NCT07138001尚未招募2 期
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
Sichuan Honghe Biotechnology Co., Ltd.0 个研究点目标入组 60 人开始时间: 2025年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- TEAE
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Adequate organ and bone marrow reserve function.
排除标准
- •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.
- •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 KH
- •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.
研究组 & 干预措施
KH617+TMZ
Experimental
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.
干预措施: KH617+TMZ (Combination Product)
KH617
Experimental
KH617： 33mg/kg intravenous infusion, every 4 weeks as one cycle.
干预措施: KH617 (Drug)
结局指标
主要结局
TEAE
时间窗: 54 weeks
ORR
时间窗: 54 weeks
PFS-6
时间窗: 54 weeks
次要结局
- OS(54 weeks)
- DOR(54 weeks)
- PFS(54 weeks)
- EORTC QLQ-BN20(54 weeks)
研究者
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