A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations

Inclusion Criteria

• ≥ 18 years or legal adult.
• Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21.
• Has at least 1 measurable target extracranial lesion according to RECIST v1.1.
• Eastern Cooperative Oncology Group Performance Status ≤ 1.
• Has a life expectancy of ≥ 3 months.
• Has adequate hematologic, hepatic, and renal function.
• The above are a summary; other Inclusion Criteria details may apply.

Exclusion Criteria

• History of any concurrent malignancy within the previous 2 years.
• Known other oncogenic driver alterations (eg, moderate or high MET amplification) or histological transformation (eg, to small cell carcinoma, etc.).
• Unresolved toxicities from prior therapies.
• Any significant and uncontrolled medical condition, such as infection.
• Active or history of interstitial lung disease from any cause
• Clinically significant cardiovascular event within 6 months or significant history of major organ.
• The above are a summary; other Exclusion Criteria details may apply.