中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2300070786
最近更新日期： Date of Last Refreshed on：	2023-08-20 23:51:56
注册时间： Date of Registration：	2023-04-23 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	AYK103注射液在晚期实体瘤中的有效性、安全性及耐受性的IIT研究
Public title：	IIT Study on the Safety and Tolerance of AYK103 Injection in Advanced Solid Tumor
注册题目简写：
English Acronym：
研究课题的正式科学名称：	AYK103注射液在晚期实体瘤中的有效性、安全性及耐受性的IIT研究
Scientific title：	IIT Study on the Safety and Tolerance of AYK103 Injection in Advanced Solid Tumor
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	杨光	研究负责人：	胡海燕
Applicant：	Guang Yang	Study leader：	Haiyan Hu
申请注册联系人电话： Applicant telephone：	+86 139 4487 0709	研究负责人电话： Study leader's telephone：	+86 189 3017 4575
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	guang.yang@maxvax.cn	研究负责人电子邮件： Study leader's E-mail：	xuri1104@163.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	上海浦东新区巴圣路160号	研究负责人通讯地址：	上海市徐汇区宜山路600号
Applicant address：	160 Basheng Road, Pudong District, Shanghai	Study leader's address：	600 Yishan Road, Xuhui District, Shanghai
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	上海安奕康生物科技有限公司
Applicant's institution：	Shanghai Ayk Biotechnology Co., Ltd
研究负责人所在单位：	上海市第六人民医院
Affiliation of the Leader：	Shanghai Sixth People‘s Hospital

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2023-040	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	上海市第六人民医院伦理委员会
Name of the ethic committee：	Ethics Committee of Shanghai Sixth People's Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2023-04-04 00:00:00
伦理委员会联系人：	庞路阳
Contact Name of the ethic committee：	Luyang Pang
伦理委员会联系地址：	上海市徐汇区宜山路600号
Contact Address of the ethic committee：	600 Yishan Road, Xuhui District, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 64369181	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

上海市第六人民医院

Primary sponsor：

Shanghai Sixth People‘s Hospital

研究实施负责（组长）单位地址：

上海市徐汇区宜山路600号

Primary sponsor's address：

600 Yishan Road, Xuhui District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市第六人民医院	具体地址：	上海市徐汇区宜山路600号
Institution hospital：	Shanghai Sixth People‘s Hospital	Address：	600 Yishan Road, Xuhui District, Shanghai

经费或物资来源：

资助方上海安奕康生物科技有限公司提供

Source(s) of funding：

The funding is provided by Shanghai Ayk Biotechnology Co., Ltd

研究疾病：

肿瘤

Target disease：

Cancer

研究疾病代码：

Target disease code：

研究类型：

治疗研究

Study type：

Treatment study

研究所处阶段：

探索性研究/预试验

Study phase：

0

研究设计：

单臂

Study design：

Single arm

研究目的：

AYK103注射液在晚期实体瘤中的有效性、安全性及耐受性

Objectives of Study：

The Safety and Tolerance of AYK103 Injection in Advanced Solid Tumor

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Fully understand the purpose, nature, method, and potential adverse reactions of the experiment, voluntarily participate as a participant, and sign an informed consent form before starting any procedure;
2.Male or female patients aged 18 to 75 years (including boundary values);
3. Patients with advanced malignant solid tumors who have been diagnosed by histology or cytology and currently have no standard treatment plan or are ineffective in standard treatment (disease progression or treatment intolerance after treatment), including but not limited to: bone and soft tissue sarcomas, etc;
4.According to the RECIST v1.1 standard, there should be at least one measurable lesion (CT scan or MRI no more than 4 weeks prior to signing the ICF);
5. Having injectable lesions (which can be directly injected or assisted by medical imaging instruments);
6. The Eastern Cooperative Organization for Oncology (ECOG) has a physical fitness score of 0 or 1;
7. Expected survival time>=3 months;
Within 7 days before the first administration, patients must meet the following organ functions and bone marrow reserves:
a. Hematology: Platelets (PLT)>=80 × 109/L, neutrophil count (ANC)>=1.5 × 109/L, hemoglobin>=9 g/dL (no auxiliary means such as EPO, G-CSF, or GM-CSF have been received within 14 days before the first administration, and no blood transfusion has been received for at least 7 days);
b. Coagulation function: INR<=1.5, APTT<=1.5 × ULN (upper limit of normal value), PT<=1.5 × ULN;
c. Liver function: Total bilirubin<=1.5 × ULN (total bilirubin in Gilbert syndrome patients<=3) × ULN can be grouped), AST and ALT<=3 × ULN (if there is liver metastasis, AST, ALT<=5 × ULN);
d. Renal function: serum creatinine<=1.5 × ULN or creatinine clearance rate>=50mL/min (according to Cockcroft Fault formula)
e. Cardiac function: female QTcF<=470 ms, male<=450 ms.
9. Able to communicate well with researchers and understand and comply with the requirements of this study.

