Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
Start Date
12/27/2023
Completion Date
1/1/2027
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Apalutamide
Carotuximab
Conditions
Locations
City of Hope
Duarte, California 91010
United States
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Huntsman Cancer Institute and Hospital
Salt Lake City, Utah 84112
United States