A Study of NX-019 in Patients with Advanced, Epidermal Growth Factor Receptor (EGFR) Mutant Cancer

Exclusion Criteria

• •Patients who meet any of the following criteria will be excluded from participation in the study:
• •Known C797X EGFR mutations or 1 or more known secondary drivers of disease.
• •Disease requiring immediate palliative treatment with surgery or radiation therapy.
• •Requirement for greater than 4 mg/day of dexamethasone (or equivalent) for management of CNS metastases.
• •Received systemic anticancer chemotherapy, targeted agents, antibody therapy for cancer, immunotherapy for cancer, hormonal therapy or an investigational agent within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study drug treatment.
• •Major surgery within 3 weeks prior to start of study drug treatment.
• •Radiation therapy within 4 weeks prior to start of study drug treatment.
• •Severe or unstable cardiac conditions within 6 months prior to starting study drug treatment.
• •Severe or unstable medical condition including uncontrolled diabetes or unstable psychiatric condition.
• •Dependent on contact lenses (unable to wear eyeglasses) and unable to comply with ophthalmic guidance.
• •History of interstitial lung disease, radiation pneumonitis which required systemic steroid therapy, or other significant lung disease.
• •Another active malignancy within the previous 2 years except for localized cancers that are not related to the current cancer being treated, are considered cured, and, in the opinion of the Investigator, present a low risk of recurrence.
• •Active infection requiring systemic therapy.
• •Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) (i.e., hepatitis B surface antigen-positive), or hepatitis C virus (HCV) (i.e., detectable HCV ribonucleic acid \[RNA\]).
• •Active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or conditions that may impact drug absorption.
• •Pregnant or breastfeeding.
• •Is using a strong CYP3A inhibitor or inducer, and cannot refrain from use from 7 days prior to the first dose and throughout the study.
• •Is using a proton pump inhibitor and cannot refrain from use from 7 days prior to the first dose and throughout the study.
• •Is using a sensitive substrate of P-gp with a narrow therapeutic window (e.g. digoxin).
• •Any other condition, including significant skin or nail disease, that in the opinion of the Investigator would place the patient at an unacceptable risk or cause the patient to be unlikely to fully participate or comply with study procedures.