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

Study Identifier:
MRT-2359-002
CT.gov Identifier:
NCT07745361
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Will Be Recruiting

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
N/A
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase II
Sex
Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: MRT-2359 + Apalutamide
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Drug: Participants with castration-resistant prostate cancer will receive MRT-2359 in combination with apalutamide.
Drug: Drug: Apalutamide
Drug: Orally administered apalutamide
Drug: Drug: Oral MRT-2359
Drug: Orally administered tablets of MRT-2359
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Status
Recruiting
Condition(s) Treated at Site
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Status
Recruitment Complete
Condition(s) Treated at Site
Location
START Barcelona
Barcelona, Spain, 08023
Investigator
Status
Recruitment Complete
Condition(s) Treated at Site