Study of the Combination of CM082 With Everolimus in Patients With mRCC

• Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma
• Progressed on at least one standard therapy
• Measurable disease per Recist1.1
• Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1
• Life expectancy of at least 12 weeks
• No abnormal bone marrow function

• Adequate heart, lung, liver, kidney organ system functions, and meet the following requirements:

  • 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 ≤5x the upper limit of normal with liver involvement.
  • Creatinine ≤ 1.5 x ULN
  • Urine protein \<1+
  • QTcF \< 450 ms
  • LVEF ≥ 50%
• At least 4 weeks after receiving cancer therapy (i.e., chemotherapy, radiation therapy, biologic therapy, hormonal therapy); 3 months after surgery and recovered
• 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:

• Currently receiving anti-cancer treatment
• Other tumors in addition to renal cell carcinoma
• 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) or everolimus
• 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 or everolimus
• Patients with known severe lung disorders such as asthma, chronic obstructive pulmonary disease (COPD)
• Patients who are HIV positive
• Drug or alcohol abuser