NCT05546268

Study of Oral MRT-2359 in Selected Cancer Patients

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Monte Rosa Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Phase 1/2, open-label, multicenter, dose escalation and expansion study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary clinical activity of MRT-2359 in patients with previously treated selected solid tumors, including lung cancer (NSCLC and SCLC), high-grade neuroendocrine cancer of any primary site, and DLBCL. * The primary aim of Phase 1 part is safety, tolerability, MTD and/or RP2D of MRT-2359. * The primary aim of Phase 2 part is assessment of preliminary anti-tumor activity of MRT-2359.

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

Type	Name	Description
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.
DRUG	Oral MRT-2359	Orally administered tablets of MRT-2359 in conjunction with orally administered enzalutamide.

Timeline

• Start date: 2022-10-12
• Primary completion: 2026-05-01
• Completion: 2027-11-01
• First posted: 2022-09-19
• Last updated: 2026-03-03

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study