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

Part of paid clinical trials in Duarte, California.

Sponsor
Edwin Posadas, MD
Study ID
NCT05534646
Phase
PHASE2
Status
Recruiting
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Conditions

  • Castration-resistant Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 27, 2023
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Apalutamide monotherapy
    After progression, subjects will crossover to combination therapy
  • Experimental: Combination therapy (Apalutamide + Carotuximab)

Primary Outcome Measure

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. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Tanya Dorff, MD
[email protected]
626-256-4673
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
[email protected]
310-423-2133
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 (SUB_INVESTIGATOR)
Huntsman Cancer Institute and HospitalSalt Lake CityUtah84112
Umang Swami, MD
[email protected]
801-587-4381

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By research site
City of Hope· Duarte, CACedars-Sinai Medical Center· Los Angeles, CAHuntsman Cancer Institute and Hospital· Salt Lake City, UT

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