Actively Recruiting
Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
Led by Edwin Posadas, MD · Updated on 2026-02-02
100
Participants Needed
3
Research Sites
157 weeks
Total Duration
On this page
Sponsors
E
Edwin Posadas, MD
Lead Sponsor
E
Enviro Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of castration-resistant prostate cancer with rising PSA on a contemporary androgen receptor signaling inhibitor (ARSI) therapy (abiraterone, enzalutamide, darolutamide). Bicalutamide, nilutamide, and flutamide are not considered contemporary ARSIs
- Patient must have had 1 and can have up to 2 prior AR targeted therapies except apalutamide
- Patients must decline or be ineligible for taxane therapy as determined by their treating physician
- All patients must agree to use an adequate method of contraception during treatment and for 3 months after the last dose of apalutamide and/or carotuximab
You will not qualify if you...
- Non-PSA producing prostate cancers such as small cell prostate cancers or those with 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 medical conditions with a high risk of bleeding
- Known diagnosis of Osler-Weber-Rendu syndrome
AI-Screening
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Trial Site Locations
Total: 3 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
Huntsman Cancer Institute and Hospital
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
C
Clinical Trial Recruitment Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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