Open
Actively Recruiting
Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
About
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
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Study Stats
Protocol No.
23-001422
Category
Esophageal Cancer
Principal Investigator
Contact
Location
- UCLA Santa Monica