A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors
Trial Parameters
Brief Summary
This is a Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered as Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors
Eligibility Criteria
Inclusion Criteria: 1. males or females of any race\>(=)18 years age. 2. 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). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Life expectancy\>(=)12 weeks. 5. Adequate organ and marrow function. 6. Measurable or evaluable disease. Exclusion Criteria: 1. 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. 2. Toxicities from previous anti-cancer therapy that have not recovered as required. 3. Brain metastatic disease, spinal cord compression, or leptomeningeal carcinomatosis. 4. Active infection including hepatitis B, hepatitis C, and human immunodeficiency virus