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RECRUITING Phase 2 ClinicalTrials.gov

Study of Oral MRT-2359 With Apalutamide in Prostate Cancer

Sponsor: Monte Rosa Therapeutics, Inc • ClinicalTrials.gov ID: NCT07745361

Registry updated: 2026-10-08
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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

  • Oral MRT-2359 (Drug)
    Orally administered tablets of MRT-2359
  • Apalutamide (Drug)
    Orally administered 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

Conditions

Castration-Resistant Prostate Cancer (CRPC) Castration-Resistant Prostate Cancer Prostate Cancer Prostate Cancer (Adenocarcinoma)

Locations

  • START Los Angeles — Los Angeles, California, United States
  • Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
  • Rocky Mountain Cancer Center — Colorado Springs, Colorado, United States
  • Kansas University Cancer Center — Kansas City, Kansas, United States
  • University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
  • Henry Ford — Novi, Michigan, United States
  • XCancer Omaha — Omaha, Nebraska, United States
  • START New Jersey — East Brunswick, New Jersey, United States
  • Levine Cancer Institute — Charlotte, North Carolina, United States
  • Lancaster Urology — Lancaster, Pennsylvania, United States
  • Sarah Cannon Research Institute — Nashville, Tennessee, United States
  • START Mountain Region — West Valley City, Utah, United States
  • Virginia Cancer Specialists — Fairfax, Virginia, United States
  • University of Washington Medical Center — Seattle, Washington, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record