排除标准：

1.妊娠检查阳性或处于哺乳期的育龄女性； 2.对类似产品或辅料过敏或超敏的患者； 3.首次给药前28天内使用其他研究药物或参与其他药物临床试验者； 4.首次给药前停止抗肿瘤治疗28天，包括放射治疗（姑息放疗除外）、化疗、生物治疗、内分泌治疗和免疫治疗，小分子靶向药可按5个半衰期停药计算，使用中草药抗肿瘤作用超过 14 天，接受联合用药的受试者按较长半衰期药物的 5 倍半衰期结束后可以入组； 5.首次给药前 28 天内接受过手术或介入治疗（不包括肿瘤活检、穿刺、port、PICC等），骨折或者靶病灶存在未愈合的伤口、溃疡； 6.首次给药前 28 天内接受过全身性皮质激素或其他免疫抑制药物者或正在使用抗病毒药物者； 7.伴有活动性脑转移、脊髓压迫、癌性脑膜炎等临床症状，或其他证据表明患者脑和脊髓转移未得到控制，经研究者判断不适合入组者； 8.临床上明显和/或迅速积聚的腹水，心包和/或胸腔积液者； 9.有严重的心脑血管疾病史，包括但不限于： a.有严重的心脏节律或传导异常，如需要临床干预的室性心律失常、II-III 度房室传导阻滞等； b.按美国纽约心脏病协会（NYHA）标准，III~IV 级心功能不全者； c.首次给药前 6 个月内发生急性冠脉综合征、充血性心力衰竭、主动脉夹层、脑卒中或其他 3 级及以上心脑血管事件； d.临床无法控制的高血压（经标准抗高血压治疗后血压仍无法控制在收缩压< 140 mmHg 和舒张压 < 90 mmHg）。 10.既往抗肿瘤治疗的不良反应尚未恢复到 CTCAE v5.0 等级评价<= 1级（脱发等研究者判断无安全风险的毒性除外）； 11.无法控制或有严重疾病的患者，包括但不限于持续或活动性感染需要抗生素治疗； 12.既往免疫缺陷病史，包括患有其他获得性、先天性免疫缺陷疾病，或有器官移植史，或有异基因骨髓移植史，或自体造血干细胞移植； 13.需要系统性治疗的剥脱性皮肤病史者（如湿疹或异位性皮肤炎等）； 14.人类免疫缺陷病毒（HIV）抗体阳性者； 15.存在活动性乙肝（HBV）/丙肝（HCV）感染者[既往有丙肝病史但筛选期 HCV RNA 阴性可入组；HBsAg 阳性但 HBV DNA<500 IU/ml或HBV DNA低于研究中心检测下限者可入组（原发性肝癌受试者HBV DNA<1000 IU/ml可入组）]； 16.在整个研究期及安全随访期内不愿意使用适当避孕方法的男性和女性患者（如同时使用杀精剂、屏障性避孕药和/或宫内避孕药等，详见附录 1）； 17.患有已知的可能影响试验依从性的精神疾病或障碍的患者； 18.患有可能需要除研究药物AYK103 以外的其他抗肿瘤治疗的恶性肿瘤患者； 19.脾脏切除者；（与免疫相关）； 20.研究者认为如果发生治疗后肿瘤肿胀，可能导致显著临床不良反应的，包括但不限于肿瘤包围颈动脉等主要血管结构、肿瘤与重要神经血管结构、气道相邻或肿瘤位于具有不良事件高风险或不适合瘤内注射位置。 21.研究者判断不适于参与研究的患者。

