MRT-2359 plus apalutamide in advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, open-label, multicenter study in adults with castration-resistant prostate cancer. Participants will receive MRT-2359 together with apalutamide to see if the combination lowers PSA and to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity. The primary goal is to determine the PSA response rate per standard criteria, while secondary goals cover safety, additional anti-tumor measures, and PK profiling. The study design focuses on patients who have limited prior taxane exposure and specific AR mutation profiles.

Why it matters

Who can join: the full rules

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 it's running

• START Los Angeles
  Los Angeles, California, United States Recruiting
• XCancer Omaha
  Omaha, Nebraska, United States Recruiting
• START New Jersey
  East Brunswick, New Jersey, United States Recruiting
• Lancaster Urology
  Lancaster, Pennsylvania, United States Recruiting
• START Mountain Region
  West Valley City, Utah, United States Recruiting
• Virginia Cancer Specialists
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: Monte Rosa Therapeutics Sponsor
• Email: MRT-2359-002StudyTeam@monterosatx.com
• Phone: 617-865-4792

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.