A Multicenter, Single Arm, Open-label, Dose-escalation Phase 2 Study of JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM) After Surgery and Concomitant Radio-chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence and Grade of Participants with Adverse Events or Serious Adverse Events
研究概览
简要总结
This study was designed to evaluate the safety, tolerability, efficacy and pharmacokinetics of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and concomitant radio-chemotherapy.
详细描述
This is a multicenter, single arm, open-label, dose-escalation phase 2 study of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM) after surgery and concomitant radio-chemotherapy Patients will receive JK-1201I combined with temozolomide until disease progression.
The primary objective of this study is to assess the safety of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and concomitant radio-chemotherapy.
The secondary objectives of the study are to further evaluate the efficacy and pharmacokinetic profiles of JK-1201I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose Escalation Cohort
Participants will receive JK-1201I as an intravenous (IV) infusion at each 14-day cycle (Q2W) until a treatment discontinuation criterion is met as specified in the protocol. Escalating doses of JK-1201I will be evaluated by the traditional 3+3 design.
Temozolomide will be administered per drug label.
干预措施: JK-1201I (Drug)
Dose Escalation Cohort
Participants will receive JK-1201I as an intravenous (IV) infusion at each 14-day cycle (Q2W) until a treatment discontinuation criterion is met as specified in the protocol. Escalating doses of JK-1201I will be evaluated by the traditional 3+3 design.
Temozolomide will be administered per drug label.
干预措施: Temozolomide (TMZ) (Drug)
Dose Expansion Cohort
Participants will receive JK-1201I as an intravenous (IV) infusion as the recommended Phase 2 dose at each 14-day cycle (Q2W) until a treatment discontinuation criterion is met as specified in the protocol.
Temozolomide will be administered per drug label.
干预措施: JK-1201I (Drug)
Dose Expansion Cohort
Participants will receive JK-1201I as an intravenous (IV) infusion as the recommended Phase 2 dose at each 14-day cycle (Q2W) until a treatment discontinuation criterion is met as specified in the protocol.
Temozolomide will be administered per drug label.
干预措施: Temozolomide (TMZ) (Drug)
结局指标
主要结局
Incidence and Grade of Participants with Adverse Events or Serious Adverse Events
时间窗: From the date of first dose to the end of safety follow-up; Up to 12 months.
Adverse Events (AEs) or Serious Adverse Events (SAEs) are assessed based on NCI CTCAE v5.0.
次要结局
- Progression-free Survival (PFS) Assessed by Investigators(From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to 12 months.)
- Overall survival (OS)(From the date of randomization to the date of death due to any cause; Up to 12 months.)
- Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for JK-1201I, Irinotecan, SN38 and SN38G(Up to 6 months.)
- Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G(Up to 6 months.)