Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
Status:
Not yet recruiting
Trial end date:
2025-11-01
Target enrollment:
Participant gender:
Summary
This is an open-label, multi-site study of apalutamide with carotuximab in patients who have
progressed on androgen receptor signaling inhibitor (ARSI) therapy. This study will begin
with a safety assessment in the first 10 subjects (part 1: Safety Lead-in). If the
combination is deemed safe, the trial will proceed to the Phase II stage. The purpose of this
study is to compare progression free survival (PFS) between patients receiving apalutamide
and apalutamide + carotuximab using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
and Prostate Cancer Working Group 3. The secondary objectives are to describe adverse events
related to the intervention, overall response rate (ORR), proportion of patients resistant to
apalutamide that benefit from the addition of carotuximab, and to determine the ORR,
radiographic PFS, and biochemical PFS in the overall population.