A Phase 2, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma.
详细描述
This is a phase 2 study designed to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in subjects with recurrent glioblastoma.
A total of 20 patients will be enrolled in the study and administered bevacizumab GX-I7. The study treatment will be continued for up to 6 cycles or until a progression of disease or unacceptable toxicity is confirmed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years
- •Histologically diagnosed glioblastoma patients who have been confirmed the progression of disease after attempting standard therapy (RT/CCRT and/or adjuvant chemotherapy (TMZ))
- •Karnofsky Performance Status; KPS ≥ 60 or ECOG status 0-2
- •Life expectancy > 12 weeks
- •Adequate hematologic and end organ function
排除标准
- •Malignancies other than disease under study within 5 years prior to the first dose of study drug
- •Subjects who have received bevacizumab or other VEGF inhibitors prior to study participation
- •Body Mass Index (BMI) ≥ 30 kg/m2
- •Subjects confirmed intracranial hemorrhage with non-contrast CT or MRI
- •Clinically significant cardiovascular disease
- •History of arterial or venous thromboembolism 6 months prior to study participation
- •Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg with appropriate antihypertensive therapy)
- •History of hypertensive crisis or hypertensive encephalopathy
- •Subjects receiving therapeutic anticoagulation (except low molecular weight heparin or warfarin)
- •Pregnancy or breastfeeding.
- •Subjects with active virus infection
- •Subjects with autoimmune disease/ syndromes
- •Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study
- •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •Severe infections during the screening period, including but not limited to complications of infection, bacteremia or severe pneumonia
- •Prior allogeneic bone marrow transplantation or prior solid organ transplantation
研究组 & 干预措施
GX-I7 and bevacizumab
Bevacizumab at a dose of 10 mg/kg intravenously, and GX-I7 intramuscularly.
干预措施: Bevacizumab (Drug)
GX-I7 and bevacizumab
Bevacizumab at a dose of 10 mg/kg intravenously, and GX-I7 intramuscularly.
干预措施: GX-I7 (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: From the initiation of study treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Progression free survival (PFS) by iRANO criteria
Overall survival (OS)
时间窗: From the initiation of study treatment until the date of death from any cause, assessed up to 24 months.
Overall survival (OS)
次要结局
- ORR (Objective response rate)(From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months.)
- DOR (Duration of response)(From the date of complete response or partial response until the date of first documented progression, assessed up to 24 months.)
- DCR (Disease control rate)(From the date of complete response, partial response, or stable disease until the date of first documented progression, assessed up to 24 months.)
- Incidence of adverse events (AEs)(Through study completion, an average of 1 year)
- Immunogenicity (ADA)(Day 1 and Day 43 of each cycle (8-week interval))
- Immunogenicity (neutralizing antibody)(Day 1 and Day 43 of each cycle (8-week interval))
- Absolute counts and ratios of immune cell subtypes(Day 1 and Day 29 of each cycle (8-week interval))