Open Actively Recruiting

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

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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
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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
Contact
CHRISTOPHER LIM
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT05945823
For detailed technical eligibility, visit ClinicalTrials.gov.