🏛️ Verified NIH Record • Updated 2026-02-27

Study of Oral MRT-2359 in Selected Cancer Patients (NCT05546268)

A Phase 1/2 Study of Oral MRT-2359 in Patients With MYC-Driven and Other Selected Solid Tumors Including Lung Cancer and Diffuse B-Cell Lymphoma

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Monte Rosa Therapeutics, Inc

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Honor Health Research Institute — Scottsdale, Arizona

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (17 Sites)

  • Honor Health Research Institute — Scottsdale, Arizona
  • University of California San Diego — San Diego, California
  • Yale University — New Haven, Connecticut
  • University of Kansas Cancer Center — Lawrence, Kansas
  • Dana Farber Cancer Institute — Boston, Massachusetts
  • Henry Ford Cancer Institute — Detroit, Michigan
  • South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids, Michigan
  • Washington University — St Louis, Missouri
  • Memorial Sloan Kettering Cancer Center — New York, New York
  • Columbia University Irving Medical Centre — New York, New York
  • Sarah Cannon Research Institute — Nashville, Tennessee
  • Mary Crowley Cancer Research — Dallas, Texas
  • MD Anderson Cancer Center — Houston, Texas
  • South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas
  • South Texas Accelerated Research Therapeutics (START) Mountain Region — West Valley City, Utah
  • Virginia Cancer Specialists Research Institute — Fairfax, Virginia
  • Fred Hutchinson Cancer Center — Seattle, Washington

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All NSCLC clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