Study of Oral MRT-2359 in Selected Cancer Patients
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Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
174estimated
Sites
17
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-10-12 | actual | When the study began enrolling |
| Primary completion | May 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Nov 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-09-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
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
- Drug: Oral MRT-2359
- Drug: Oral MRT-2359
- Drug: Oral MRT-2359
- Drug: Oral MRT-2359
- Drug: Oral MRT-2359
- Drug: Oral MRT-2359
Primary outcomes
what the primary-completion date above is the date OFPhase 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
measured 28 days
Phase 2 Evaluates preliminary anti-tumor activity of MRT-2359 by overall response rate (ORR) as determined by RECIST 1.1
measured 56 days (up to approximately 24 months from screening to end of study participation
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