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Trial Title:
Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
NCT ID:
NCT05534646
Condition:
Castration-resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate cancer
Castration-resistant
CRPC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Apalutamide
Description:
Standard of care Apalutamide 240 mg administered orally and daily on Days 1-28 of every
28 day cycle
Arm group label:
Apalutamide monotherapy
Arm group label:
Combination therapy (Apalutamide + Carotuximab)
Intervention type:
Drug
Intervention name:
Carotuximab
Description:
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.
Arm group label:
Combination therapy (Apalutamide + Carotuximab)
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.
Criteria for 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Tanya Dorff, MD
Phone:
626-256-4673
Email:
tdorff@coh.org
Facility:
Name:
Cedars-Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trial Recruitment Navigator
Phone:
310-423-2133
Email:
cancer.trial.info@cshs.org
Investigator:
Last name:
Robert Figlin, MD FACP
Email:
Sub-Investigator
Investigator:
Last name:
Jun Gong, MD
Email:
Sub-Investigator
Investigator:
Last name:
Kevin Scher, MD MBA
Email:
Sub-Investigator
Investigator:
Last name:
David Hoffman, MD
Email:
Sub-Investigator
Investigator:
Last name:
Leland Green, MD
Email:
Sub-Investigator
Investigator:
Last name:
Kristopher Wentzel, MD
Email:
Sub-Investigator
Facility:
Name:
Huntsman Cancer Institute and Hospital
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Umang Swami, MD
Phone:
801-587-4381
Email:
Umang.Swami@hci.utah.edu
Start date:
December 27, 2023
Completion date:
January 2027
Lead sponsor:
Agency:
Edwin Posadas, MD
Agency class:
Other
Collaborator:
Agency:
Enviro Therapeutics, Inc.
Agency class:
Other
Source:
Cedars-Sinai Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05534646
