NCT02829372终止1 期
A Phase 1, First-in-man, Multicenter, Open-label, Dose-escalation Study of Single-agent GBR 1302 in Subjects With HER2 Positive Cancers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- The relationship of the dose of GBR 1302 with the incidence, nature, and intensity of AEs according to CTCAEv4.03
研究概览
简要总结
The purpose of this study is to determine the safety profile and maximum tolerable dose (MTD) of GBR 1302 monotherapy in subjects with HER2 positive cancers
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Progressive HER2 positive solid tumours (immunohistochemistry [IHC] positive or equivocal) with no available standard or curative treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
排除标准
- •Active infectious disease considered by the Investigator to be incompatible with the protocol.
- •Patients not recovered from any therapy-related toxicities from previous therapies to at least CTCAE ≤ Grade 1 except in case of liver metastases or Gilbert's Syndrome or alopecia.
- •Brain metastases that are symptomatic or untreated or that require current therapy.
- •Previous treatment with immunotherapy within 8 weeks of starting study medication, chemotherapy, radiotherapy, molecular-targeted therapy, or biological therapies (including HER2 directed therapies) within 4 weeks of starting study medication, or hormone therapy within 2 weeks of starting study medication.
- •Use of any investigational drug within the past 4 weeks before start of study medication or concomitantly with this study except for investigational immune-stimulatory therapy (e.g. checkpoint-regulator targeted treatment). The minimum washout period should be 8 weeks before starting the study medication.
研究组 & 干预措施
GBR 1302
Experimental
Dose escalation
干预措施: CD3/HER2 bispecific monoclonal antibody (Drug)
结局指标
主要结局
The relationship of the dose of GBR 1302 with the incidence, nature, and intensity of AEs according to CTCAEv4.03
时间窗: 28 Days
Maximal Tolerated Dose (MTD) of GBR 1302
时间窗: 28 Days
Number of DLTs (dose limiting toxicities) after the first two administrations of study drug (i.e. Cycle 1) in each cohort
次要结局
- Objective Response Rate (ORR) for solid tumors.(2 cycles, 56 days)
- Disease control rate (DCR) for solid tumors(2 cycles, 56 days)
- Duration of disease control (measured from drug start date to the date of disease progression or death for subjects who had CR or PR or SD during treatment).(At least 56 days)
- Maximum Concentration (Cmax) of GBR 1302(28 Days)
- Time to Maximum Concentration (Tmax) of GBR 1302(28 Days)
- Area Under Curve [AUC0-t and AUC0-tau] of GBR 1302(28 Days)
- Immunogenicity of GBR 1302 in terms of ADA formation assessed compared to baseline(28 Days)
研究者
研究点 (8)
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