MGY825 / Non Small Cell Lung Cancer · Phase 1 Trial

Study of MGY825 in Patients With Advanced Non-small Cell Lung Cancer

ClinicalTrials.gov · September 4, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 trial registry record for MGY825, a novel agent in advanced non-small cell lung cancer, with 41 actual participants enrolled. No efficacy or outcome results are reported in this registry entry; the study was terminated and registered only planned endpoints (safety, tolerability, dose intensity) over 28 months.

What was studied

Phase 1, Interventional, Non Randomized, Single Group, Open label, Treatment purpose. Non-small Cell Lung Cancer; age from 18 Years; to 100 Years. Intervention: Dose escalation; Dose expansion group 1; Dose expansion group 2. n = 41. 15 sites across 6 countries.

Key findings

Safety

This is a registry record only; no results, outcome data, or adverse event frequencies are reported.

Who this may help

This Phase 1 record documents a terminated study and does not provide efficacy or safety results for clinical decision-making. Clinicians should await peer-reviewed publication or updated registry results before considering MGY825 for patient care.

Plain-language summary

Phase 1 safety and tolerability study in advanced NSCLC with actual enrollment of 41 participants; no efficacy results reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (assessed at 28 months); Frequency of dose interruptions and reductions (assessed at 28 months); Dose intensity (assessed at 28 months); Incidence and nature of dose limiting toxicities (DLTs) during the first 28 days of treatment with the study drug (assessed at 28 days)

DesignPhase 1, Interventional, Non Randomized, Single Group, Open label, Treatment purpose

PopulationNon-small Cell Lung Cancer; age from 18 Years; to 100 Years

Sample size41

InterventionDose escalation; Dose expansion group 1; Dose expansion group 2

Setting15 sites across 6 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment41

PhasePHASE 1

Primary endpoint duration (safety assessment)28 months

DLT assessment window28 days

Clinical bottom line

Caveats

This is a registry record only; no results, outcome data, or adverse event frequencies are reported.
Study is terminated; reasons for termination not stated in the source.
No comparator arm or control group.
No efficacy endpoints (tumor response, survival) are mentioned in this Phase 1 registration.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1 interventional design appropriate for safety; single-agent study.

Directness

moderate

Direct measurement of AEs, SAEs, DLTs, and dose intensity in target population.

Consistency

insufficient

No comparator or control arm; single-arm safety study.

Risk of bias

insufficient

Registry record does not report blinding, allocation concealment, or analysis methods.

Sample adequacy

moderate

41 participants enrolled; adequate for Phase 1 dose-escalation and safety assessment.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05275868). This is a study registration, not published results. Lead sponsor: Novartis Pharmaceuticals. Recruitment status: TERMINATED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 41 participants (ACTUAL). Conditions: Non-small Cell Lung Cancer. Interventions: DRUG: MGY825. Primary outcome measures: 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. Brief summary: Study of MGY825 single agent in adult patients with advanced non-small cell lung cancer.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

MGY825NCT05275868Non Small Cell Lung CancerNovartis Pharmaceuticals