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OncoMatch/Clinical Trials/NCT07745361

Study of Oral MRT-2359 With Apalutamide in Prostate Cancer

Is NCT07745361 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Oral MRT-2359 and Apalutamide for castration-resistant prostate cancer (crpc).

Phase 2RecruitingMonte Rosa Therapeutics, IncNCT07745361Data as of Sep 2026

Treatment: Oral MRT-2359 · ApalutamideThis 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.

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Extracted eligibility criteria

Treatments studied

Endocrine / hormonal

Apalutamide

Other

Oral MRT-2359

Cancer type

Prostate Cancer

Biomarker criteria

Required: AR mutation

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Male only

Prior therapy

Must have received: androgen receptor pathway inhibitor

Has received prior treatment with at least 1 line of ARPi

Cannot have received: taxane-based chemotherapy

Exception: no more than 1 prior regimen for castration-resistant prostate cancer

Have not had prior treatment with more than 1 prior taxane-based chemotherapy regimen for castration-resistant prostate cancer

Cannot have received: AR degrader

Have no prior treatment with an AR degrader, opevesostat, or similar therapy

Cannot have received: GSPT1 degrader

Exception: only if discontinued due to an AE

Have received prior therapy with a GSPT1 degrader that was discontinued due to an AE

Cannot have received: autologous hematopoietic cell transplant

Exception: unless fully recovered from effects of last transplant

Have received prior auto-HCT and have not fully recovered from effects of the last transplant

Cannot have received: allogeneic hematopoietic stem cell transplantation

Exception: within past 6 months and/or have symptoms of graft-versus-host disease

Have received allogeneic hematopoietic stem cell transplantation within past 6 months and/or have symptoms of graft-versus-host disease

Lab requirements

Blood counts

Kidney function

Liver function

Have adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • START Los Angeles · Los Angeles, California
  • Hoag Memorial Hospital Presbyterian · Newport Beach, California
  • Rocky Mountain Cancer Center · Colorado Springs, Colorado
  • Kansas University Cancer Center · Kansas City, Kansas
  • University of Maryland Greenebaum Cancer Center · Baltimore, Maryland

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07745361 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior taxane-based chemotherapy, AR degrader, GSPT1 degrader disqualifies patients from enrollment.

Does this trial require AR?

Yes, AR mutation is a required biomarker for enrollment.

Is this trial open to female patients?

No. This trial enrolls male patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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