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RECRUITING
NCT05534646
PHASE2

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

Sponsor: Edwin Posadas, MD

View on ClinicalTrials.gov

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

Interventions

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.

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