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

Inclusion Criteria:

• History of castration-resistant prostate cancer with rising PSA (prostate-specificantigen) on a contemporary ARSI (Androgen receptor (AR) signaling inhibitor:abiraterone, enzalutamide, darolutamide). Bicalutamide, nilutamide, and flutamidewill not be considered as contemporary ARSIs

• Patient must have had 1 and can have up to 2 prior AR targeted therapy with theexception of apalutamide.

• Patients must decline or be ineligible for taxane therapy in the opinion of thetreating physician.

• All patients must agree to use an adequate method of contraception, in the opinionof the treating investigator, while on protocol treatment and for 3 months after thelast dose of protocol treatment (apalutamide and/or carotuximab)

Exclusion Criteria:

• Non-PSA producing prostate cancers such as small cell prostate cancers or thoseprostate 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