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Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
Trial Status: closed to accrual
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.
Inclusion Criteria
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
Exclusion Criteria
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05945823.
