Monte Rosa Therapeutics, Inc
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 apalu…
Inclusion Criteria: * Age \> 18 years * A predicted life expectancy of ≥ 3 months and an ECOG performance status ≤ 1 * Have histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate without small cell histology and with androgen receptor (AR) mutations * Have not had prior treatment with more than 1 prior taxane-based chemotherapy regimen for castration-resistant prostate cancer * Have no prior treatment with an AR degrader, opevesostat, or similar therapy * Has ongoing (chemical or surgical) androgen deprivation with serum testosterone \< 50 ng/dL (\< 1.7…
Orally administered tablets of MRT-2359
Orally administered apalutamide