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Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
Sponsor: Edwin Posadas, MD
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.
Official title: Phase II Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-12-27
Completion Date
2027-01
Last Updated
2026-02-02
Healthy Volunteers
No
Conditions
Interventions
Apalutamide
Standard of care Apalutamide 240 mg administered orally and daily on Days 1-28 of every 28 day cycle
Carotuximab
Carotuximab administered intravenously at the following doses: Cycle 1 Day 1: 3 mg/kg Cycle 1 Day 4: 7 mg/kg Cycle 1 Day 8: 10 mg/kg Cycle 1 Day 15: 10 mg/kg Cycle 1 Day 22: 10 mg/kg Cycle 2 Day 1: 15 mg/kg Cycle 2 Day 15: 15 mg/kg Cycle 3+ Day 1: 15 mg/kg After completion of cycle 2, dosing of carotuximab will continue at a q4 week schedule using the 15 mg/kg dose.
Locations (3)
City of Hope
Duarte, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Huntsman Cancer Institute and Hospital
Salt Lake City, Utah, United States