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

Recruiting now · Phase 2

Conditions studied: Castration-resistant Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05534646

Run by

Edwin Posadas, MD

People needed

100

Starts

2023-12-27

Expected to finish

2027-01-01

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• History of castration-resistant prostate cancer with rising PSA (prostate-specific antigen) on a contemporary ARSI (Androgen receptor (AR) signaling inhibitor: abiraterone, enzalutamide, darolutamide). Bicalutamide, nilutamide, and flutamide will not be considered as contemporary ARSIs
• Patient must have had 1 and can have up to 2 prior AR targeted therapy with the exception of apalutamide.
• Patients must decline or be ineligible for taxane therapy in the opinion of the treating physician.
• All patients must agree to use an adequate method of contraception, in the opinion of the treating investigator, while on protocol treatment and for 3 months after the last dose of protocol treatment (apalutamide and/or carotuximab)

You may not qualify if…

• Non-PSA producing prostate cancers such as small cell prostate cancers or those prostate cancers which exhibit radiographic progression without PSA rise
• Prior use of apalutamide
• Other prior malignancy requiring active anticancer therapy
• Prior exposure to carotuximab or any CD105 targeted antibody
• Active bleeding or pathologic medical conditions that carries a high bleeding risk
• A known diagnosis of Osler-Weber-Rendu syndrome

Where it is running

• City of Hope — Duarte, California, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Huntsman Cancer Institute and Hospital — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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