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

Stopped early · Phase 1

Conditions studied: Non-small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT05275868

Run by

Novartis Pharmaceuticals

People needed

41

Starts

2022-10-05

Expected to finish

2025-10-13

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent must be obtained prior to participation in the study.
• Dose escalation and dose expansion group 1:
• Patients with histologically or cytologically confirmed diagnosis of advanced (metastatic or unresectable) NFE2L2/KEAP1/CUL3 mutant NSCLC. Local data confirming the NFE2L2/KEAP1/CUL3 mutation status in tissue must be available for enrollment.
• Dose expansion group 2:
• Patients with histologically or cytologically confirmed diagnosis of advanced (metastatic or unresectable) NSCLC irrespective of NFE2L2/KEAP1/CUL3 mutation status.
• All patients:
• Patients must have progressed after 1 platinum-based chemotherapy regimen and PD-(L)1 antibody therapy either sequentially or concurrent with chemotherapy, where indicated, for Stage IV NSCLC.
• Patients treated with neo-adjuvant / adjuvant platinum-based therapy that progressed within 6 months of treatment are permitted to participate.
• Prior therapy with VEGF/VEGFR targeting agents is permitted. Prior treatment with approved targeted drugs (e.g., EGFRi, ALKi, METi) is mandatory in patients with NSCLC whose tumor bears actionable mutations.
• 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.

You may not qualify if…

• Having out of range laboratory values defined as:
• Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min Total bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN ALT > 3 x ULN AST > 3 x ULN ANC < 1.0 x 109/L Platelet count < 75 x 109/L Hemoglobin < 9 g/dL
• Impaired cardiac function or clinically significant cardiac disease, including any of the following:
• Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥2), uncontrolled hypertension or clinically significant arrhythmia.
• QTcF > 470 msec on screening ECG or congenital long QT syndrome. Acute myocardial infarction or unstable angina pectoris < 3 months prior to study entry.
• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Wash U School of Medicine — St Louis, Missouri, United States
• NYU School of Medicine — New York, New York, United States
• Memorial Sloan Kettering Onc. Dept — New York, New York, United States
• Memorial Sloan Kettering — New York, New York, United States
• Uni Of TX MD Anderson Cancer Cntr — Houston, Texas, United States
• Novartis Investigative Site — Frankfurt am Main, Hesse, Germany
• Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Chuo Ku, Tokyo, Japan
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Geneva, Switzerland
• Novartis Investigative Site — Sankt Gallen, Switzerland

Full record on ClinicalTrials.gov

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