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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
TAS-120 20 mg tablets, oral; once daily
400 mg once every 6-week-cycle, via IV infusion.
80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy
University of California Los Angeles UCLA - Cancer Care - Santa Monica
Santa Monica, California, United States
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
Time frame: 12 months
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
6-month PFS rate
defined as percentage of patients without disease progression within 6 months of enrollment
Time frame: 12 months
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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.
150 mg/m\^2 Q2W as part of mFOLFIRINOX chemotherapy.
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
...and 12 more locations