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

NCT ID: NCT05534646

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-27
• Study Completion Date: 2027-01-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apalutamide monotherapy

After progression, subjects will crossover to combination therapy

Group Type: ACTIVE_COMPARATOR

Apalutamide

Intervention Type: DRUG

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

Combination therapy (Apalutamide + Carotuximab)

Group Type: EXPERIMENTAL

Apalutamide

Intervention Type: DRUG

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

Carotuximab

Intervention Type: 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.

Interventions

Apalutamide

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Enviro Therapeutics, Inc.

UNKNOWN

Sponsor Role: collaborator

Edwin Posadas, MD

OTHER

Sponsor Role: lead

Responsible Party

Edwin Posadas, MD

Co-Director, Experimental Therapeutics Program

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Edwin Posadas, MD FACP

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

City of Hope

Duarte, California, United States

Site Status: RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status: RECRUITING

Huntsman Cancer Institute and Hospital

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trial Recruitment Navigator

Role: CONTACT

cancer.trial.info@cshs.org

3104232133

Facility Contacts

Tanya Dorff, MD

Role: primary

tdorff@coh.org

626-256-4673

Clinical Trial Recruitment Navigator

Role: primary

cancer.trial.info@cshs.org

310-423-2133

Umang Swami, MD

Role: primary

Umang.Swami@hci.utah.edu

801-587-4381

Other Identifiers

IIT2021-06-Posadas-APA105

Identifier Type: -

Identifier Source: org_study_id