Recruiting NCT07745361

Study of Oral MRT-2359 With Apalutamide in Prostate Cancer

Phase II Interventional Castration-Resistant Prostate Cancer (CRPC) Castration-Resistant Prostate Cancer Prostate Cancer Prostate Cancer (Adenocarcinoma)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Oral MRT-2359, Apalutamide.
Who it may be relevant to: Registry conditions: Castration-Resistant Prostate Cancer (CRPC), Castration-Resistant Prostate Cancer, Prostate Cancer, Prostate Cancer (Adenocarcinoma). Basic parameters: from 18 years · Male.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

This Phase 2, open-label, multicenter study is designed to assess the efficacy, safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of MRT-2359 in combination with apalutamide in patients with castration-resistant prostate cancer.

The primary aim of the study is to assess the PSA response rate of MRT-2359 in combination with apalutamide as determined by PCWG4 criteria.

Secondary aims include further evaluation of safety and tolerability, additional measures of anti-tumor activity, and characterization of the PK profile of MRT-2359 in combination with apalutamide.

Interventions

Drug Oral MRT-2359
Orally administered tablets of MRT-2359
Drug Apalutamide
Orally administered apalutamide

Primary outcome measures

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

Secondary outcome measures (11)

Further evaluation of the safety and tolerability of MRT-2359 administered orally in combination with apalutamide [Time frame: 20 months]
To assess additional measures of the efficacy of MRT-2359 in combination with apalutamide [Time frame: 20 months]
To assess additional measures of the efficacy of MRT-2359 in combination with apalutamide [Time frame: 20 months]
To assess additional measures of the efficacy of MRT-2359 in combination with apalutamide [Time frame: 20 months]
To assess additional measures of the efficacy of MRT-2359 in combination with apalutamide [Time frame: 20 months]
To assess additional measures of the efficacy of MRT-2359 in combination with apalutamide [Time frame: 20 months]
To assess additional measures of the efficacy of MRT-2359 in combination with apalutamide [Time frame: 20 months]
To assess additional measures of the efficacy of MRT-2359 in combination with apalutamide [Time frame: 20 months]
To characterize the population pharmacokinetic profile of MRT-2359 in combination with apalutamide [Time frame: 20 months]
To characterize the population pharmacokinetic profile of MRT-2359 in combination with apalutamide [Time frame: 20 months]
To characterize the population pharmacokinetic profile of MRT-2359 in combination with apalutamide [Time frame: 20 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 14 centers

START Los Angeles — Los Angeles
Hoag Memorial Hospital Presbyterian — Newport Beach
Rocky Mountain Cancer Center — Colorado Springs
Kansas University Cancer Center — Kansas City
University of Maryland Greenebaum Cancer Center — Baltimore
Henry Ford — Novi
XCancer Omaha — Omaha
START New Jersey — East Brunswick
… and 6 more centers

Identifiers

NCT: NCT07745361 · MRT-2359-002

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