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MRT-2359

Phase 1

NSCLC | Small molecule | Oncology |Monte Rosa Therapeutics, Inc.|Last Updated: Mar 3, 2026

Success Probability
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Market & Valuation
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment174
FDA Designations
No designations recorded
Clinical trial landscape

MRT-2359 · 1 trial · 8 indications

Phase 1 1
NCT05546268Study of Oral MRT-2359 in Selected Cancer PatientsNSCLC
ACTIVE NOT_RECRUITING174 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC
NCT05546268174
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Study Endpoints
Primary Endpoints
Phase 1 Evaluates safety and tolerability of MRT-2359 over a 28-day cycle by the occurrence and frequency of dose limiting toxicities (DLTs) for determination of the MTD and/or RP2D
28 days
Phase 2 Evaluates preliminary anti-tumor activity of MRT-2359 by overall response rate (ORR) as determined by RECIST 1.1
56 days (up to approximately 24 months from screening to end of study participation
Secondary Endpoints
Phase 1 safety and tolerability of MRT-2359 (orally over a 28-day cycle) by the nature, incidence, and severity of all treatment-emergent adverse events (TEAEs), including treatment-related TEAEs and serious adverse events (SAEs)
18 months
Phase 1 preliminary anti-tumor activity: ORR (RECIST 1.1/Revised Response Criteria for Malignant Lymphoma),duration of response for complete response(CR)/partial response(PR), disease control rate, progression-free survival, overall survival
18 months
Phase 1 Dose Escalation characterizes the PK profile of MRT-2359 by standard primary PK parameters including, but not limited to, AUC, Cmax, tmax, and t1/2
28 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1 Dose EscalationEXPERIMENTALPatients with NSCLC, SCLC, high-grade neuroendocrine cancer of any primary site, any solid tumors with L-MYC or N-MYC amplification, or DLBCL
Phase 2 Expansion - NSCLCEXPERIMENTALPatients with NSCLC with high or low L-MYC or N-MYC expression
Phase 2 Expansion - SCLCEXPERIMENTALPatients with SCLC
Phase 2 Expansion - L-MYC or N-MYC amplified solid tumorsEXPERIMENTALPatients with L-MYC or N-MYC amplified solid tumors
Phase 2 Expansion - HR-positive, HER2-negative breast cancerEXPERIMENTALPatients with HR-positive, HER2-negative breast cancer in combination with fulvestrant
Phase 2 Expansion - Prostate CancerEXPERIMENTALPatients with prostate cancer in combination with enzalutamide
Interventions
NameTypeDescription
Oral MRT-2359DRUGOrally administered tablets of MRT-2359.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Phase 1 enrollment population: * NSCLC * SCLC * High-grade neuroendocrine cancer of any primary site * Any solid tumors with L-MYC or N-MYC amplification * DLBCL Phase 2 enrollment population: * Any solid tumors with L-MYC or N-MYC amplification * NSCLC with high or low L-MYC or N-MYC expression ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05546268primaryCompletionDate: changed
LOWMay 24, 2026NCT05546268studyFirstPostDate: changed