NCT03871855终止1 期
A Study of SHR-1702 Alone or With Camrelizumab in Participants With Advanced Relapsed/Refractory Solid Tumors
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
- 8
- 试验地点
- 1
- 主要终点
- Number of Participants with DLTs
研究概览
简要总结
The purpose of this study is to evaluate the safety of SHR-1702 monotherapy or in combination with Camrelizumab among advanced solid tumor subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically or cytologically confirmed advanced relapsed/refractory solid tumors
- •Must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- •Have an estimated life expectancy of 12 weeks, in judgement of the investigator；
- •Must have at least 1 measurable lesion assessable using standard techniques by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
- •Adequate hematologic and organ function
- •Signed inform consent form
排除标准
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- •Significant cardiovascular disease
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring
- •History of autoimmune disease.
- •Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
- •Positive test result for human immunodeficiency virus (HIV); Active hepatitis B or hepatitis C
- •Active or untreated central nervous system (CNS) metastases
- •Active infection within 2 weeks
- •History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins
- •Prior allogeneic bone marrow transplantation or solid organ transplant
- •History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
研究组 & 干预措施
C:SHR-1702 and Camrelizumab Dose Escalation
Experimental
SHR-1702 and Camrelizumab given intravenously (IV).
干预措施: SHR-1702 (Drug)
A:SHR-1702 Dose Escalation
Experimental
SHR-1702 given intravenously (IV).
干预措施: SHR-1702 (Drug)
B:SHR-1702 Dose Expansion
Experimental
SHR-1702 given intravenously (IV).
干预措施: SHR-1702 (Drug)
C:SHR-1702 and Camrelizumab Dose Escalation
Experimental
SHR-1702 and Camrelizumab given intravenously (IV).
干预措施: Camrelizumab (Drug)
D:SHR-1702 and Camrelizumab Dose Expansion
Experimental
SHR-1702 and Camrelizumab given intravenously (IV).
干预措施: SHR-1702 (Drug)
D:SHR-1702 and Camrelizumab Dose Expansion
Experimental
SHR-1702 and Camrelizumab given intravenously (IV).
干预措施: Camrelizumab (Drug)
结局指标
主要结局
Number of Participants with DLTs
时间窗: Approximately 28 Days
次要结局
- Immunogenicity as assessed by the presence of anti-drug antibodies(Approximately 2 years)
- Pharmacodynamic profile as assessed by receptor occupancy(Approximately 2 years)
- Safety and tolerability of SHR -1702 using Common Terminology Criteria for Adverse Events.(Dose Escalation Part -- Approximately 2 years)
- PK Parameter: Maximum Concentration (Cmax)(Approximately 2 years)
- PK Parameter: AUC, 0 to infinity(Approximately 2 years)
- PK Parameter: terminal half-life (t1/2)(Approximately 2 years)
- ORR: Percentage of Participants With a CR or PR(Approximately 2 years)
- PK Parameter: Clearance (CL)(Approximately 2 years)
- PK Parameter: Cmin at steady state (Cmin,ss)(Approximately 2 years)
- PK Parameter: Cmax at steady state (Cmax, ss)(Approximately 2 years)
研究者
研究点 (1)
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