Clinical Trial

Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer

Recruiting Phase 2
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-09-06; most recent amendment 2026-01-29.
Status change: Not Yet Recruiting → Recruiting 2023-09-21
Trial Details
NCT Number NCT05534646
Lead Sponsor Edwin Posadas, MD
Collaborators: Enviro Therapeutics, Inc.
Conditions Castration-resistant Prostate Cancer
Enrollment 100 participants
Start Date 2023-12-27
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-02