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：	ChiCTR2600126786
最近更新日期： Date of Last Refreshed on：	2026-06-16 09:27:30
注册时间： Date of Registration：	2026-06-16 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	维贝柯妥塔单抗治疗局晚或转移性尿路鳞癌临床研究
Public title：	Clinical Study of Vibecotamab for Locally Advanced or Metastatic Squamous Cell Carcinoma of the Urinary Tract
注册题目简写：
English Acronym：
研究课题的正式科学名称：	维贝柯妥塔单抗（MRG003）治疗不可手术切除的局部晚期或转移性尿路鳞癌的前瞻性、单臂、开放标签、II 期临床研究
Scientific title：	A Prospective, Single-Arm, Open-Label Phase II Clinical Study of Vibecotamab (MRG003) in the Treatment of Unresectable Locally Advanced or Metastatic Squamous Cell Carcinoma of the Urinary Tract
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：	郑润壕	研究负责人：	尧凯
Applicant：	Zheng Runhao	Study leader：	Kai Yao
申请注册联系人电话： Applicant telephone：	+86 15626213328	研究负责人电话： Study leader's telephone：	+86 20 8734 3840
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：	zhengrh@sysucc.org.cn	研究负责人电子邮件： Study leader's E-mail：	yaokai@sysucc.org.cn
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：	中国广东省广州市越秀区东风东路651号	研究负责人通讯地址：	广州市越秀区东风东路651号
Applicant address：	No. 651 Dongfeng East Road, Yuexiu District, Guangzhou, Guangdong	Study leader's address：	No. 651 Dongfeng East Road, Yuexiu District, Guangzhou, Guangdong
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：	中山大学肿瘤防治中心
Applicant's institution：	Sun Yat-sen University Cancer Center
研究负责人所在单位：	中山大学肿瘤防治中心
Affiliation of the Leader：	Sun Yat-sen University Cancer Center

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：	B2026-255-01	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：	中山大学肿瘤防治中心伦理委员会
Name of the ethic committee：	Ethics Committee of Sun Yat-sen University Cancer Center
伦理委员会批准日期： Date of approved by ethic committee：	2026-05-12 00:00:00
伦理委员会联系人：	潘旭芝
Contact Name of the ethic committee：	Pan XuZhi
伦理委员会联系地址：	广州市越秀区东风东路651号
Contact Address of the ethic committee：	No. 651 Dongfeng East Road, Yuexiu District, Guangzhou, Guangdong
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 20 87343009	伦理委员会联系人邮箱： Contact email of the ethic committee：	panxzh@sysucc.org.cn

研究实施负责（组长）单位：

中山大学肿瘤防治中心

Primary sponsor：

Sun Yat-sen University Cancer Center

研究实施负责（组长）单位地址：

广州市越秀区东风东路651号

Primary sponsor's address：

No. 651 Dongfeng East Road, Yuexiu District, Guangzhou, Guangdong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	中山大学肿瘤防治中心	具体地址：	广州市越秀区东风东路651号
Institution hospital：	Sun Yat-sen University Cancer Center	Address：	No. 651 Dongfeng East Road, Yuexiu District, Guangzhou, Guangdong

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected Project (Self-funded)

研究疾病：

尿路鳞癌

Target disease：

Urothelial carcinoma

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：

II期临床试验

Study phase：

2

研究设计：

单臂

Study design：

Single arm

研究目的：

1.评价 MRG003 治疗不可手术切除的局晚或转移性尿路鳞癌（la/m sqUC）的疗效； 2.评价 MRG003 治疗不可手术切除的局晚或转移性尿路鳞癌（la/m sqUC）的安全性。

Objectives of Study：

1.To evaluate the efficacy of MRG003 in the treatment of unresectable locally advanced or metastatic squamous cell carcinoma of the urinary tract (la/m sqUC); 2.To evaluate the safety of MRG003 in the treatment of unresectable locally advanced or metastatic squamous cell carcinoma of the urinary tract (la/m sqUC).

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

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:

