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

NCT05534646 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IIT2021-06-Posadas-APA105
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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

Keywords

Prostate cancer; Castration-resistant; CRPC

Outcome Measures

Primary Outcomes (1)

• Progression free survival (rPFS) between patients receiving apalutamide and apalutamide + carotuximab

  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.

  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.

Secondary Outcomes (6)

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

  From start of study treatment through 4 weeks on treatment

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

  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.

• Proportion of patients resistant to apalutamide benefit from the addition of carotuximab

  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.

• Overall radiographic response rate (ORR) in the overall population

  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.

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

  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.

Study Arms (2)

Apalutamide monotherapy

ACTIVE COMPARATOR

After progression, subjects will crossover to combination therapy

Drug: Apalutamide

Combination therapy (Apalutamide + Carotuximab)

EXPERIMENTAL

Drug: Apalutamide; Drug: Carotuximab

Interventions

Apalutamide DRUG

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

Apalutamide monotherapy; Combination therapy (Apalutamide + Carotuximab)

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.

Combination therapy (Apalutamide + Carotuximab)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Edwin Posadas, MD: lead
• Enviro Therapeutics, Inc.: collaborator

Study Sites (3)

City of Hope

Duarte, California, 91010, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Huntsman Cancer Institute and Hospital

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide; carotuximab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Edwin Posadas, MD FACP

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Recruitment Navigator

CONTACT

3104232133; cancer.trial.info@cshs.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Director, Experimental Therapeutics Program

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: December 27, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)