NCT05275868

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

An Open-label, Phase I, Dose Escalation, Expansion Study of MGY825 in Adult Patients With Advanced Non-small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Study of MGY825 single agent in adult patients with advanced non-small cell lung cancer.

Detailed description

First in human, phase I, multicenter, open-label study of MGY825 single agent with a dose escalation and a dose expansion in adult patients with advanced non-small cell lung cancer (NSCLC). The dose escalation part investigated the safety and tolerability of MGY825 in adult patients with advanced NSCLC harboring NFE2L2, or KEAP1 or CUL3 (NFE2L2/KEAP1/CUL3) mutations. Patient enrollment was based on locally available test results of mutation status. An exploratory assessment on the effect of food could be investigated during the dose escalation part. The dose expansion part assessed the preliminary anti-tumor activity and further assess the safety and tolerability of MGY825 in adult patients with advanced NSCLC divided in two patient groups. Group 1: Patients with advanced NSCLC harboring NFE2L2/KEAP1/CUL3 mutations enrolled based on locally available test results of mutation status. Group 2: Patients with advanced NSCLC irrespective of prior knowledge of NFE2L2/KEAP1/CUL3 mutational status.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	MGY825	investigational drug

Timeline

• Start date: 2022-10-05
• Primary completion: 2025-10-13
• Completion: 2025-10-13
• First posted: 2022-03-11
• Last updated: 2025-11-10

Locations

15 sites across 6 countries: United States, Germany, Japan, South Korea, Spain, Switzerland

Regulatory

• FDA-regulated drug study