TERMINATED

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

Conditions

Non-small Cell Lung Cancer non-small cell lung cancer (NSCLC)NFE2L2 NRF2 KEAP1 CUL3 MGY825

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-10-05

Study Completion:2025-10-13

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05275868

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Signed informed consent must be obtained prior to participation in the study. * Dose escalation and dose expansion group 1: * Dose expansion group 2: * All patients: * Presence of at least one measurable lesion according to RECIST v1.1. * Patient must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening and during study treatment. A recent biopsy collected after the last systemic treatment and within 3 months before study entry may be submitted at screening.	* Having out of range laboratory values defined as: * Impaired cardiac function or clinically significant cardiac disease, including any of the following: * Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery) or increasing doses of corticosteroids within 2 weeks prior to study entry. Patients with treated symptomatic brain metastases should be neurologically stable (for 4 weeks post-treatment and prior to study entry) and at a dose of ≤ 10 mg per day prednisone or equivalent for at least 2 weeks before administration of any study treatment. * Known active COVID-19 infection. * Unable or unwilling to swallow capsules as per dosing schedule. Other protocol-defined inclusion/exclusion criteria may apply.

Inclusion Criteria

Exclusion Criteria

* Signed informed consent must be obtained prior to participation in the study.
* Dose escalation and dose expansion group 1:
* Dose expansion group 2:
* All patients:
* Presence of at least one measurable lesion according to RECIST v1.1.
* Patient must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening and during study treatment. A recent biopsy collected after the last systemic treatment and within 3 months before study entry may be submitted at screening.

* Having out of range laboratory values defined as:
* Impaired cardiac function or clinically significant cardiac disease, including any of the following:
* Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery) or increasing doses of corticosteroids within 2 weeks prior to study entry. Patients with treated symptomatic brain metastases should be neurologically stable (for 4 weeks post-treatment and prior to study entry) and at a dose of ≤ 10 mg per day prednisone or equivalent for at least 2 weeks before administration of any study treatment.
* Known active COVID-19 infection.
* Unable or unwilling to swallow capsules as per dosing schedule. Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

United States

Wash U School of Medicine

St Louis, Missouri, 63110

United States

NYU School of Medicine

New York, New York, 10015

United States

Memorial Sloan Kettering Onc. Dept

New York, New York, 10017

United States

Memorial Sloan Kettering

New York, New York, 10017

United States

Uni Of TX MD Anderson Cancer Cntr

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-05

Study Completion Date2025-10-13

Study Record Updates

Study Start Date2022-10-05

Study Completion Date2025-10-13

Terms related to this study

Keywords Provided by Researchers

non-small cell lung cancer (NSCLC)
NFE2L2
NRF2
KEAP1
CUL3
MGY825

Additional Relevant MeSH Terms

Non-small Cell Lung Cancer