1. Voluntary participation in the clinical study; providing written informed consent after fully understanding and being informed about the study; willing and able to comply with all study procedures.
2. Aged >= 18 years.
3. Histopathologically confirmed pure urothelial squamous cell carcinoma or urothelial carcinoma with squamous differentiation (squamous component > 70%) by the Department of Pathology of our hospital; primary tumor sites include the renal pelvis, ureter, bladder, or urethra (pathological staging according to the AJCC TNM Staging Manual, 8th Edition).
4. Patients with pathologically confirmed unresectable locally advanced (T4N0M0 or TxN1-3M0) or metastatic (TxNxM1) urothelial squamous cell carcinoma (first-line or above).
5. Availability of tumor paraffin-embedded tissue blocks for EGFR immunohistochemistry (IHC) and other assays (EGFR IHC testing will be independently performed and interpreted by the Department of Pathology, Sun Yat-sen University Cancer Center).
6. Ineligibility for radical surgical resection, or presence of distant metastatic lesions (M1).
7. Presence of measurable disease according to RECIST version 1.1.
8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 and an expected survival time >= 6 months.
9. Organ and hematopoietic function meeting the following requirements:
   (1) Hemoglobin (HGB) >= 80 g/L;
   (2) White blood cell count (WBC) >= 3 x 10^9/L;
   (3) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L;
   (4) Platelet count (PLT) >= 80 x 10^9/L;
   (5) Total bilirubin <= 1.5 x Upper Limit of Normal (ULN);
   (6) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 x ULN, or <= 5 x ULN (for patients with liver metastases);
   (7) Serum creatinine (Cr) <= 2.5 x ULN; or endogenous creatinine clearance rate (CCr) >= 30 mL/min.

排除标准：

1.病理合并小细胞/神经内分泌分化、肉瘤样分化需排除；
2.病灶可行根治性切除且患者耐受根治性手术；
3.患者既往曾经使用含MMAE抗肿瘤药物的治疗；
4.伴有严重的内科疾病，如严重感染、不能控制的糖尿病、心血管疾病（纽约心脏病协会分级定义的Ⅲ级或Ⅳ级心衰、Ⅱ度以上心脏传导阻滞、过去1个月内发生心肌梗塞、不稳定性心律失常或不稳定性心绞痛、1个月内发生脑梗塞等）或严重肺部疾病（间质性肺炎、重度阻塞性肺病和有症状的支气管痉挛病史）者或有临床症状的肝脏、肾脏及血液内分泌系统或神经精神疾病史；
5.已知有人类免疫缺陷病毒（HIV）感染史（即HIV1/2抗体阳性）；
6.给药前HBV病毒载量必须<1000拷贝/ml（200IU/ml），受试者应在整个研究化疗药物治疗期间接受抗HBV治疗避免病毒再激活。对于抗HBc（+）、HBsAg（-）、抗HBs（-）和HBV病毒载量（-）的受试者，不需要接受预防性抗HBV治疗，但是需要密切监测病毒再激活）；
7.首次给药之前（第1周期，第1天）30天内接种过活疫苗（注：允许首次给药前30天内接受针对季节性流感的注射用灭活病毒疫苗,但是不允许接受鼻内用药的减毒活流感疫苗）；
8.伴随其它活动性癌症，或过去的五年内有其他恶性肿瘤的病史。除外以下情况：①已治愈的皮肤非恶性黑色素癌；②治愈性的肿瘤：包括宫颈原位癌、表浅的膀胱癌；③其他实体肿瘤，已接受根治性治疗，5年或以上未见复发转移；
9.既往有明确的神经或精神障碍史，如癫痫、痴呆，依从性差者；
10.有吸毒或药物滥用史；
11.可能增加参与研究和研究用药风险、或者可能会干扰研究结果解释的其他重度、急性、或慢性疾病或实验室检查异常情况；
12.研究者认为由于其他原因不适合参加该研究者；

Exclusion criteria：

1. Histopathological evidence of small cell/neuroendocrine differentiation or sarcomatoid differentiation. 2. Eligibility for radical resection and patient tolerance of radical surgery. 3. Prior treatment with MMAE-containing anti-tumor agents. 4. Presence of severe medical conditions, such as severe infection, uncontrolled diabetes, cardiovascular diseases (NYHA Class III or IV heart failure, atrioventricular block >= Grade II, myocardial infarction within the past month, unstable arrhythmias, or unstable angina), or severe pulmonary diseases (interstitial pneumonia, severe obstructive pulmonary disease, or a history of symptomatic bronchospasm); or a history of symptomatic liver, kidney, hematological, endocrine, neurological, or psychiatric disorders. 5. Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV-1/2 antibodies). 6. Active hepatitis B requiring treatment. However, subjects meeting the following criteria are eligible: HBV DNA viral load must be < 1000 copies/mL (200 IU/mL) prior to the first dose. Subjects must receive anti-HBV therapy throughout the study chemotherapy period to prevent viral reactivation. Subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV DNA (-) do not require prophylactic anti-HBV therapy but need close monitoring for viral reactivation. 7. Receipt of live vaccines within 30 days prior to the first administration (Cycle 1, Day 1). Note: Inactivated influenza vaccines administered via injection are permitted within 30 days prior to the first dose; however, intranasal attenuated live influenza vaccines are prohibited. 8. Concurrent active malignancy or a history of other malignancies within the past five years, except for: (1) Cured non-melanoma skin cancer; (2) Curatively treated tumors including cervical carcinoma in situ and superficial bladder cancer; (3) Other solid tumors that have undergone radical treatment with no recurrence or metastasis for 5 years or longer. 9. History of definite neurological or psychiatric disorders, such as epilepsy or dementia, or poor compliance. 10. History of drug abuse or substance dependence. 11. Other severe, acute, or chronic medical conditions or abnormal laboratory findings that might increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results. 12. Deemed unsuitable for participation in the study by the investigator for other reasons.

