Study of Oral MRT-2359 With Apalutamide in Prostate Cancer
MODeFIRe-1 (Molecular Degrader for Inhibitor Resistance): A Phase 2, Open-Label, Multicenter Study of Oral MRT-2359 in Combination With Apalutamide in Patients With Castration-Resistant Prostate Cancer
About This Trial
- This clinical trial is testing whether combining a new experimental pill, MRT-2359, with an approved cancer drug called apalutamide can safely slow tumor growth and lower prostate cancer blood markers (PSA).
- It is designed for adults with advanced prostate cancer that has continued to grow despite previous hormone treatments and has specific genetic changes.
- Both study medications are pills taken by mouth.
- Before joining, patients should know that they will need to provide a small tumor tissue sample (biopsy) and undergo health checks to ensure their heart, lungs, and other organs are healthy enough for the study.
More Information
- 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.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This clinical trial is testing whether combining a new experimental pill, MRT-2359, with an approved cancer drug called apalutamide can safely slow tumor growth and lower prostate cancer blood markers (PSA).
Study Details
- Start Date: August 18, 2026
- Lead Sponsor: Monte Rosa Therapeutics, Inc
Full Eligibility Criteria
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 nM)
- Has received prior treatment with poly(ADP-ribose) polymerase (PARP) inhibitor, if appropriate, or deemed ineligible to receive treatment by the Investigator, or has refused PARP inhibitor treatment
- Has received prior treatment with at least 1 line of ARPi
- Have disease measurable per Prostate Cancer Working Group 4 (PCWG4) criteria, with or without measurable disease by RECIST 1.1
- Be able to provide a tumor biopsy for biomarker analysis during the Screening period
- Have adequate organ function
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
- 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
- Current use of chronic systemic steroid therapy in excess of replacement doses
- Have clinically active central nervous system involvement and/or carcinomatous meningitis
- Have a confirmed history of (noninfectious) pneumonitis that required steroids
- Clinically significant cardiac disease
Treatments
- Drug: Oral MRT-2359
- Drug: Apalutamide