Exclusion criteria：

1. Pregnant (positive pregnancy test before medication) or breastfeeding women; 2. A history of severe allergy to excipients of the investigational drug; 3. Received any investigational drug within 28 days prior to initial dosing; 4. Have anti-tumor therapy within 28 days before the first dose, including radiotherapy (except palliative radiotherapy), chemotherapy, biological therapy, endocrine therapy and immunotherapy, small molecule targeted drugs can be counted as 5 half-life discontinuations, the antitumor effect of Chinese herbal medicines for more than 14 days, subjects receiving the combination drug can be enrolled after the end of the 5-fold half-life of the longer half-life drug; 5. Have undergone surgery or interventional therapy (excluding tumor biopsy, puncture, etc.) within 28 days prior to initial administration, or wounds, ulcers, fractures that have not healed; 6. Patients who are received systemic corticosteroids or other immunosuppressive drugs within 28 days prior to initial administration or on antivirals; 7. Subjects with clinical symptoms of brain metastasis, spinal cord compression, cancerous meningitis, or other evidence of uncontrolled brain or spinal cord metastasis. 8. Clinically evident and/or rapidly accumulating ascites, pericardial and/or pleural effusion; 9. Severe cardiovascular disease, including but not limited to: a. Have severe heart rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc.; b. According to the standards of the New York Heart Association (NYHA), grade III~IV cardiac insufficiency; c. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or greater cardiovascular and cerebrovascular events within 6 months prior to first dose; d. Clinically uncontrolled hypertension (BP < systolic blood pressure 140 mmHg and diastolic blood pressure < 90 mmHg despite standard antihypertensive therapy) 10. The adverse reactions of previous anti-tumor treatment could not be recovered to NCI CTCAE v5.0 level ≤1 (except for toxicity without safety risk as determined by researchers, such as hair loss). 11. Patients who are uncontrollable or have severe illness, including but not limited to persistent or active infections, who require antibiotic therapy; 12. Previous history of immunodeficiency, including other acquired or congenital immunodeficiency disorders, or a history of organ transplantation, or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation; 13. History of exfoliative skin requiring systemic treatment (e.g., eczema or atopic dermatitis) 14. Human immunodeficiency virus (HIV) antibody positive patients; 15. Patients with active hepatitis B (HBV)/hepatitis C (HCV) infection [prior history of hepatitis C but negative HCV RNA during screening; HBsAg positive but HBV DNA < 500 IU/ml or HBV DNA below the lower limit of the center test can be enrolled (primary liver cancer subjects with HBV DNA <1000 IU/ml can be enrolled)]; 16. Men and women who were reluctant to use appropriate methods of contraception throughout during the study period (simultaneous use of spermicides, barrier contraceptives, and/or intrauterine contraceptives, etc.); 17. Patients with psychiatric disorders or disorders that may affect trial adherence; 18. Patients who may require antineoplastic therapy other than the investigational AYK103 injection 19. Screening patients who have undergone surgery;(Immune-related) 20. The investigators believe that if tumor swelling occurs after treatment, it may lead to significant clinical adverse effects, including but not limited to the tumor surrounding major vascular structures such as the carotid artery, the tumor adjacent to important neurovascular structures, the airway, or the tumor is located in a location with a high risk of adverse events or is not suitable for intratumoral injection; 21. Other circumstances in which the researcher thinks that the patient should not participate in this experimental study.

研究实施时间：

Study execute time：

从 From 2023-04-01 00:00:00至 To 2024-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-05-01 00:00:00 至 To 2023-08-01 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	9
Group：	Experimental group	Sample size：	9
干预措施：	AYK103注射液	干预措施代码：
Intervention：	AYK103 injection	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市第六人民医院	单位级别：	三甲
Institution hospital：	Shanghai Sixth People‘s Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	最大耐受剂量	指标类型：	主要指标
Outcome：	Maximum tolerated dose	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	剂量限制性毒性	指标类型：	主要指标
Outcome：	Dose-limiting toxicity	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	客观缓解率	指标类型：	主要指标
Outcome：	Objective Response Rate	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	细胞因子	指标类型：	次要指标
Outcome：	cytokines	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	免疫细胞	指标类型：	次要指标
Outcome：	Immune cells	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：
Sample Name：	Blood	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

标本中文名：	肿瘤组织	组织：
Sample Name：	Tumor tissue	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	75	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：
Blinding：

是否共享原始数据： IPD sharing	否No
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	http://www.chictr.org.cn
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	http://www.chictr.org.cn
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	eCRF、EDC
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	eCRF、EDC
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2023-04-23 16:07:25