RecruitingPhase 2NCT05534646

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

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

Sponsor

Edwin Posadas, MD

Enrollment

100 participants

Start Date

Dec 27, 2023

Study Type

INTERVENTIONAL

Conditions

Castration-resistant Prostate Cancer

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — apalutamide and carotuximab — for men with advanced prostate cancer that has stopped responding to hormone therapy. Researchers want to see whether adding carotuximab, which targets a protein that helps tumors grow blood vessels, can improve outcomes. **You may be eligible if:** - You have prostate cancer that has spread and is no longer controlled by hormone-lowering treatment - Your PSA (a prostate cancer marker in the blood) has been rising while on a modern hormone-blocking drug (such as abiraterone, enzalutamide, or darolutamide) - You have had 1 or 2 prior hormone-blocking treatments, but NOT apalutamide - You are not a candidate for (or decline) chemotherapy with taxanes - You are willing to use contraception during treatment and for 3 months after **You may NOT be eligible if:** - Your prostate cancer does not produce PSA (e.g., small cell type) - You have previously taken apalutamide - You have another active cancer requiring treatment - You have previously received carotuximab or similar drugs - You have active bleeding problems or a condition called Osler-Weber-Rendu syndrome Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGApalutamide

Standard of care Apalutamide 240 mg administered orally and daily on Days 1-28 of every 28 day cycle

DRUGCarotuximab

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.