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RecruitingPhase 2

Study of Oral MRT-2359 With Apalutamide in Prostate Cancer

MODeFIRe-1 (Molecular Degrader for Inhibitor Resistance): A Phase 2, Open-Label, Multicenter Study of Oral MRT-2359 in Combination With Apalutamide in Patients With Castration-Resistant Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests MRT-2359, an experimental pill, with apalutamide, a prostate cancer pill. It is for adults whose prostate cancer keeps growing despite treatment to lower testosterone. Researchers will check whether the drugs lower PSA, a blood marker for prostate cancer, and study their safety and effects on tumors.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18, expected to live at least 3 months, and able to do most daily activities.
  • Have prostate adenocarcinoma confirmed by tissue or cell tests, with no small cell cancer. The cancer must resist testosterone-lowering treatment and have androgen receptor (AR) gene changes.
  • Have had no more than 1 course of taxane-type chemotherapy for this resistant cancer, and no prior AR degrader, opevesostat, or similar treatment.
  • Have ongoing testosterone lowering through medicine or surgery, with a testosterone level below 50 ng/dL.
  • Have had at least 1 ARPi treatment, which blocks male hormone signals. Also, have had a PARP inhibitor if appropriate, been judged unable to receive it, or refused it.
  • Have cancer that can be measured under the study’s prostate cancer rules.
  • Be able to give a tumor tissue sample during screening for lab testing.
  • Have organs that work well enough for the study.

Who can't join

  • Had chemotherapy, radiation meant to treat the cancer fully, or biological cancer treatment within 21 days before the first study dose, or still have treatment side effects above your usual level.
  • Previously stopped a GSPT1 degrader, a type of drug, because of a side effect.
  • Had a stem cell transplant using your own cells and have not fully recovered.
  • Had a donor stem cell transplant in the past 6 months, or have symptoms of graft-versus-host disease, when donor cells attack your body.
  • Regularly take steroids that affect the whole body at doses above those needed to replace natural hormones.
  • Have active cancer affecting the brain or spinal cord, or cancer in the tissue covering them.
  • Have a confirmed history of lung inflammation not caused by infection that needed steroid treatment.
  • Have significant heart disease.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (14)

CA

CO

KS

MD

MI

NC

NE

NJ

PA

TN

UT

VA

WA