A Phase I, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications
试验速览
- 阶段
- 1 期
- 入组人数
- 193
- 试验地点
- 16
- 主要终点
- Dose escalation part： Safety and tolerability of SHR-1701 in advanced malignancies.
研究概览
简要总结
The main purpose of this study is to assess the safety and tolerability of SHR-1701 at different dose levels. Study consists of dose-escalation part and an expansion part in subjects with metastatic or locally advanced solid tumors.
详细描述
This is a Phase I, open-label, multiple-ascending dose trial. Study consists of dose-escalation part in subjects with metastatic or locally advanced solid tumors, and expansion part with selected indications.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide signed informed consent form, and able to comply with all procedures.
- •Histologically or cytologically proven metastatic or locally advanced solid tumors.
- •Male or female subjects aged 18-75 years.
- •Life expectancy >= 12 weeks as judged by the Investigator.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.
- •Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •Adequate hematological, hepatic and renal function as defined in the protocol
- •Other protocol-defined inclusion criteria could apply.
排除标准
- •Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor.
- •Anticancer treatment within 28 days before the first dose of study drug.
- •Major surgery within 28 days before start of trial treatment.
- •Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.
- •With any active autoimmune disease or history of autoimmune disease.
- •With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention.
- •Clinically significant cardiovascular and cerebrovascular diseases
- •History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy.
- •Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded.
- •Receipt of any organ transplantation, including allogeneic stem-cell transplantation
- •Other protocol-defined exclusion criteria could apply
研究组 & 干预措施
SHR-1701
intravenous infusion
干预措施: SHR-1701 (Drug)
结局指标
主要结局
Dose escalation part： Safety and tolerability of SHR-1701 in advanced malignancies.
时间窗: Up to 3/4 weeks.
Number of Subjects who occurs dose-limiting toxicity (DLTs).
Clinical expansion Part: Objective Response Rate（ORR）
时间窗: Up to 6 weeks
ORR is define as the percentage of participants in the analysis population who havea Complete Response(CR:Disappearance of all target lesions)or a Partial Response(PR :30% decrease in the sum of diameter of target lesions) per RECIST 1.1.
次要结局
- Clinical expansion Part: Safety of SHR-1701(Up to 4 weeks after last treatment)
- Clinical expansion Part: Disease Control Rate(DCR) per RECIST1.1(Up to 6 weeks)
- Clinical expansion Part: Duration of Response （DOR）per RECIST1.1(Up to 6 weeks)
- Clinical expansion Part:Progression-free survival(PFS) per RECIST1.1(12months (anticipated))