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