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NCT05546268 (MRT-2359 in MYC-driven advanced solid tumours): BVCT ex-ante prediction vs. reported outcome

On 30 Sep 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 20 Mar 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05546268
Drug Name
MRT-2359
Drug MoA
anti-GSPT1 molecular glue degrader
Drug Modality
molecular glue degrader
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
MYC-driven advanced solid tumours
Human Patients
174
Sponsor
Monte Rosa Therapeutics
Phase
Phase 1 Phase 2

Prediction of , index 1249

Prospective Prediction
Prediction Index
1249
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically maybe significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
537 days in advance
Readout Data Interpretation
MRT2359 achieved 8% ORR (1/13) for MYC-positive patients and 3% ORR (1/37) for all patients; further development in SCLC; NSCLC; NE tumors discontinued due to low efficacy except for AR-resistant CRPC
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
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
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
174
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
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
Design
Non randomized · Single group · None
Primary purpose
Treatment
Start
2022-10-12
Primary completion
2026-05
Completion
2027-11
Primary outcomes
  • 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)

NCT05546268 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials