Viewing Study NCT05275868



Ignite Creation Date: 2024-05-06 @ 5:21 PM
Last Modification Date: 2024-10-26 @ 2:27 PM
Study NCT ID: NCT05275868
Status: RECRUITING
Last Update Posted: 2024-02-26
First Post: 2022-02-24

Brief Title: Study of MGY825 in Patients With Advanced Non-small Cell Lung Cancer
Sponsor: Novartis Pharmaceuticals
Organization: Novartis

Study Overview

Official Title: An Open-label Phase I Dose Escalation Expansion Study of MGY825 in Adult Patients With Advanced Non-small Cell Lung Cancer
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 will investigate the safety and tolerability of MGY825 in adult patients with advanced NSCLC harboring NFE2L2 or KEAP1 or CUL3 NFE2L2KEAP1CUL3 mutations Patient enrollment will be based on locally available test results of mutation status

An exploratory assessment on the effect of food may be investigated during the dose escalation part

The dose expansion part will assess 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 NFE2L2KEAP1CUL3 mutations enrolled based on locally available test results of mutation status

Group 2 Patients with advanced NSCLC irrespective of prior knowledge of NFE2L2KEAP1CUL3 mutational status

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2021-006793-22 EUDRACT_NUMBER None None