Study of BEBT-607 Tablets in The Treatment of Advanced or Metastatic Solid Tumors With KRAS G12C Mutation

Exclusion criteria

• ✕. Advanced patients with a short-term risk of life-threatening complications (patients with visceral crisis).
• ✕. Symptomatic or unstable central nervous system(CNS) metastasis, characterized by clinically symptomatic cerebral edema, spinal cord compression, cancerous meningitis, pia meningeal disease, and/or progressive growth. Stable is defined as: 1) seizure-free status continued for \>12 weeks with or without antiepileptic drugs; 2) glucocorticoids is not required; 3) Continuously multiple consecutive imaging examinations (scan interval of at least 8 weeks) showed a stable state.
• ✕. Known impairment of gastrointestinal (GI) function or Gl diseases that may significantly affect the absorption or metabolism of oral drugs.
• ✕. Patients who had major surgery (or planned major surgery during the study period), chemotherapy, radiation therapy, any investigational drug, or other anticancer therapy within 4 weeks prior to study entry.
• ✕. Known or suspected allergic symptoms to any component of BEBT-607 tablets.
• ✕. The patient received the following treatments in the 7 days prior to study beginning and plans to use the following drugs throughout the regimen: drugs known to be potent inhibitors/inducers of cytochrome P450 3A4(CYP3A4), cytochrome P450 2C8(CYP2C8), and cytochrome P450 2D6(CYP2D6); Drugs known to significantly lengthen the QT interval.
• ✕. At rest, QT interval (QTc)\>470msec(female) or \>450msec(male) of Fridericia's mean correction from 3 electrocardiogram (ECG) tests (only retest and take 3 mean corrections if the first ECG indicates QTc\>470msec(female) or \>450msec(male)); A history of long QT syndrome or a proven long QT synthesis Family history: Clinically significant history of ventricular arrhythmias, or current use of antiarrhythmic drugs or implantation of a defibrillation device for the treatment of ventricular arrhythmias.
• ✕. Uncontrolled electrolyte disturbances may affect the effect of QTc protractive drugs (e.g., hypocalcaemia \<1.0mmol/L, hypokalemia \< lower limit of normal).