Esophageal Cancer Clinical Trial
Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
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) will receive futibatinib in combination with pembrolizumab plus Investigator choice of chemotherapy (FP or mFOLFOX6). The study will begin with a safety lead-in period (Part 1), in which approximately 12 patients with advanced or metastatic esophageal cancer will be enrolled. In Part 2, approximately 14 EC patients will be enrolled and treated with the same treatment regimen.
Is ≥18 years of age at the time of informed consent
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).
No prior systemic treatment for locally advanced, unresectable or metastatic esophageal carcinoma.
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
Have documentation of immunotherapy-drugs-are-boosting-survival/" >PD-L1 CPS score.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate organ function
Able to take medications orally
Has locally advanced esophageal carcinoma 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.
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