RecruitingRecruiting
Study of Oral MRT-2359 With Apalutamide in Prostate Cancer
NCT07745361 · Monte Rosa Therapeutics, Inc
In plain English
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Official title
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 study
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.
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
Study design
Enrollment target: 25 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-08
Estimated completion: 2028-04
Last updated: 2026-08-24
Interventions
Drug: Oral MRT-2359Drug: Apalutamide
Primary outcomes
- • Assess the efficacy of MRT-2359 combined with apalutamide (14 months)
Sponsor
Monte Rosa Therapeutics, Inc · industry
Contacts & investigators
ContactMonte Rosa Therapeutics Sponsor · contact · MRT-2359-002StudyTeam@monterosatx.com · 617-865-4792
All locations (14)
START Los AngelesRecruiting
Los Angeles, California, United States
Hoag Memorial Hospital PresbyterianNot Yet Recruiting
Newport Beach, California, United States
Rocky Mountain Cancer CenterNot Yet Recruiting
Colorado Springs, Colorado, United States
Kansas University Cancer CenterNot Yet Recruiting
Kansas City, Kansas, United States
University of Maryland Greenebaum Cancer CenterNot Yet Recruiting
Baltimore, Maryland, United States
Henry FordNot Yet Recruiting
Novi, Michigan, United States
XCancer OmahaRecruiting
Omaha, Nebraska, United States
START New JerseyRecruiting
East Brunswick, New Jersey, United States
Levine Cancer InstituteNot Yet Recruiting
Charlotte, North Carolina, United States
Lancaster UrologyNot Yet Recruiting
Lancaster, Pennsylvania, United States
Sarah Cannon Research InstituteNot Yet Recruiting
Nashville, Tennessee, United States
START Mountain RegionRecruiting
West Valley City, Utah, United States
Virginia Cancer SpecialistsNot Yet Recruiting
Fairfax, Virginia, United States
University of Washington Medical CenterNot Yet Recruiting
Seattle, Washington, United States