OncoMatch/Clinical Trials/NCT05534646
Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
Is NCT05534646 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Apalutamide and Carotuximab for castration-resistant prostate cancer.
Treatment: Apalutamide · Carotuximab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Prior therapy
Must have received: AR targeted therapy (abiraterone, enzalutamide, darolutamide)
1 and can have up to 2 prior AR targeted therapy with the exception of apalutamide
Cannot have received: AR targeted therapy (apalutamide)
Prior use of apalutamide
Cannot have received: CD105 targeted antibody (carotuximab)
Prior exposure to carotuximab or any CD105 targeted antibody
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- Cedars-Sinai Medical Center · Los Angeles, California
- Huntsman Cancer Institute and Hospital · Salt Lake City, Utah
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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