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

Eligibility 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.