire de Lille
Lille, 59037, France
Centre Hospitalier Regional Universitaire Poitiers
Poitiers, 86000, France
Krankenhaus Nordwest gGmbH
Frankfurt, 60488, Germany
Universitaetsmedizin Mainz
Mainz, 55131, Germany
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
July 6, 2023
First Posted
July 14, 2023
Study Start
July 13, 2023
Primary Completion
January 28, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share