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

Edwin Posadas, MD

Status and phase: Enrolling; Phase 2

Conditions: Castration-resistant Prostate Cancer

Treatments: Drug: Apalutamide; Drug: Carotuximab

Study type: Interventional

Funder types: Other

Identifiers

NCT05534646

IIT2021-06-Posadas-APA105

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Apalutamide monotherapy

Active Comparator group

Description:

After progression, subjects will crossover to combination therapy

Treatment:

Drug: Apalutamide

Combination therapy (Apalutamide + Carotuximab)

Experimental group

Treatment:

Drug: Carotuximab

Drug: Apalutamide