Recruiting
Phase 2

MRT-2359 & Apalutamide

Sponsor:

Monte Rosa Therapeutics, Inc

Code:

NCT07745361

Conditions

Castration-Resistant Prostate Cancer (CRPC)

Castration-Resistant Prostate Cancer

Prostate Cancer

Prostate Cancer (Adenocarcinoma)

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oral MRT-2359

Apalutamide

Study Details

Brief summary:

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.

Conditions

Castration-Resistant Prostate Cancer (CRPC)

Castration-Resistant Prostate Cancer

Prostate Cancer

Prostate Cancer (Adenocarcinoma)

Study ID

NCT07745361

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MRT-2359 + Apalutamide

Participants with castration-resistant prostate cancer will receive MRT-2359 in combination with apalutamide.

Interventions

Oral MRT-2359

Orally administered tablets of MRT-2359

Apalutamide

Orally administered apalutamide

Primary outcome measure

  • Assess the efficacy of MRT-2359 combined with apalutamide [ Time Frame: 14 months ]

Central Contacts and Locations

Central contacts

Monte Rosa Therapeutics Sponsor

617-865-4792MRT-2359-002StudyTeam@monterosatx.com

Locations

START Los Angeles

Recruiting

Los Angeles, California, United States, 90025

XCancer Omaha

Recruiting

Omaha, Nebraska, United States, 68130

START New Jersey

Recruiting

East Brunswick, New Jersey, United States, 08816

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

More Information

Sponsor

Monte Rosa Therapeutics, Inc

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • MRT-2359
  • apalutamide
  • castration-resistant prostate cancer
  • CRPC
  • androgen receptor mutation
  • AR mutation
  • PSA response
  • androgen receptor inhibitor
  • molecular glue degrader
  • GSPT1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by Monte Rosa Therapeutics, Inc on 2026-08-24.