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Not yet recruiting NCT07138001

Phase 2 Clinical Trial of KH617

Phase II Interventional Recurrent Glioblastoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KH617+TMZ, KH617, TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16.
Who it may be relevant to
Registry conditions: Recurrent Glioblastoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Controlled, Open-label, Multicenter Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of KH617 in Combination With Temozolomide Versus Investigator's Choice Treatment or KH617 Monotherapy for Recurrent Glioblastoma

Overview

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

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

Primary outcome measures

  • ORR [Time frame: 54 weeks]
  • PFS-6 [Time frame: 54 weeks]
  • TEAE [Time frame: 54 weeks]
Secondary outcome measures (4)
  • DOR [Time frame: 54 weeks]
  • PFS [Time frame: 54 weeks]
  • OS [Time frame: 54 weeks]
  • EORTC QLQ-BN20 [Time frame: 54 weeks]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07138001 · KH617-30201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