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NCT05546268 · ClinicalTrials.gov registry record · Phase 1

Study of Oral MRT-2359 in Selected Cancer Patients

A Phase 1 study of Prostate Cancer and NSCLC, sponsored by Monte Rosa Therapeutics.

Active
Registry status
Phase 1
Development phase
174
Enrollment target
17
Study locations

NCT05546268 is a Phase 1 study of Prostate Cancer and NSCLC that is active but no longer recruiting, run by Monte Rosa Therapeutics. The registered enrollment target is 174 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (71% lower). The trial reports 17 study locations across 13 states.

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The verdict

NCT05546268, a Phase 1 study of Prostate Cancer and NSCLC, is active but no longer recruiting, sponsored by Monte Rosa Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
174 participants
Enrollment target
17
Study locations

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 Studied

Prostate Cancer NSCLC DLBCL SCLC High Grade Neuroendocrine Cancer 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

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

3 total trials

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What the Registry Record Tells You About NCT05546268

The ClinicalTrials.gov registry entry for NCT05546268 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (71% lower). The listed sponsor is Monte Rosa Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.

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.

NCT05546268 reports 17 study locations spanning 13 distinct geographic areas - top geographies include Texas, Michigan, New York.

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.

What interventions are being tested in trial NCT05546268?

The interventions under investigation include: Oral MRT-2359 (DRUG).

Who is sponsoring clinical trial NCT05546268?

This trial is sponsored by Monte Rosa Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.