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ACTIVE NOT RECRUITING Phase 1

Study of Oral MRT-2359 in Selected Cancer Patients

NCT05546268 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Oral MRT-2359

Study Locations (17)

Texas

  • Mary Crowley Cancer Research — Dallas
  • MD Anderson Cancer Center — Houston
  • South Texas Accelerated Research Therapeutics (START) — San Antonio

Michigan

  • Henry Ford Cancer Institute — Detroit
  • South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids

New York

  • Memorial Sloan Kettering Cancer Center — New York
  • Columbia University Irving Medical Centre — New York

Arizona

  • Honor Health Research Institute — Scottsdale

California

  • University of California San Diego — San Diego

Connecticut

  • Yale University — New Haven

Kansas

  • University of Kansas Cancer Center — Lawrence

Massachusetts

  • Dana Farber Cancer Institute — Boston

Trial Details

FieldValue
Enrollment Target 174 participants
Start Date 2022-10-12
Est. Completion 2027-11
Phase Phase 1

Sponsor

Monte Rosa Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05546268

The ClinicalTrials.gov registry entry for NCT05546268 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Monte Rosa Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 8 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention — of which Oral MRT-2359 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05546268 reports 17 study locations spanning 13 distinct geographic areas — top geographies include Texas, Michigan, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05546268 about?

NCT05546268 is a clinical study titled "Study of Oral MRT-2359 in Selected Cancer Patients". 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 w...

What is the current status of trial NCT05546268?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 174 participants. The study started on 2022-10-12. Estimated completion is 2027-11.

What conditions does trial NCT05546268 study?

This clinical trial studies the following conditions: Prostate Cancer, NSCLC, DLBCL, SCLC, High Grade Neuroendocrine Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05546268?

The interventions under investigation include: Oral MRT-2359 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05546268?

This trial is sponsored by Monte Rosa Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05546268 being conducted?

This trial has 17 study locations across Arizona, California, Connecticut, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial