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：	ChiCTR2500114935
最近更新日期： Date of Last Refreshed on：	2025-12-19 09:30:35
注册时间： Date of Registration：	2025-12-19 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	注射用YKYY031在晚期实体瘤患者中的I期临床试验
Public title：	Phase I clinical trial of YKYY031 for injection in patients with advanced solid tumors
注册题目简写：
English Acronym：
研究课题的正式科学名称：	评估注射用YKYY031在晚期实体瘤患者中的安全性、耐受性、药代动力学和初步抗肿瘤活性的I期临床试验
Scientific title：	Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of YKYY031 for injection in patients with advanced solid tumors
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：	周玉婷	研究负责人：	沈琳
Applicant：	Yuting Zhou	Study leader：	Lin Shen
申请注册联系人电话： Applicant telephone：	+86 186 0641 7018	研究负责人电话： Study leader's telephone：	+86 10 8819 6561
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：	zhouyuting@bjykkc.com	研究负责人电子邮件： Study leader's E-mail：	doctorshenlin@sina.con
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：	北京市北京经济技术开发区科创七街 11 号院 3 号楼	研究负责人通讯地址：	北京海淀区阜成路52号
Applicant address：	Building 3, Yard 11, Kechuang 7th Street, Beijing Economic-Technological Development Area, Beijing	Study leader's address：	No. 52, Fucheng Road, Haidian District, Beijing
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：	北京悦康科创医药科技股份有限公司
Applicant's institution：	Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.
研究负责人所在单位：	北京肿瘤医院
Affiliation of the Leader：	Beijing Cancer 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：	2025YW268	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：	北京肿瘤医院医学伦理委员会
Name of the ethic committee：	Beijing cancer hospital medical ethics committee
伦理委员会批准日期： Date of approved by ethic committee：	2025-11-17 00:00:00
伦理委员会联系人：	廖红舞
Contact Name of the ethic committee：	Hongwu Liao
伦理委员会联系地址：	北京市海淀区阜成路81号
Contact Address of the ethic committee：	No. 81, Fucheng Road, Haidian District, Beijing
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 10 8819 6391	伦理委员会联系人邮箱： Contact email of the ethic committee：	liaohongwu2015@163.com

研究实施负责（组长）单位：

北京肿瘤医院

Primary sponsor：

Beijing Cancer Hospital

研究实施负责（组长）单位地址：

北京海淀区阜成路52号

Primary sponsor's address：

No. 52, Fucheng Road, Haidian District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	北京	市(区县)：	北京
Country：	China	Province：	Beijing	City：	Beijing
单位(医院)：	北京悦康科创医药科技股份有限公司	具体地址：	北京市北京经济技术开发区科创七街 11 号院 3 号楼
Institution hospital：	Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.	Address：	Building 3, Yard 11, Kechuang 7th Street, Beijing Economic-Technological Development Area, Beijing

国家：	中国	省(直辖市)：	北京	市(区县)：	北京
Country：	China	Province：	Beijing	City：	Beijing
单位(医院)：	杭州天龙药业有限公司	具体地址：	浙江省杭州市钱塘区下沙街道银海科创中心3幢701室
Institution hospital：	Hangzhou Tianlong Pharmaceutical Co., Ltd.	Address：	Room 701, Building 3, Yinhai Science and Technology Innovation Center, Xiasha Subdistrict, Qiantang District, Hangzhou, Zhejiang, 310020, China

经费或物资来源：

北京悦康科创医药科技股份有限公司、杭州天龙药业有限公司

Source(s) of funding：

Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. Hangzhou Tianlong Pharmaceutical Co., Ltd.

研究疾病：

晚期实体瘤患者

Target disease：

Patients with advanced solid tumors

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

I期临床试验

Study phase：

1

研究设计：

单臂

Study design：

Single arm

研究目的：

主要目的：评估注射用YKYY031在晚期实体瘤患者中的安全性和耐受性，并观察注射用YKYY031的剂量限制性毒性、确定最大耐受剂量（如有）及推荐的II期临床剂量。次要目的：评估注射用YKYY031在晚期实体瘤患者中的药代动力学特征。评估注射用YKYY031在晚期实体瘤患者中的初步抗肿瘤活性。评估注射用YKYY031在晚期实体瘤患者中的免疫原性。评估注射用YKYY031在晚期实体瘤患者中的免疫相关特征。探索性目的：探索生物标志物与注射用YKYY031抗肿瘤活性的相关性。

Objectives of Study：

Primary objective: To evaluate the safety and tolerability of YKYY031 for injection in patients with advanced solid tumors, to observe the dose-limiting toxicity of YKYY031 for injection, to determine the maximum tolerated dose (if any) and the recommended phase II clinical dose. Secondary objective: To evaluate the pharmacokinetic profile of YKYY031 for injection in patients with advanced solid tumors. To evaluate the preliminary antitumor activity of injectable YKYY031 for injection in patients with advanced solid tumors. To evaluate the immunogenicity of YKYY031 for injection in patients with advanced solid tumors. To evaluate the immune-related profile of YKYY031 for injection in patients with advanced solid tumors. Exploratory Objective: To explore the correlation between biomarkers and the antitumor activity of YKYY031 for injection.

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. Male or female patients aged 18 years <= age <= 75 at the time of signing the informed consent form;
2. Histologically or cytologically confirmed advanced or metastatic solid tumor that has failed standard therapy, or is intolerant or refuses to receive standard therapy. Patients with colorectal cancer need to have previously received at least second-line standard therapy failure, or are intolerant or refuse to receive standard therapy (progression during adjuvant/neoadjuvant chemotherapy or within 6 months of the last treatment can be regarded as first-line treatment failure); Patients with pancreatic cancer who have previously failed first-line standard therapy, or are intolerant or refuse to receive standard treatment;
3. Participants in the dose expansion phase need to have HLA-A*11:01 as HLA subtype;
4. ECOG physical status score: 0~1 points;
5. Expected survival >=3 months;
6. At least one measurable lesion (longest diameter of non-lymph nodes >=10 mm, shortest diameter of lymph nodes >=15 mm) according to RECIST V1.1 criteria
7. Good function of major organs, that is, relevant examination indicators meet the following requirements:
Hemoglobin >=90 g/L, neutrophil count >=1.5×10^9/L, platelet count >=80×10^9/L within 14 days before the first dose of vaccination;
Total bilirubin <= 1.5× ULN; In case of liver metastases or Gilbert syndrome, total bilirubin <=3× ULN;
ALT or AST<=3×ULN; ALT or AST <=5× ULN if liver metastases are present;
Serum creatinine <=1.5×ULN or creatinine clearance >=50 ml/min (Cockcroft-Gault formula);
Prothrombin time <= 1.5× ULN (unless anticoagulation with warfarin is being used);
INR <= 1.5× ULN (unless warfarin anticoagulation is being used);
Cardiac Doppler ultrasound assessment: LVEF >=50%
8. Female or male participants of childbearing potential have no childbearing, egg donation, or sperm donation plan from the date of signing the informed consent form to 6 months after the last treatment of the study, and must agree to use effective contraception (including one or more non-drug contraceptive measures) or safety measures during this period;
9. Agree to abide by the requirements and procedures of the clinical trial and voluntarily sign the informed consent form.

排除标准：

1.对试验药物（包括任何辅料）过敏。既往有任何药物、食物、接种疫苗的严重过敏史，如过敏性休克、过敏性喉头水肿、过敏性呼吸困难、过敏性紫癜、血小板减少性紫癜、局部过敏坏死反应（Arthus反应）等； 2.患者既往有其它肿瘤病史，但已治愈的且筛选前5年内未复发的皮肤基底细胞癌、皮肤鳞状细胞癌、浅表性膀胱癌、原位宫颈癌等研究者认为可以入组的恶性肿瘤史除外； 3.具有临床症状的中枢神经系统转移或脑膜转移，或有其他证据表明参与者中枢神经系统转移或脑膜转移灶尚未控制，经研究者判断不适合入组者。病情稳定（影像学检查4周内没有发生进展）、本研究首次用药开始前至少4周不需要使用类固醇药物治疗的脑转移患者可以入组； 4.有显著临床意义的心血管疾病，包括但不局限于；a）充血性心衰（NYHA 分级> II级）；b）过去6个月内发生过心肌梗塞、不稳定性心绞痛、严重的心包疾病、严重的心肌疾病；c）存在需要治疗的心脏瓣膜反流或狭窄；d）任何需要治疗或者干预的室上性心律失常或室性心律失常；存在药物控制不佳的恶性心律失常；完全性左束支传导阻滞，II度或III度房室传导阻滞；e）QT间期（QTcF）男性>450 ms，女性>470 ms；f）控制不佳的高血压（定义为在2种或3种降压药物控制情况下，测量收缩压≥160 mmHg或舒张压≥100 mmHg）； 5.任何活动性自身免疫病或有自身免疫病病史，包括但不限于与免疫有关的神经疾病、多发性硬化症、自身免疫性（脱髓鞘）神经病、格林巴利综合征、重症肌无力、系统性红斑狼疮、结缔组织疾病、硬皮病、自身免疫性肝炎、中毒性表皮坏死松解症或Stevens-Johnson综合征（使用稳定剂量胰岛素的I型糖尿病、接受稳定激素替代治疗的甲状腺功能减退症等除外）； 6.有任何不可控的临床疾病（例如，呼吸系统、循环系统、神经系统、血液系统、泌尿生殖系统、内分泌系统疾病）或精神疾病（例如，抑郁，精神分裂症）或其他重大疾病等经研究者评估认为会妨碍提供知情同意、干扰试验结果的解读、参加本试验可能给参与者带来风险、或以其他方式影响实现试验目的，包括由研究者判断的伴有无法控制的胸腔积液、心包积液，或腹腔积液； 7.已知间质性肺炎病史或高度怀疑有间质性肺炎的患者；或存在肺部异常，可能会对试验期间可疑的药物相关肺毒性的检测或处理造成干扰的患者； 8.接种部位有任何异常且研究者认为会妨碍观察接种部位局部反应的患者； 9.存在肌肉注射禁忌症； 10.在首次给药前4周或5个半衰期内（以时间短者为准）接受过任何抗肿瘤治疗（包括化疗、靶向治疗、免疫治疗等）或参加过其他药物或器械临床试验；在首次给药前2周接受过具有明确抗肿瘤适应症的中药或中成药； 11.既往抗肿瘤治疗相关不良反应尚未恢复至CTCAE≤1级的患者，研究者判断无安全风险的毒性除外，如脱发、2级外周神经毒性、经激素替代治疗稳定的甲状腺功能减退等； 12.既往接受过器官移植或异基因造血干细胞移植； 13.首剂疫苗接种前14天内，使用皮质类固醇（>10 mg/天的泼尼松或等价剂量的其他糖皮质激素）或其他免疫抑制剂进行系统治疗的参与者。在没有活动性自身免疫疾病的情况下，允许吸入或局部使用类固醇和剂量≤10 mg/天泼尼松疗效剂量的肾上腺激素替代； 14.首剂疫苗接种前4周内接种过活疫苗/减毒活疫苗/灭活疫苗； 15.既往接受过同靶点类似的治疗性肿瘤疫苗； 16.患有出血性疾病（如凝血因子缺乏、凝血功能障碍[经研究者判断不适合入组]），或注射、抽血后有明显瘀伤或出血史； 17.筛选前3个月内献血或大量失血（>450 ml），或计划在研究期间献血或血液成分； 18.筛选前4周内接受过大手术（导管置入、方案要求进行的活检手术等小手术不作为排除标准），或入组前手术或创伤的影响消除不足14天； 19.有药物滥用史或已知的医疗、心理或社会状况，如酗酒或吸毒史； 20.人类免疫缺陷病毒抗体检查结果呈阳性，患有活动性梅毒（定义为梅毒抗体检测阳性且反应素试验阳性），或活动性乙型肝炎（定义为HBV DNA≥2000 IU/ml）或丙型肝炎（定义为HCV RNA检测阳性）； 21.患者有活动性TB（怀疑有活动性TB的患者，需进一步就诊感染科以明确诊断）或活动性TB病史；或需要全身治疗的严重急性或慢性感染； 22.妊娠期或哺乳期女性 23.研究者认为不适合参加本试验的其他情况。

Exclusion criteria：

1. Allergic to the trial drug (including any excipients). Have a history of severe allergies to any medicine, food, or vaccination, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.; 2. The patient has a history of other tumors, except for malignant tumors that have been cured and have not recurred within 5 years before screening, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ and other malignant tumors that the researcher believes can be included; 3. Those with clinical symptoms of central nervous system metastasis or meningeal metastasis, or other evidence that the participant's central nervous system metastasis or meningeal metastasis has not been controlled, and who are judged by the researcher to be unsuitable for enrollment. Patients with brain metastases whose disease is stable (no progression within 4 weeks of imaging examination) and who do not require steroid treatment for at least 4 weeks before the first dose of this study can be enrolled; 4. Cardiovascular diseases with significant clinical significance, including but not limited to; a) congestive heart failure (NYHA classification > Level II); b) Myocardial infarction, unstable angina, severe pericardial disease, severe myocardial disease in the past 6 months; c) The presence of cardiac valve regurgitation or stenosis that requires treatment; d) Any supraventricular arrhythmia or ventricular arrhythmia that requires treatment or intervention; the presence of malignant arrhythmias that are poorly controlled by medications; complete left bundle branch block, II or III degree atrioventricular block; e) QT interval (QTcF) in men >450 ms, women >470 ms; f) poorly controlled hypertension (defined as systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg when controlled by 2 or 3 antihypertensive drugs); 5. Any active autoimmune disease or a history of autoimmune disease, including but not limited to immune-related neurological diseases, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus, connective tissue diseases, scleroderma, autoimmune hepatitis, toxic epidermal necrolysis or Stevens-Johnson syndrome (except for type I diabetes using stable doses of insulin, hypothyroidism receiving stable hormone replacement therapy, etc.); 6. Have any uncontrollable clinical diseases (for example, diseases of the respiratory system, circulatory system, nervous system, blood system, genitourinary system, endocrine system) or mental diseases (for example, depression, schizophrenia) or other major diseases that the researcher assesses will hinder the provision of informed consent, interfere with the interpretation of trial results, participate in this trial may bring risks to participants, or otherwise affect the realization of the purpose of the trial, including uncontrollable pleural effusion, pericardial effusion, or ascites effusion as judged by the researcher; 7. Patients with a known history of interstitial pneumonia or who are highly suspected of having interstitial pneumonia; or patients with pulmonary abnormalities that may interfere with the detection or processing of suspected drug-related pulmonary toxicity during the trial; 8. Patients with any abnormalities at the vaccination site that the researcher believes will hinder the observation of local reactions at the vaccination site; 9. There are contraindications for intramuscular injection; 10. Have received any anti-tumor treatment (including chemotherapy, targeted therapy, immunotherapy, etc.) or participated in clinical trials of other drugs or devices within 4 weeks or 5 half-lives (whichever is shorter) before the first dose; have received traditional Chinese medicine or Chinese patent medicine with clear anti-tumor indications 2 weeks before the first dose; 11. Patients whose adverse reactions related to previous anti-tumor treatment have not recovered to CTCAE grade <= 1, except for toxicities judged by the researcher to have no safety risks, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.; 12. Have received organ transplantation or allogeneic hematopoietic stem cell transplantation in the past; 13. Participants taking systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent doses of other glucocorticoids) or other immunosuppressants within 14 days before the first dose of vaccination. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal hormone replacement at doses ≤10 mg/day of prednisone efficacy are allowed; 14. Get live vaccine/live attenuated vaccine/inactivated vaccine within 4 weeks before the first dose of vaccine; 15. Have received therapeutic tumor vaccines with similar targets in the past; 16. Suffering from bleeding diseases (such as coagulation factor deficiency, coagulation dysfunction [not suitable for inclusion as judged by the researcher]), or a history of obvious bruising or bleeding after injection or blood drawing; 17. Donate blood or lose a large amount of blood (>450 ml) within 3 months before screening, or plan to donate blood or blood components during the study; 18. Have undergone major surgery within 4 weeks before screening (catheter insertion, biopsy surgery required by the protocol and other minor surgeries are not excluded), or the impact of surgery or trauma has been eliminated for less than 14 days before enrollment; 19. Have a history of substance abuse or a known medical, psychological or social condition, such as a history of alcoholism or drug abuse; 20. Human immunodeficiency virus antibody test results are positive, and you have active syphilis (defined as a positive syphilis antibody test and a positive reagin test), or active hepatitis B (defined as HBV DNA ≥ 2000 IU/ml) or hepatitis C (defined as a positive HCV RNA test); 21. The patient has active TB (patients suspected of having active TB need to further visit the infectious disease department for a clear diagnosis) or a history of active TB; or severe acute or chronic infection that requires systemic treatment; 22. Pregnant or lactating women 23. Other circumstances in which the researcher deems it inappropriate to participate in this trial.

研究实施时间：

Study execute time：

从 From 2025-12-08 00:00:00至 To 2030-12-07 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-01-15 00:00:00 至 To 2027-12-08 00:00:00

干预措施：

Interventions：

组别：	YKYY031A组（第一阶段）	样本量：	36
Group：	YKYY031 group (the first stage)	Sample size：	36
干预措施：	经筛选合格后的参与者，按入组先后顺序依次进入A1-A6剂量组（低剂量到高剂量）, 每例参与者只接受一个相应的注射用YKYY031剂量，肌肉注射。	干预措施代码：
Intervention：	Eligible participants selected through screening will be sequentially assigned to dose groups A1 to A6 (in ascending order of dose) according to their enrollment sequence. Each participant will receive a single intramuscular injection of the corresponding dose of YKYY031 for injection.	Intervention code：

组别：	YKYY031 B组（第二阶段）	样本量：	40
Group：	YKYY031 group (the second stage)	Sample size：	40
干预措施：	根据剂量递增试验结果筛选1~2个剂量组进行注射用YKYY031单药或联合用药的剂量扩展试验，按入组先后顺序依次进入B1-B2剂量组（低剂量到高剂量）, 每例参与者只接受一个相应的注射用YKYY031剂量，肌肉注射。	干预措施代码：
Intervention：	Based on the results of the dose-escalation trial, 1–2 dose groups will be selected for the dose-expansion trial of YKYY031 for injection as monotherapy or in combination with other drugs. Eligible participants will be sequentially assigned to dose groups B1 to B2 (in ascending order of dose) according to their enrollment sequence. Each participant will receive a single intramuscular injection of the corresponding dose of YKYY031 for injection.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	北京	市(区县)：	北京
Country：	China	Province：	Beijing	City：	Beijing
单位(医院)：	北京肿瘤医院	单位级别：	三甲
Institution hospital：	Beijing Cancer Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	北京	市(区县)：	北京
Country：	China	Province：	Beijing	City：	Beijing
单位(医院)：	北京高博医院	单位级别：	三级
Institution hospital：	Beijing Go Broad Hospital	Level of the institution：	Tertiary

测量指标：

Outcomes：

指标中文名：	安全性评估	指标类型：	主要指标
Outcome：	Safety assessment	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	药代动力学	指标类型：	次要指标
Outcome：	Pharmacokinetics	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	免疫原性及免疫相关特征	指标类型：	次要指标
Outcome：	Immunogenicity and immune-related characteristics	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	生物标志物	指标类型：	附加指标
Outcome：	Biomarkers	Type：	Additional 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：	尿液	组织：
Sample Name：	Urine	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 section	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)：

NA

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	是Yes
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）：	采用网络平台公示原始数据。ResMan平台，http://www.medresman.org.cn/login.aspx
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	the original data was made public through a network platform. ResMan Platform:https://www.chictr.org.cn/resman/
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：	电子采集和管理
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Electronic Data Capture
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2025-12-19 09:30:25