We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05534646
Recruitment Status : Not yet recruiting
First Posted : September 9, 2022
Last Update Posted : September 9, 2022
Sponsor:
Collaborator:
Enviro Therapeutics, Inc.
Information provided by (Responsible Party):
Edwin Posadas, MD, Cedars-Sinai Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Castration-resistant Prostate Cancer Drug: Apalutamide Drug: Carotuximab Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Apalutamide

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Apalutamide monotherapy
After progression, subjects will crossover to combination therapy
 Drug: Apalutamide
Standard of care Apalutamide 240 mg administered orally and daily on Days 1-28 of every 28 day cycle
Experimental: Combination therapy (Apalutamide + Carotuximab) Drug: Apalutamide
Standard of care Apalutamide 240 mg administered orally and daily on Days 1-28 of every 28 day cycle

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Radiographic 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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05534646


Contacts
Layout table for location contacts
Contact: Clinical Trial Recruitment Navigator 3104232133 cancer.trial.info@cshs.org

Locations
Layout table for location information
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Contact: Clinical Trial Recruitment Navigator    310-423-2133    cancer.trial.info@cshs.org   
Sub-Investigator: Robert Figlin, MD FACP         
Sub-Investigator: Jun Gong, MD         
Sub-Investigator: Kevin Scher, MD MBA         
Sub-Investigator: David Hoffman, MD         
Sub-Investigator: Leland Green, MD         
Sub-Investigator: Kristopher Wentzel, MD         
Sponsors and Collaborators
Edwin Posadas, MD
Enviro Therapeutics, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Edwin Posadas, MD FACP Cedars-Sinai Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Edwin Posadas, MD, Co-Director, Experimental Therapeutics Program, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT05534646    
Other Study ID Numbers: IIT2021-06-Posadas-APA105
First Posted: September 9, 2022    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Edwin Posadas, MD, Cedars-Sinai Medical Center:
Prostate cancer
Castration-resistant
CRPC
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases