MRT-2359 plus apalutamide for castration-resistant prostate cancer
Tests MRT-2359 with apalutamide in adults with castration-resistant prostate cancer.
Plain-language title generated from the registry record
Registry title: Study of Oral MRT-2359 With Apalutamide in Prostate Cancer
Key facts
- Where
- Baltimore, Charlotte, Colorado Springs, East Brunswick, Fairfax, Kansas City, Lancaster, Los Angeles, Nashville, Newport Beach, Novi, Omaha, Seattle, and West Valley City, United StatesSee the 14 sites
- Phase
- Phase 2
Where in United States
- University of Maryland/Greenebaum Cancer CenterBaltimore, United StatesNot yet recruiting
- Levine Cancer InstituteCharlotte, United StatesNot yet recruiting
- Rocky Mountain Cancer CenterColorado Springs, United StatesNot yet recruiting
- START - New JerseyEast Brunswick, United StatesTaking people
- Virginia Cancer SpecialistsFairfax, United StatesTaking people
- Kansas University Cancer CenterKansas City, United StatesNot yet recruiting
- Lancaster UrologyLancaster, United StatesTaking people
- START - Los AngelesLos Angeles, United StatesTaking people
- Sarah Cannon Research InstituteNashville, United StatesNot yet recruiting
- Hoag Memorial Hospital PresbyterianNewport Beach, United StatesNot yet recruiting
- Henry FordNovi, United StatesNot yet recruiting
- XCancer OmahaOmaha, United StatesTaking people
- University of Washington Medical CenterSeattle, United StatesTaking people
- START Mountain RegionWest Valley City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Monte Rosa Therapeutics, Inc
- Trial code
- NCT07745361
- Record updated
- 5 November 2026
- Original description
This Phase 2, open-label, multicenter study is conducted in patients with castration-resistant prostate cancer.Read full original descriptionShow less
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
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.
Inclusion: 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: • 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.