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Study of Oral MRT-2359 in Selected Cancer Patients

NCT05546268 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2026-03-03

No results posted yet for this study

Summary

This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer of any primary site, diffuse large B-cell lymphoma (DLBCL), and tumors with L-MYC or N-MYC amplification. Patients receive escalating doses of a GSPT1 molecular glue degrader MRT-2359 to determine safety, tolerability, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of MRT-2359. Once the MTD and/or RP2D is identified, additional patients enroll to Phase 2 study, which includes molecular biomarkers stratification or selection, namely expression or amplification of L-MYC and N-MYC genes, hormone receptor positive (HR)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer and prostate cancer.

Conditions

  • NSCLC
  • SCLC
  • High Grade Neuroendocrine Cancer
  • DLBCL
  • L-MYC and N-MYC Amplified Solid Tumors
  • NSCLC With High or Low L-MYC or N-MYC Expression
  • HR-positive, HER2-negative Breast Cancer
  • Prostate Cancer

Interventions

DRUG

Oral MRT-2359

Orally administered tablets of MRT-2359 in conjunction with orally administered enzalutamide.

DRUG

Oral MRT-2359

Orally administered tablets of MRT-2359.

DRUG

Oral MRT-2359

Orally administered tablets of MRT-2359.

DRUG

Oral MRT-2359

Orally administered tablets of MRT-2359.

DRUG

Oral MRT-2359

Orally administered tablets of MRT-2359.

DRUG

Oral MRT-2359

Orally administered tablets of MRT-2359 in conjunction with intramuscular administration of fulvestrant.

Sponsors & Collaborators

  • Monte Rosa Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-12
Primary Completion
2026-05-31
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05546268 on ClinicalTrials.gov