NCT05154604尚未招募1 期
A Phase 1 Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1921 in Subjects With Advanced Malignant Solid Tumour .
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 156
- 主要终点
- Dose Limited Toxicity (DLT)
研究概览
简要总结
To assess the safety and tolerability of SHR-A1921 in patients with advanced solid tumours, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended phase II dose (RP2D) of SHR-A1921
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
- •Voluntary participation and written informed consent；
- •Aged 18-75 years (inclusive), males and females;
- •Consents to provide tumor tissue samples;
- •Subjects must have histologically or clinically confirmed advanced and/or metastatic malignancies for which failure of standard treatment or lack of effective standard treatment;
- •At least one measurable lesion according to RECIST v1.1;
- •ECOG score of 0-1;
- •Expected survival ≥ 12 weeks;
- •Adequate bone marrow reserve and organ function ；
- •For female patients of childbearing potential or male patients with partners of childbearing potential who are not sterilized by surgical operations, they are required to use a medically approved contraceptive measure during the study treatment period and within 3 months after the end of the study treatment; For female patients of childbearing potential who are not sterilized by surgical operations, they must have a negative serum HCG test result within 72 h prior to study enrollment; and they must not be in the lactation period;
排除标准
- •Known and untreated central nervous system (CNS) or leptomeningeal metastases;
- •Macrovascular invasion based on imaging;
- •Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
- •Has a history of a second malignancy;
- •History of immunodeficiency disease or organ transplant;
- •Uncontrolled cardiac diseases or symptoms;
- •Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
- •Has a history of active chronic enteritis 6 weeks prior to the initiation of the study treatment or intestinal obstruction, gastrointestinal perforation 3 months prior to the initiation of the study treatment;
- •Has a history of Grade≥2 bleeding 4 weeks prior to the initiation of the study treatment or is current receiving anticoagulation therapy;
- •Subjects with active hepatitis B or active hepatitis C;
- •Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.
- •Has unresolved toxicities from previous anticancer therapy.
- •Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921;
- •Subjects with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.
研究组 & 干预措施
Treatment group: SHR-A1921
Experimental
干预措施: SHR-A1921 (Drug)
结局指标
主要结局
Dose Limited Toxicity (DLT)
时间窗: 21 Days (first cycle)
Maximum Tolerable Dose (MTD)
时间窗: 21 Days (first cycle)
Recommended phase II dose (RP2D)
时间窗: Screening up to dose escalation and expansion study completion, appropriately to 1 year
Adverse Events
时间窗: Screening up to study completion, an average of 1 year
Incidence and grade of adverse events as assessed by CTCAE v5.0
次要结局
- Terminal half-life (t1/2) of SHR-A1921、total antibody(Screening up to end of treatment, an average of 1 year)
- Objective Response Rate (ORR) assessed by site investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)
- Maximum concentration (Cmax) of SHR-A1921、total antibody(Screening up to end of treatment, an average of 1 year)
- Time to reach maximum concentration (Tmax) of SHR-A1921、total antibody(Screening up to end of treatment, an average of 1 year)
- Area under the concentration-time curve from time zero to the time of the last quantifiable time point t (AUC0-t) of SHR-A1921、total antibody(Screening up to end of treatment, an average of 1 year)
- Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-t) of SHR-A1921、total antibody(Screening up to end of treatment, an average of 1 year)
- Anti-drug antibody(ADA) level of SHR-A1921(Screening up to 90 days after the last dose, an average of 1 year)
- Duration of Response (DoR) assessed by site investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)
- Total body clearance (CL) of SHR-A1921、total antibody(Screening up to end of treatment, an average of 1 year)
- Volume of distribution at steady state (Vss) of SHR-A1921、total antibody(Screening up to end of treatment, an average of 1 year)
- Mean residence time (MRT) of SHR-A1921、total antibody(Screening up to end of treatment, an average of 1 year)
- Maximum steady-state drug concentration during a dosage interval (Css, max) of SHR-A1921、total antibody(Screening up to end of treatment, an average of 1 year)
- Minimum steady-state drug concentration during a dosage interval (Css, min) of SHR-A1921、total antibody(Screening up to end of treatment, an average of 1 year)
- Accumulation ratio (Rac) of SHR-A1921、total antibody(Screening up to end of treatment, an average of 1 year)
- Disease Control Rate (DCR) assessed by site investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)
- Progression-Free Survival (PFS) assessed by site investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)
- Overall Survival (OS)(Screening up to study completion, an average of 1 year)
研究者
相似试验
进行中（未招募）
1 期
A Study of SHR-A1904 in Patients With Advanced Solid CancerAdvanced Solid CancerNCT04877717Shanghai Hengrui Pharmaceutical Co., Ltd.107
尚未招募
1 期
Phase I Study of SHR-2022 Injection in the Treatment of Patients With Advanced Malignant TumorsAdvanced Malignant CancerNCT06131216Suzhou Suncadia Biopharmaceuticals Co., Ltd.116
招募中
1 期
GH21 Capsules for Advanced Solid Tumors: A Study on Safety and Early ResultsAdvanced Solid TumorHead and Neck NeoplasmColorectal CancerPancreatic CancerNon-Small Cell Lung CancerNCT05183243Suzhou Genhouse Bio Co., Ltd.68
尚未招募
1 期
A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.HER2 Low Advanced or Metastatic Breast CancerNCT05792410Jiangsu HengRui Medicine Co., Ltd.300
终止
1 期
A Study of HRS2543 in Patients With Advanced TumorsAdvanced TumorsNCT05068856Shanghai Hengrui Pharmaceutical Co., Ltd.10