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

Prior treatment

• 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 had an allogenic tissue/organ transplant.

Other illness

• Has locally advanced disease that is resectable or potentially curable with radiation therapy (as determined by local investigator).
• Has known additional malignancy that is progressing or requires active treatment.
• Current evidence of clinically significant retinal disorder
• Has known hypersensitivity or severe reaction to any of the study drugs or their excipients.
• 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.

Lab values

• History or current evidence of calcium and phosphate homeostasis disorder

Other

• Pregnant or lactating female.
• Has a diagnosis of immunodeficiency.

• 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