A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients
2022年6月26日 更新者:Suzhou Suncadia Biopharmaceuticals Co., Ltd.
A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SHR-2002 Injection or in Combination With Other Anti-cancer Therapy in Advanced Malignant Tumors of Patients
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-2002 injection monotherapy and in combination with other anti-cancer therapy for advanced malignant tumors of patients.
To explore the reasonable dosage of SHR-2002 injection monotherapy and dosage regimen of combination therapy for advanced malignant tumors of patients.
研究概览
地位
邀请报名
条件
研究类型
介入性
注册 (预期的)
240
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Henan
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Luoyang、Henan、中国、471003
- Henan Science and Technology University First Affiliated Hospital
-
-
Hunan
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Changsha、Hunan、中国、410006
- Hunan Cancer Hospital
-
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Shandong
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Linyi、Shandong、中国、276002
- LinYi Cancer Hospital
-
-
Shanghai
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Shanghai、Shanghai、中国、200433
- Shanghai Pulmonary Hospital
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Sichuan
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Chengdu、Sichuan、中国、410013
- West China Hospital of Sichuan University
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- Male or female aged ≥18 years and ≤70 years at the time of signing the ICF;
- Histopathologically or cytologically documented advanced or metastatic malignancies;
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- Life expectancy ≥12 weeks;
- Adequate organ functions as defined;
- Female and male patients of reproductive potential must agree to use highly effective contraception during the study treatment period and within 6 months after the last investigational drug administration; Female of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before the first dose of the investigational drugs and must not be breastfeeding.
Exclusion Criteria:
- Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
- Patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
- Patients with tumor-related pain that cannot be controlled as determined by the investigator;
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
- Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment;
- Surgical procedures requiring general anesthesia within 28 days prior to the first dose of the study treatment;
- Patients who have received >30 Gy of radical radiotherapy within 28 days before the first dose of study treatment;
- Unresolved CTCAE Grade >1 toxicity attributed to any prior anti-tumor therapy;
- Use of live attenuated vaccines within 28 days before the first dose of the study treatment;
- Patients who have received any systemic immunosuppressants within 14 days prior to the first dose of study treatment;
- Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy;
- History of autoimmune diseases;
- History of clinically significant bleeding symptom or bleeding tendency within 3 months before the first dose of study treatment;
- History of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment;
- Evidence or history of arterial/venous thrombosis within 3 months before the first dose;
- Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment;
- Known history of serious allergic reactions to the investigational product or its main ingredients;
- History of immunodeficiency;
- Presence of active hepatitis B or active hepatitis C;
- Severe infections within 4 weeks prior to the first study treatment;
- Evidence or history of active pulmonary tuberculosis within 1 year before study entry;
- any other conditions that are not suitable for participation in the study in the investigator's opinion.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:单组
|
Firstly Dose Escalation and Dose Expansion of SHR-2002 injection monotherapy should be conducted.
