MGC018 Versus Androgen Receptor Axis-targeted Therapy in Participants With Metastatic Castration Resistant Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2024-11-01

Summary

Study CP-MGC018-03 is a randomized, open-label, seamless, Phase 2/3 study. The study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT) and one prior taxane-containing regimen. ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior cabazitaxel regimen, but no other chemotherapy agents.

The Phase 2 stage will assess efficacy and tolerability of two MGC018 experimental arms (2.0 mg/kg Q4W and 2.7 mg/kg Q4W) compared to the control arm (abiraterone or enzalutamide). Approximately 150 participants will be randomized 1:1:1 in Phase 2 among the three study treatment arms (two MGC018 experimental arms and one control arm). An interim analysis will be performed to select the Phase 3 dose regimen for the MGC018 experimental arm for Phase 3 after approximately 150 participants enrolled in Phase 2 have been followed for at least 2 months (60 days).

The Phase 3 stage will assess efficacy of the selected dose regimen for the MGC018 experimental arm versus the control arm (abiraterone or enzalutamide). Approximately 270 additional participants will be randomized 1:1 between each study treatment arm in Phase 3 (one MGC018 experimental arm and the control arm).

• Phase: Phase 2/Phase 3

Details

• Lead Sponsor: MacroGenics