Phase 2 Clinical Trial of KH617

Официальное название

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

Обзор

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

Вмешательства

• Комбинированный продукт KH617+TMZ
  use KH617 and TMZ(5/28) as Combination Product.
• Препарат KH617
  Single Clinical trial investigational drug
• Препарат 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

Первичные конечные точки

• ORR [Срок оценки: 54 weeks]
• PFS-6 [Срок оценки: 54 weeks]
• TEAE [Срок оценки: 54 weeks]

Вторичные конечные точки (4)

• DOR [Срок оценки: 54 weeks]
• PFS [Срок оценки: 54 weeks]
• OS [Срок оценки: 54 weeks]
• EORTC QLQ-BN20 [Срок оценки: 54 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07138001 · KH617-30201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