Recruiting
Phase 2

Apalutamide & Carotuximab

Sponsor:

Edwin Posadas, MD

Code:

NCT05534646

Conditions

Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Apalutamide

Carotuximab

Study Details

Brief 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.

Conditions

Castration-resistant Prostate Cancer

Study ID

NCT05534646

Start date

Dec 27, 2023

Status verified date

Jan, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Apalutamide monotherapy

After progression, subjects will crossover to combination therapy

experimental: Combination therapy (Apalutamide + Carotuximab)

Interventions

Apalutamide

Standard of care Apalutamide 240 mg administered orally and daily on Days 1-28 of every 28 day cycle

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.

Primary outcome measure

  • Progression free survival (rPFS) between patients receiving apalutamide and apalutamide + carotuximab [ Time Frame: From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment. ]

Central Contacts and Locations

Central contacts

Clinical Trial Recruitment Navigator

3104232133cancer.trial.info@cshs.org

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Tanya Dorff, MD

626-256-4673tdorff@coh.org

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Clinical Trial Recruitment Navigator

310-423-2133cancer.trial.info@cshs.org

Huntsman Cancer Institute and Hospital

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Umang Swami, MD

801-587-4381Umang.Swami@hci.utah.edu

More Information

Sponsor

Edwin Posadas, MD

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Keywords

  • Prostate cancer
  • Castration-resistant
  • CRPC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Edwin Posadas, MD on 2026-02-02.