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

Running, not enrolling · Phase 2

Conditions studied: Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer, Esophageal Adenocarcinoma, Esophageal Squamous Cell Cancer, Siewert Type 1 GEJ Cancer, Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT05945823

Run by

Taiho Oncology, Inc.

People needed

53

Starts

2023-07-13

Expected to finish

2027-01-01

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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