Clinical Trial

Study of Oral MRT-2359 in Selected Cancer Patients

Active, Not Recruiting Phase 1/2
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Record status
This record was last updated March 3, 2026 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 29 amendments
This ClinicalTrials.gov record has been amended 29 times since 2022-09-16; most recent amendment 2026-02-27.
Status change: Recruiting → Active, Not Recruiting 2026-02-27
Status change: Not Yet Recruiting → Recruiting 2022-10-27
Trial Details
NCT Number NCT05546268
Lead Sponsor Monte Rosa Therapeutics, Inc
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
Enrollment 174 participants
Start Date 2022-10-12
Primary Completion 2026-05 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-03-03