Phase 1 Safety, Tolerability, and Pharmacokinetic 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
- 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
- Willingness and ability to comply with trial and follow-up procedures.
- Ability to understand the nature of this trial and give written informed consent.
- 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.