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.
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 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
Have received prior therapy with a GSPT1 degrader that was discontinued due to an AE
Have received prior auto-HCT and have not fully recovered from effects of the last transplant
Have received allogeneic hematopoietic stem cell transplantation within past 6 months and/or have symptoms of graft-versus-host disease
Single group
Oral MRT-2359
DrugOrally administered tablets of MRT-2359
Apalutamide
DrugOrally 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
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
To assess additional measures of the efficacy of MRT-2359 in combination with apalutamide
Objective response rate as determined by RECIST 1.1
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
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
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