Study of AR Suppression With Carotuximab in Metastatic, Castration-Resistant Prostate Canc

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 obje

Trial Details

NCT ID
NCT05534646
Phase
PHASE2
Sponsor
Edwin Posadas, MD
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Apalutamide
  • Carotuximab
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Los Angeles, California, United States|34.05223,-118.24368
  • Salt Lake City, Utah, United States|40.76078,-111.89105

Key Eligibility Criteria

  • History of castration-resistant prostate cancer with rising PSA on a contemporary ARSI (e.g. abiraterone or, enzalutamide, darolutamide). Bicalutam…
  • PSA rise will be defined as an increase in PSA of 0.2 ng/mL or higher on at least 2 separate occasions greater than 1 week apart while on an ARSI
  • Patient must be surgically castrated or have serum testosterone concentrations much be consistent with castrate levels of testosterone (under 50 ng…
  • 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…

For full eligibility, visit ClinicalTrials.gov.

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