Status:
NOT_YET_RECRUITING
Phase 2 Clinical Trial of KH617
Lead Sponsor:
Sichuan Honghe Biotechnology Co., Ltd.
Conditions:
Recurrent Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and safety of KH617 for injection in combination with temozolomide versus investigator's choice therapy or KH617 monotherapy for recurrent glioblastoma
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Pregnant or breastfeeding women, or women or men who are planning to have children.
- 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.
- 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.
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- 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.
- Significant active bleeding within 6 months before the first dose.
- Newly diagnosed thromboembolic events requiring treatment within 6 months before the first dose.
- 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.
- Patients who have received allogeneic cell or solid organ transplantation.
- Active infection requiring systemic therapy.
- Known history of psychotropic substance abuse, alcoholism, or drug abuse.
- Other circumstances that the researcher deems unsuitable for participation in this clinical trial.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07138001
Start Date
August 1 2025
End Date
December 1 2030
Last Update
August 22 2025
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