This Phase 2, open-label, multicenter study is conducted in patients with castration-resistant prostate cancer. Patients in this study receive MRT-2359, an investigational oral medicine, in combination with apalutamide, an oral medicine used to treat prostate cancer. The main purpose of the study is to assess whether this treatment combination can lower prostate-specific antigen (PSA) The study will also evaluate the safety and tolerability of the treatment combination and assess additional measures of anti-tumor activity.
This Phase 2, open-label, multicenter study is designed to assess the efficacy, safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of MRT-2359 in combination with apalutamide in patients with castration-resistant prostate cancer. The primary aim of the study is to assess the PSA response rate of MRT-2359 in combination with apalutamide as determined by PCWG4 criteria. Secondary aims include further evaluation of safety and tolerability, additional measures of anti-tumor activity, and characterization of the PK profile of MRT-2359 in combination with apalutamide.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Orally administered tablets of MRT-2359
Orally administered apalutamide
START Los Angeles
Los Angeles, California, United States
RECRUITINGHoag Memorial Hospital Presbyterian
Newport Beach, California, United States
NOT_YET_RECRUITINGRocky Mountain Cancer Center
Colorado Springs, Colorado, United States
NOT_YET_RECRUITINGKansas University Cancer Center
Kansas City, Kansas, United States
NOT_YET_RECRUITINGUniversity of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
NOT_YET_RECRUITINGHenry Ford
Novi, Michigan, United States
NOT_YET_RECRUITINGXCancer Omaha
Omaha, Nebraska, United States
RECRUITINGSTART New Jersey
East Brunswick, New Jersey, United States
RECRUITINGLevine Cancer Institute
Charlotte, North Carolina, United States
NOT_YET_RECRUITINGLancaster Urology
Lancaster, Pennsylvania, United States
NOT_YET_RECRUITING...and 4 more locations
Assess the efficacy of MRT-2359 combined with apalutamide
Assess the efficacy of MRT-2359 combined with apalutamide using the PSA response rate as determined by PCWG4 criteria in participants with measurable and/or evaluable disease
Time frame: 14 months
Further evaluation of the safety and tolerability of MRT-2359 administered orally in combination with apalutamide
Further evaluate the safety and tolerability of MRT-2359 administered orally in combination with apalutamide over a 28-day cycle by the nature, incidence, and severity of all adverse events
Time frame: 20 months
To assess additional measures of the efficacy of MRT-2359 in combination with apalutamide
Objective response rate as determined by RECIST 1.1
Time frame: 20 months
To assess additional measures of the efficacy of MRT-2359 in combination with apalutamide
Duration of response (DoR) in participants with CR or PR per RECIST 1.1
Time frame: 20 months
To assess additional measures of the efficacy of MRT-2359 in combination with apalutamide
Duration of response (DoR) in participants with the best overall response of PSA50 per PCWG4
Time frame: 20 months
To assess additional measures of the efficacy of MRT-2359 in combination with apalutamide
Disease control rate (DCR) per RECIST 1.1
Time frame: 20 months
To assess additional measures of the efficacy of MRT-2359 in combination with apalutamide
Radiographic progression free survival (PFS)
Time frame: 20 months
To assess additional measures of the efficacy of MRT-2359 in combination with apalutamide
PSA progression free survival (PFS)
Time frame: 20 months
To assess additional measures of the efficacy of MRT-2359 in combination with apalutamide
Overall survival (OS)
Time frame: 20 months
To characterize the population pharmacokinetic profile of MRT-2359 in combination with apalutamide
Peak Plasma Concentration (Cmax)
Time frame: 20 months
To characterize the population pharmacokinetic profile of MRT-2359 in combination with apalutamide
Minimum Plasma Concentration (Cmin)
Time frame: 20 months
To characterize the population pharmacokinetic profile of MRT-2359 in combination with apalutamide
Area Under the Plasma Concentration-time Curve (AUC)
Time frame: 20 months
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