A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors

Inclusion Criteria

• males or females of any race>(=)18 years age.
• Histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are without standard treatment options (part 1). Pathologically confirmed locally advanced or metastatic solid tumors with KRAS G12C mutation as determined by a test that has been approved by FDA or local health authority (part 2&3).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy>(=)12 weeks.
• Adequate organ and marrow function.
• Measurable or evaluable disease.

Exclusion Criteria

• Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum of 3 weeks, before the first dose.
• Toxicities from previous anti-cancer therapy that have not recovered as required.
• Brain metastatic disease, spinal cord compression, or leptomeningeal carcinomatosis.
• Active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV):
• Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while in this study or within 3 months after the last dose.
• Male subjects who plan to father a child while enrolled in the study or within 3 months after the last dose.
• Received prior treatment with a PIM kinase inhibitor.