BA3011-002

• Age ≥ 18 years
• Patients must have measurable disease:
  • Have histologically or cytologically confirmed locally advanced unresectable or metastatic NSCLC.
  • Have prior disease progression on or after receiving an approved PD-1/L1, EGFR or ALK inhibitor (either monotherapy or in combination with another therapy).
• Patients must have:
  • Completed (and recovered from treatment-related toxicities) any prior treatment with radiotherapy, chemotherapy, and/or treatment with other investigational anticancer agents at least 5 half-lives, or 2 weeks, prior to first study dose, or biologics (such as a monoclonal antibody [mAb]) at least 4 weeks prior to first study dose. Exceptions are bisphosphonates, denosumab and gonadotropin-releasing hormone agonist or antagonist.
  • Completed any prior treatment with nitrogen mustard agents, melphalan, or carmustine (BCNU) therapy at least 6 weeks prior to first study dose.
  • Received any prior autologous hematopoietic stem cell infusion at least 8 weeks prior to first study dose.
• Adequate renal function
• Adequate liver function
• Adequate hematological function
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy of at least three months

• Patients must not have clinically significant cardiac disease.
• Patients must not have known non-controlled CNS metastasis.
• Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
• Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
• Patients must not have had major surgery within 4 weeks before first BA3011
• Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
• Patients must not be women who are pregnant or breast feeding.

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