NCT06993116进行中（未招募）1 期
A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4712 in Patients With Advanced Solid Tumors
Guangdong Hengrui Pharmaceutical Co., Ltd2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年6月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Dose Limited Toxicity (DLT)
研究概览
简要总结
This is a Phase 1, open label, first-in-human study to evaluate safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), immunogenicity and anti-tumor activity of SHR-4712 in patients with advanced solid tumors. Patients will treat with SHR-4712 until unacceptable toxicity or disease progression.
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
- •The subject voluntarily participates in this study and signs the informed consent form.
- •The subject is aged between 18 and 75 years old (inclusive), regardless of gender.
- •The subject must provide tumor tissue samples for biomarker testing.
- •The subject's ECOG performance status is 0 or
- •The expected survival time is ≥ 12 weeks.
- •The subject has at least one measurable lesion that meets the requirements of RECIST v1.
- •Laboratory test results confirm that the subject has sufficient functions of vital organs.
- •Female subjects of child-bearing potential must not be breastfeeding, have no possibility of pregnancy, and agree to comply with relevant contraceptive requirements.
排除标准
- •The subject has a history of or currently has meningeal metastases, or has symptomatic and active central nervous system metastases.
- •The subject has spinal cord compression that has not been radically treated by surgery and/or radiotherapy.
- •The subject has uncontrollable tumor-related pain as judged by the investigator.
- •The subject has clinically symptomatic moderate or severe ascites, uncontrollable pleural effusion or pericardial effusion of moderate amount or more.
- •The subject has received systemic immunosuppressive treatment within 14 days before the first study drug administration.
- •The subject has active autoimmune diseases or a history of autoimmune diseases with a possibility of recurrence.
- •The subject has severe cardiovascular and cerebrovascular diseases.
- •The subject has other uncontrolled concomitant diseases before the first drug administration.
- •The subject has a history of severe allergic reactions to the test drug and its main formulation components.
- •The subject has a history of immunodeficiency, including positive HIV serological test results, and other acquired or congenital immunodeficiency diseases.
- •The subject has had a severe infection within 4 weeks before the first drug administration.
- •The subject has a history of active pulmonary tuberculosis infection within 1 year before enrollment as found through medical history or CT examination, or has a history of active pulmonary tuberculosis infection more than 1 year ago but has not received regular treatment.
- •The subject has other serious physical or mental diseases, known alcohol or drug dependence, abnormal laboratory test results, and other factors that may increase the risk of participating in the study or interfere with the study results, and any other situations that the investigator deems unsuitable for participation in this study.
研究组 & 干预措施
SHR-4712 Group
Experimental
干预措施: SHR-4712 Injection (Drug)
结局指标
主要结局
Dose Limited Toxicity (DLT)
时间窗: First 21 days of treatment.
Adverse Events (AEs)
时间窗: Approximately 24 months.
次要结局
- Apparent volume of distribution (Vz/F)(Approximately 24 months.)
- Duration of objective tumor response (DoR)(Approximately 24 months.)
- Time to peak concentration (Tmax)(Approximately 24 months.)
- Peak concentration (Cmax)(Approximately 24 months.)
- Trough concentration (Ctrough)(Approximately 24 months.)
- Area under the concentration-time curve from time zero to the last measurable time point (AUC0-t)(Approximately 24 months.)
- Area under the concentration-time curve from time zero to infinity (AUC0-∞)(Approximately 24 months.)
- Elimination half-life (t1/2)(Approximately 24 months.)
- Apparent clearance (CL/F)(Approximately 24 months.)
- Objective response rate (ORR)(Approximately 24 months.)
- Disease control rate (DCR)(Approximately 24 months.)
- Progression-free survival (PFS)(Approximately 24 months.)
- Overall survival (OS)(Approximately 24 months.)
研究者
研究点 (2)
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