mCRPC Clinical Program

Clinical Programs

Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

Onvansertib in combination with abiraterone in patients who have developed initial resistance to abiraterone to improve disease control rate and progression-free survival.

Efficacy End Points

  • Primary: Proportion of patients achieving disease control after 12-weeks of treatment, as defined by lack of PSA progression (per PCWG3 criteria)
  • Secondary: Radiographic response (per RECIST v1.1); time to PSA progression
  • Exploratory: Target inhibition of PLK1 and relevant biomarkers correlated with patient response

Proof of Concept Criteria

  • 30% disease control rate after 12-weeks of treatment
  • ≥6 months median progression-free survival