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NCT05275868 (MGY825 in advanced Non-small Cell Lung Cancer): BVCT ex-ante prediction vs. reported outcome

On 2 Jul 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 4 Feb 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably significant (yet moderate) and commercially TBD.

Clinical Trial

NCTID
NCT05275868
Drug Name
MGY825
Drug MoA
anti-NFE2L2, anti-KEAP1, anti-CUL3 trispecific inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
advanced Non-small Cell Lung Cancer
Human Patients
41
Sponsor
Novartis
Phase
Phase 1

Prediction of , index 1656

Prospective Prediction
Prediction Index
1656
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS)
Technical Prediction
partial SUCCESS (statistically significant yet moderate clinical benefit in ORR/PFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
582 days in advance
Readout Data Interpretation
Novartis discontinued its further development for business reasons without safety concerns probably due to moderate early signal in ORR aligned with our prediction of moderate ORR
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably significant (yet moderate) and commercially TBD
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
An Open-label, Phase I, Dose Escalation, Expansion Study of MGY825 in Adult Patients With Advanced Non-small Cell Lung Cancer
Phase
Phase 1
Status
Terminated
Enrollment
41
Lead sponsor
Novartis Pharmaceuticals
Conditions
Non-small Cell Lung Cancer
Interventions
DRUG: MGY825
Design
Non randomized · Single group · None
Primary purpose
Treatment
Start
2022-10-05
Primary completion
2025-10-13
Completion
2025-10-13
Primary outcomes
  • Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (28 months)
  • Frequency of dose interruptions and reductions (28 months)
  • Dose intensity (28 months)
  • Incidence and nature of dose limiting toxicities (DLTs) during the first 28 days of treatment with the study drug (28 days)

NCT05275868 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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