OncoMatch/Clinical Trials/NCT05534646
Study of AR Suppression With Carotuximab in Metastatic, Castration-Resistant Prostate Canc
Official title: Phase II Study of AR Suppression With Carotuximab in Metastatic, Castration-Resistant Prostate Canc
Is NCT05534646 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including AR Blockade and Carotuximab for castration-resistant prostate cancer.
Treatment: AR Blockade · Carotuximab — This is an open-label, multi-site study of AR Blockade 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 AR Blockade and AR Blockade + 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 AR blockade 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
Treatments studied
Other
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: androgen receptor targeted agent (abiraterone, enzalutamide, darolutamide) — castration-resistant prostate cancer
Patient must have had 1 and can have up to 2 prior AR targeted agents (if patients have had previous enzalutamide, they will be considered only for arm C). therapy with the exception of apalutamide.
Cannot have received: chemotherapy for castration-resistant prostate cancer
Exception: docetaxel administered for castration-sensitive disease
Patients may not have had previous chemotherapy with the exception of docetaxel administered for castration-sensitive disease.
Cannot have received: carotuximab or any CD105 targeted antibody
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 →Frequently asked questions
Is NCT05534646 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy for castration-resistant prostate cancer, carotuximab or any CD105 targeted antibody disqualifies patients from enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages