mPDAC Clinical Program

Clinical Programs

Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Onvansertib in combination with nanoliposomal irinotecan and 5-FU for second-line treatment of patients to improve response rates and progression-free survival over SoC alone.

Efficacy End Points

  • Primary: Objective response rate in patients who receive ≥28-days of treatment
  • Secondary: Duration of Response (DOR) and Overall Survival (OS)
  • Exploratory: Identification of biomarkers related to sensitivity and resistance to treatment using patient-derived organoids, blood samples, and archival tissue biopsies

Proof of Concept Criteria

  • 20% objective response rate
  • ≥6 months median progression-free survival