研究实施时间：

Study execute time：

从 From 2026-07-01 00:00:00至 To 2029-07-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-07-01 00:00:00 至 To 2029-07-31 00:00:00

干预措施：

Interventions：

组别：	MRG003	样本量：	31
Group：	MRG003	Sample size：	31
干预措施：	维贝柯妥塔单抗（MRG003）：2.3mg/kg，ivd，d1，Q3W 治疗直至疾病复发或进展，或出现不可耐受的毒性	干预措施代码：
Intervention：	Vibekototumab (MRG003): 2.3 mg/kg, IV drip, day 1, every 3 weeks. Treat until the disease relapses or progresses, or until intolerable toxicity occurs.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	中山大学肿瘤防治中心	单位级别：	三级甲等
Institution hospital：	Sun Yat-sen University Cancer Center	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	疾病控制率	指标类型：	次要指标
Outcome：	Disease Control Rate	Type：	Secondary indicator
测量时间点：	筛选期、每 6 周用药后、治疗终止随访	测量方法：	CT、MR、超声等检查
Measure time point of outcome：	Screening period, after medication every 6 weeks, at follow-up upon treatment discontinuation	Measure method：	Imaging examinations such as CT, MRI, and ultrasound

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：	筛选期、每 6 周用药后、治疗终止随访	测量方法：	CT、MR、超声等检查
Measure time point of outcome：	Screening period, after medication every 6 weeks, at follow-up upon treatment discontinuation	Measure method：	Imaging examinations such as CT, MRI, and ultrasound

指标中文名：	总生存时间	指标类型：	次要指标
Outcome：	Overall Survival	Type：	Secondary indicator
测量时间点：	患者死亡时	测量方法：
Measure time point of outcome：	At patient death	Measure method：

指标中文名：	无进展生存时间	指标类型：	次要指标
Outcome：	Progression-Free Survival	Type：	Secondary indicator
测量时间点：	筛选期、每 6 周用药后、治疗终止随访	测量方法：	CT、MR、超声等检查
Measure time point of outcome：	Screening period, after medication every 6 weeks, at follow-up upon treatment discontinuation	Measure method：	Imaging examinations such as CT, MRI, and ultrasound

指标中文名：	生活质量评分	指标类型：	次要指标
Outcome：	Quality of Life	Type：	Secondary indicator
测量时间点：	入组项目起至出组，每 3 个月进行一次 QoL 量表评分	测量方法：	定期填写EORTC QLQ-C30量表
Measure time point of outcome：	QoL questionnaire administered every 3 months from study entry until study discontinuation	Measure method：	Complete the EORTC QLQ-C30 questionnaire at regular intervals.

指标中文名：	安全性不良事件发生率	指标类型：	次要指标
Outcome：	Treatment Emergent Adverse Event Rate	Type：	Secondary indicator
测量时间点：	每次访视、不良事件随时记录	测量方法：
Measure time point of outcome：	At each visit; adverse events documented as they occur	Measure method：

指标中文名：	缓解持续时间	指标类型：	次要指标
Outcome：	Duration of Response	Type：	Secondary indicator
测量时间点：	确认缓解后全程随访至进展	测量方法：	CT、MR、超声等检查
Measure time point of outcome：	Follow up from confirmed response until disease progression	Measure method：	Imaging examinations such as CT, MRI, and ultrasound

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	组织	组织：
Sample Name：	tumor	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		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：	无
Blinding：	None

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）：	原始数据将上传至中山大学肿瘤防治中心RDD原始数据备案平台(www.researchdata.org.cn)。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	The raw data supporting the conclusions of this article will be made available by the authors.The authenticity of this article has beenvalidated by uploading the key raw data onto the Research Data Deposit platform (www.researchdata.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：	遵照ICH/GCP指南，研究者/机构将维护支持从每名受试者采集数据的CRF和所有源文档、临床研究实施重要文件中规定的所有研究文档，与适用法规要求规定的所有研究文档。研究者/机构将采取措施防止意外或过早销毁这些文档。重要的文档必须加以保留，直至研究药物临床研发正式中止后至少过去2年为止。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data colection and Management: in compliance with ICH/Gcp guidelines, the investigatorlinstitution will maintain all studvdocuments stipulated in the CRF supporting data colection from each subiect. all source documents, and key documents for clinicastudy conduct, as well as all study documents required by applicable regulatory requirements, The investigatorinstitution wil takemeasures to nrevent accidental or premature destruction of these documents. mportant documents must be retained for at least 2years after the official discontinuation of clinical development of the study drug.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-06-16 09:27:10