NCT05534646

Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer

Phase II Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Edwin Posadas, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Apalutamide	Standard of care Apalutamide 240 mg administered orally and daily on Days 1-28 of every 28 day cycle
DRUG	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.

Timeline

• Start date: 2023-12-27
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2022-09-09
• Last updated: 2026-02-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study