NCT03710265Unknown1 期
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 and Expansion to Selected Indications
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) assessed by site investigator as per RECIST 1.1
研究概览
简要总结
The main purpose of this Phase I study is to access the safety and tolerability of SHR-1701 at different dose levels. It is hoped to find out the recommended dose for Phase II/III.
详细描述
This is a Phase I, open-label trial in patients with metastatic or locally advanced solid tumor. There are three parts of the study: a dose-escalation part, a dose-expansion part, and a clinical expansion part. Dose escalation part is a standard "3+3" cohort design, for which 3 or 6 subjects will be enrolled at each dose level depending on the occurrence of dose-limiting toxicities (DLTs). Dose-expansion means that at least 10 subjects (included subjects of the dose-escalation part) will be selected in 2 - 3 dose levels to focus on the pharmacokinetics (PK) / pharmacodynamic (PD) features. After determination of the recommended dose for Phase II (RP2D), clinical expansion will be opened. Many more subjects will be invited to take part in the study and received the study drug at the RP2D. Additional purpose of the study is to find out whether the study drug has anti-tumor effects.
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
- •Male or female subjects aged between 18 and 75 years
- •Life expectancy >= 12 weeks as judged by the Investigator
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Has measurable disease per RECIST 1.1
- •Subjects with confirmed metastatic or locally advanced solid tumor (histologically or cytologically) and there is no known effective anti-tumor treatment (refractory or relapsed from standard treatment).
- •Adequate hematological, hepatic and renal function as defined in the protocol
- •Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs.
- •Able to understand and sign an informed consent, and able to comply with all procedures
排除标准
- •Anticancer treatment within 28 days before the first dose of study drug
- •Major surgery within 28 days before start of trial treatment (prior diagnostic biopsy is permitted)
- •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, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded
- •Subjects with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are excluded
- •Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention.
- •History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy, e.g., hepatitis B or C
- •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
研究组 & 干预措施
SHR-1701
Experimental
干预措施: SHR-1701 (Drug)
结局指标
主要结局
Objective Response Rate (ORR) assessed by site investigator as per RECIST 1.1
时间窗: Screening up to study completion, an average of 1 year
Safety and tolerability profile of SHR-1701
时间窗: Up to week 3
Number of Subjects who occurs dose-limiting toxicity (DLTs)
次要结局
- Area under the plasma concentration versus time curve (AUC) of SHR-1701(Up to 4 weeks after last treatment)
- Half-time (t1/2) of SHR-1701(Up to 4 weeks after last treatment)
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors(12 months (anticipated))
- Immunogenicity of SHR-1701(12 months (anticipated))
- Pharmacodynamic features of SHR-1701(12 months (anticipated))
- Clinical Benefit Rate(CBR) per RECIST 1.1(12 months (anticipated))
- Peak Plasma Concentration (Cmax) of SHR-1701(Up to 4 weeks after last treatment)
- Best Overall Response (BOR) per RECIST 1.1(12 months (anticipated))
- Trough plasma concentration (C trough) of SHR-1701(Up to 4 weeks after last treatment)
- Duration of Response (DoR) per RECIST 1.1(12 months (anticipated))
- Overall Survival (OS)(12 months (anticipated))
- Disease Control Rate (DCR) per RECIST 1.1(12 months (anticipated))
- Progression-Free Survival (PFS) per RECIST 1.1(12 months (anticipated))
研究者
研究点 (1)
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