Phase 2 Clinical Trial of KH617

Prior treatment

• Patients who have received the following treatments before enrollment should be excluded:
  • Patients who have received surgery, chemotherapy, targeted and immune drug therapy, iodine internal radiation, or radiotherapy within 4 weeks or 5 half-lives (whichever is shorter) before enrollment or who plan to receive radiotherapy during the trial.
  • Patients who had undergone intracranial lesion biopsy within 7 days before enrollment.
  • Received other clinical research drugs or treatments within 4 weeks before enrollment.
  • Received treatment with traditional Chinese medicine or Chinese patent medicine with anti-tumor effects within 1 week before enrollment.
• History of central nervous system hemorrhage/infarction, such as ischemic/hemorrhagic stroke, within 6 months before enrollment.
• Significant active bleeding within 6 months before the first dose.
• Newly diagnosed thromboembolic events requiring treatment within 6 months before the first dose.
• Patients who have received allogeneic cell or solid organ transplantation.

Other illness

• Known history of unstable angina, myocardial infarction, or congestive heart failure within the past 6 months or clinically significant arrhythmia requiring antiarrhythmic therapy.
• Poorly controlled high blood pressure or diabetes.
• Patients at risk for active autoimmune disease or those with a history of autoimmune disease that may involve the central nervous system.
• Pulmonary disease defined as grade ≥3 according to NCI-CTCAE v5.0.
• Other malignant tumors diagnosed within 5 years before the first dose.
• Known allergy to any component of KH617.
• Positive human immunodeficiency virus (HIV) antibodies, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, and the presence of untreated or currently treated tuberculosis in the patient.
• Active infection requiring systemic therapy.
• Known history of psychotropic substance abuse, alcoholism, or drug abuse.

Other

• Pregnant or breastfeeding women, or women or men who are planning to have children.
• Uncontrolled pleural effusion, pericardial effusion, or ascites.
• Other circumstances that the researcher deems unsuitable for participation in this clinical trial.

• Male or female,age≥18 years old.
• Life expectancy of at least 3 months.
• Glioblastoma confirmed by histopathology.
• Glioblastoma that recurred for the first time after failure of standard treatment.
• Patient has at least one measurable lesion by iRANO.
• MGMT promoter is unmethylated.
• KPS≥ 60.
• Adequate organ and bone marrow reserve function.