After RP2D and MTD of the SHR-2002 injection monotherapy were confirmed, Dose Escalation, Dose Expansion and Efficacy Expansion of SHR-2002 injection in combination with other anti-cancer treatment would be completed, including Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Maximum tolerated dose
大体时间:first dose of study medication up to 21 days
|
The Maximum tolerated dose of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection
|
first dose of study medication up to 21 days
|
Recommended phase II dose
大体时间:first dose of study medication up to 21 days
|
The Recommended phase II dose of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection
|
first dose of study medication up to 21 days
|
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
大体时间:from signature completion of ICF to 90 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks
|
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
|
from signature completion of ICF to 90 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Tmax
大体时间:0.5 hour before first dose to the 336 hours after first dose
|
PK parameters of single dose of SHR-2002 injection monotherapy
|
0.5 hour before first dose to the 336 hours after first dose
|
Cmax
大体时间:0.5 hour before first dose to the 336 hours after first dose
|
PK parameters of single dose of SHR-2002 injection monotherapy
|
0.5 hour before first dose to the 336 hours after first dose
|
AUC0-t
大体时间:0.5 hour before first dose to the 336 hours after first dose
|
PK parameters of single dose of SHR-2002 injection monotherapy
|
0.5 hour before first dose to the 336 hours after first dose
|
AUC0-∞
大体时间:0.5 hour before first dose to the 336 hours after first dose
|
PK parameters of single dose of SHR-2002 injection monotherapy
|
0.5 hour before first dose to the 336 hours after first dose
|
t1/2
大体时间:0.5 hour before first dose to the 336 hours after first dose
|
PK parameters of single dose of SHR-2002 injection monotherapy
|
0.5 hour before first dose to the 336 hours after first dose
|
CL
大体时间:0.5 hour before first dose to the 336 hours after first dose
|
PK parameters of single dose of SHR-2002 injection monotherapy
|
0.5 hour before first dose to the 336 hours after first dose
|
Vss
大体时间:0.5 hour before first dose to the 336 hours after first dose
|
PK parameters of single dose of SHR-2002 injection monotherapy
|
0.5 hour before first dose to the 336 hours after first dose
|
Cmax, ss
大体时间:0.5 hour before second dose to the 30 days after last dose
|
PK parameters of multiple doses of SHR-2002 monotherapy
|
0.5 hour before second dose to the 30 days after last dose
|
Ctrough, ss
大体时间:0.5 hour before second dose to the 30 days after last dose
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PK parameters of multiple doses of SHR-2002 monotherapy
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0.5 hour before second dose to the 30 days after last dose
|
Rac
大体时间:0.5 hour before second dose to the 30 days after last dose
|
PK parameters of multiple doses of SHR-2002 monotherapy
|
0.5 hour before second dose to the 30 days after last dose
|
RO
大体时间:0.5 hour before second dose to the 30 days after last dose
|
Receptor occupancy, PD indicators of SHR-2002 injection monotherapy
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0.5 hour before second dose to the 30 days after last dose
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Cytokine concentration
大体时间:0.5 hour before second dose to the 30 days after last dose
|
PD indicators of SHR-2002 injection monotherapy
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0.5 hour before second dose to the 30 days after last dose
|
Ctrough, ss
大体时间:0.5 hour before second dose to the 90 days after last dose
|
PK parameters of SHR -2002, Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection during combination therapy period
|
0.5 hour before second dose to the 90 days after last dose
|
Rac
大体时间:0.5 hour before second dose to the 90 days after last dose
|
PK parameters of SHR -2002, Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection during combination therapy period
|
0.5 hour before second dose to the 90 days after last dose
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ADA
大体时间:0.5 hour before second dose to the 90 days after last dose
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Anti-drug antibody, Immunogenicity of SHR-2002 in monotherapy and combination therapy, Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection
|
0.5 hour before second dose to the 90 days after last dose
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NAb
大体时间:0.5 hour before second dose to the 90 days after last dose
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Immunogenicity of Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection
|
0.5 hour before second dose to the 90 days after last dose
|
ORR
大体时间:from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months]
|
Objective Response Rate, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors
|
from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months]
|
DoR
大体时间:from the date of the firstly documented tumor response to the date of the firstly documented disease progression or the date of death for any reason, assessed up to 6 months
|
Duration of response, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors
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from the date of the firstly documented tumor response to the date of the firstly documented disease progression or the date of death for any reason, assessed up to 6 months
|
DCR
大体时间:from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, assessed up to 6 months
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Disease control rate, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors
|
from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, assessed up to 6 months
|
PFS
大体时间:from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, assessed up to 6 months
|
Progression-free survival, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors
|
from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, assessed up to 6 months
|
OS
大体时间:from the date of the first dose to the date of death for any reason,assessed up to 100 months
|
Overall survival, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors
|
from the date of the first dose to the date of death for any reason,assessed up to 100 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年2月22日
初级完成 (预期的)
2023年1月31日
研究完成 (预期的)
2023年6月30日
研究注册日期
首次提交
2022年1月3日
首先提交符合 QC 标准的
2022年1月17日
首次发布 (实际的)
2022年1月20日
研究记录更新
最后更新发布 (实际的)
2022年6月28日
上次提交的符合 QC 标准的更新
2022年6月26日
最后验证
2022年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- SHR-2002-I-101
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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