Clinical trial NCT05945823: Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
Official title: A Phase 2 Study of Futibatinib in Combination With PD-1 Antibody-based Standard of Care Therapy in Patients With Solid Tumors.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer
Esophageal Adenocarcinoma
Esophageal Squamous Cell Cancer
Siewert Type 1 GEJ Cancer
Pancreatic Cancer
Keywords: Futibatinib
Advanced esophageal cancer
Esophageal cancer
TAS-120
Immunotherapy
Esophageal squamous cell cancer (ESCC)
GEJ cancer
pancreatic ductal adenocarcinoma
pancreatic cancer
Lead sponsor: Taiho Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-14
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ORR by investigator assessment
timeFrame: 12 months
Secondary outcomes:
measure: Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0
timeFrame: 12 months
measure: DoR per investigator assessment
timeFrame: 12 months
measure: DCR per investigator assessment
timeFrame: 12 months
measure: PFS per investigator assessment
timeFrame: 12 months
measure: 6-month PFS rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: University of California Los Angeles UCLA - Cancer Care - Santa Monica
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers Midtown
state: Colorado
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center and Research Institute
state: Florida
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Mickleton
country: United States
facility: The Minniti Center - Medical Oncology and Hematology
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI))
state: New York
city: New York
country: United States
facility: NYU Langone
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center Research LLC
state: Ohio
city: Horsham
country: United States
facility: Alliance Cancer Specialists
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: La Crosse
country: United States
facility: Gundersen Lutheran Health System
state: Wisconsin
city: Lille Cedex
country: France
facility: Centre Hospitalier Regional Universitaire de Lille
city: Poitiers
country: France
facility: Centre Hospitalier Regional Universitaire Poitiers
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest gGmbH
city: Mainz
country: Germany
facility: Universitaetsmedizin Mainz
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
References: