Phase 2 Clinical Trial of KH617

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Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female,age≥18 years old. 2. Life expectancy of at least 3 months. 3. Glioblastoma confirmed by histopathology. 4. Glioblastoma that recurred for the first time after failure of standard treatment. 5. Patient has at least one measurable lesion by iRANO. 6. MGMT promoter is unmethylated. 7. KPS≥ 60. 8. Adequate organ and bone marrow reserve function.

Exclusion Criteria:

1. Pregnant or breastfeeding women, or women or men who are planning to have children. 2. Patients who have received the following treatments before enrollment should be excluded: 1. 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. 2. Patients who had undergone intracranial lesion biopsy within 7 days before enrollment. 3. Received other clinical research drugs or treatments within 4 weeks before enrollment. 4. Received treatment with traditional Chinese medicine or Chinese patent medicine with anti-tumor effects within 1 week before enrollment. 3. History of central nervous system hemorrhage/infarction, such as ischemic/hemorrhagic stroke, within 6 months before enrollment. 4. Known history of unstable angina, myocardial infarction, or congestive heart failure within the past 6 months or clinically significant arrhythmia requiring antiarrhythmic therapy. 5. Poorly controlled high blood pressure or diabetes. 6. Uncontrolled pleural effusion, pericardial effusion, or ascites. 7. Patients at risk for active autoimmune disease or those with a history of autoimmune disease that may involve the central nervous system. 8. Pulmonary disease defined as grade ≥3 according to NCI-CTCAE v5.0. 9. Significant active bleeding within 6 months before the first dose. 10. Newly diagnosed thromboembolic events requiring treatment within 6 months before the first dose. 11. Other malignant tumors diagnosed within 5 years before the first dose. 12. Known allergy to any component of KH617. 13. 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. 14. Patients who have received allogeneic cell or solid organ transplantation. 15. Active infection requiring systemic therapy. 16. Known history of psychotropic substance abuse, alcoholism, or drug abuse. 17. Other circumstances that the researcher deems unsuitable for participation in this clinical trial.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07138001
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sichuan Honghe Biotechnology Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Wenbin Li
Principal Investigator Affiliation	Beijing Titan Hospital,Capital Medical University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Recurrent Glioblastoma

Arms & Interventions

Arms

Experimental: KH617+TMZ

KH617： 33mg/kg intravenous infusion, every 4 weeks as one cycle. TMZ（5/28）：150~200mg/m2/d, oral, every 4 weeks as one cycle.

Experimental: KH617

KH617： 33mg/kg intravenous infusion, every 4 weeks as one cycle.

Active Comparator: TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16

TMZ（7/7）： 100-150 mg/m2/d，oral, alternating weekly,every 4 weeks as one cycle. Platinum (cisplatin or carboplatin)+VP-16： Cisplatin for injection 80-100mg/m2, divided into 3 days, the dose depends on tolerability, every 4 weeks as one cycle; carboplatin injection 75-100mg/m2/d, continuously administered for 3 days, the dose depends on tolerability, every 4 weeks as one cycle; etoposide injection 100mg/m2/d, continuously administered for 3 days, every 4 weeks as one cycle.

Interventions

Combination Product: - KH617+TMZ

use KH617 and TMZ(5/28) as Combination Product.

Drug: - KH617

Single Clinical trial investigational drug

Drug: - TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16

Comparator product, Two treatment options for physicians and subjects to choose from: 1. use TMZ(7/7) 2. Use Platinum (cisplatin or carboplatin)+VP-16