NCT07745361 · Monte Rosa Therapeutics, Inc
Study of Oral MRT-2359 With Apalutamide in Prostate Cancer
(MODeFIRe-1)
What this study is about
This Phase 2, where both patients and doctors know the treatment given, conducted at multiple hospitals study is conducted in patients with castration-resistant prostate cancer. Patients in this study receive MRT-2359, an experimental taken by mouth medicine, in combination with apalutamide, an taken by mouth medicine used to treat prostate cancer.
View original scientific description
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.
Interventions
DRUG
Oral MRT-2359
Orally administered tablets of MRT-2359
DRUG
Apalutamide
Orally administered apalutamide
Primary outcome measures
Assess the efficacy of MRT-2359 combined with apalutamide
Time frame: 14 months
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
- Newport Beach, California
- Colorado Springs, Colorado
- Kansas City, Kansas
- Baltimore, Maryland
- Novi, Michigan
- Omaha, Nebraska
- East Brunswick, New Jersey
- Charlotte, North Carolina
- Lancaster, Pennsylvania
- Nashville, Tennessee
- West Valley City, Utah
And 2 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 4, 2026 · Source of record for eligibility and locations