First-in-human Phase I Study of a Selective c-Met Inhibitor PLB1001

Exclusion Criteria

• •Previous or current treatment with a c-Met inhibitor or HGF-targeting therapy
• •Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any CNS deficits.
• •Clinically significant, uncontrolled heart diseases. Unstable angina History of documented congestive heart failure (New York Heart Association functional classification \> II) Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 140 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 90 mm Hg Arrhythmias
• •Active peptic ulcer disease or gastritis
• •Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
• •Major surgery within 4 weeks prior to starting PLB1001
• •Previous anti-cancer and investigational agents within 4 weeks before first dose of PLB1001. If previous treatment is a monoclonal antibody, then the treatment must be discontinued at least 6 weeks before first dose of PLB1001.
• •Pregnant or nursing women
• •Involved in other clinical trials \< 30 days prior to Day 1