Phase 1 Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China

• Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no effective therapy.
• Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.
• Life expectancy of at least 12 weeks.
• No immuno deficiency.

• Adequate organ system function, defined as follows:

  • Absolute neutrophil count (ANC) ≥1.5 x 10**9/L
  • Platelets ≥100 x 10**9/L
  • Hemoglobin ≥10 g/dL
  • Total bilirubin ≤1.5 times the upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5x the upper limit of normal (ULN) if no liver involvement or ≤2.5x the upper limit of normal with liver involvement.
  • Creatinine ≤ 1.5 x ULN.
• At least 4 weeks or 5 half-life after receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization.
• Willingness and ability to comply with trial and follow-up procedures.
• Ability to understand the nature of this trial and give written informed consent.

Exclusion Criteria:

• Not recovered from prior anti-cancer therapy or surgery.
• Have taken strong cytochrome P450 3A4 inhibitors or inducers in the last 2 weeks.
• Concomitant use of drugs with a risk of causing prolonged corrected QT interval and/or Torsades de Pointes.
• Patients with a history of intolerance to, or significant toxicity with, VEGFR tyrosine kinase inhibitor(s) (TKI).
• Females who are pregnant or breastfeeding.
• Those in reproductive ages who refuse to use contraception.
• Those with concurrent condition(e.g. psychological, neuronal, cardiovascular, respiratory conditions or infections) that in the investigator's opinion would jeopardize compliance with the protocol.
• Patients with known central nervous system (CNS) metastases.
• Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082 (X-82).
• Patients with known GI disorders such as vomiting, diarrhea.
• Patients who are hepatitis B virus positive.
• Drug abuser.