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NCT Number: NCT05534646

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

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.

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Key information

Conditions

Castration-resistant Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

City of Hope, Duarte, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apalutamide

Drug

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

Carotuximab

Drug

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 outcomes

  1. 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.

    From the start of study treatment until documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3, or death due to any cause.

Secondary outcomes

  1. Incidence of Adverse events (grade 3 or higher) related to carotuximab and apalutamide

    Time frame: From start of study treatment through 4 weeks on treatment

    Grade 3 or above treatment related adverse events as assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  2. Overall radiographic response rate (ORR) of the combination of apalutamide + carotuximab

    Time frame: From the start of combination study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.

    Participants of the combination of apalutamide + carotuximab, with confirmed complete response (CR) or partial response (PR) per RECIST v.1.1 and Prostate Cancer Working Group 3

  3. Proportion of patients resistant to apalutamide benefit from the addition of carotuximab

    Time frame: From the start of combination therapy study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.

    Participants of the monotherapy group that crossover to combination therapy at progression, with confirmed complete response (CR) or partial response (PR) per RECIST v.1.1 and Prostate Cancer Working Group 3

  4. Overall radiographic response rate (ORR) in the overall population

    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.

    Determined by confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3

  5. To determine the radiographic progression free survival (rPFS) in the overall population

    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.

    From the start of study treatment until documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3, or death due to any cause.

  6. To determine the biochemical PFS (by PCWG3) in the overall population

    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.

    From the start of study treatment until documented progression, per Prostate Cancer Working Group 3, or death due to any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Recruitment Navigator

CONTACT

[email protected]

3104232133

Sponsors and collaborators

Lead sponsor

Edwin Posadas, MD

Other

Collaborators

  • Enviro Therapeutics, Inc.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2022
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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