A Phase 2 interventional study of Oral MRT-2359 and Apalutamide in Castration-Resistant Prostate Cancer (CRPC), Castration-Resistant Prostate Cancer and Prostate Cancer, sponsored by Monte Rosa Therapeutics, Inc. Recruiting at 14 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Monte Rosa Therapeutics, Inc · Phase 2, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 25 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Monte Rosa Therapeutics, Inc is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Have received prior chemotherapy, definitive radiation, or biological cancer therapy within 21 days before the first dose of study treatment or have any AEs that have failed to recover to baseline
Participants with castration-resistant prostate cancer will receive MRT-2359 in combination with apalutamide.
Drug: Oral MRT-2359 · Drug: Apalutamide
Orally administered tablets of MRT-2359
Orally administered apalutamide
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
Plan to share: No
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Monte Rosa Therapeutics, Inc