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：	ChiCTR2600120503
最近更新日期： Date of Last Refreshed on：	2026-03-16 12:01:23
注册时间： Date of Registration：	2026-03-16 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	一项评估维贝柯妥塔单抗（MRG003）单药或联合贝伐珠单抗治疗EGFR阳性铂耐药上皮性卵巢癌/输卵管癌/原发性腹膜癌的有效性和安全性的Ⅱ期临床研究
Public title：	A phase II clinical study to evaluate the efficacy and safety of MRG003 (Becotatug Vedotin) as a monotherapy or in combination with bevacizumab in the treatment of EGFR-positive platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项评估维贝柯妥塔单抗（MRG003）单药或联合贝伐珠单抗治疗EGFR阳性铂耐药上皮性卵巢癌/输卵管癌/原发性腹膜癌的有效性和安全性的Ⅱ期临床研究
Scientific title：	A phase II clinical study to evaluate the efficacy and safety of MRG003 (Becotatug Vedotin) as a monotherapy or in combination with bevacizumab in the treatment of EGFR-positive platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
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：	蓝春燕	研究负责人：	蓝春燕
Applicant：	Lan Chunyan	Study leader：	Lan Chunyan
申请注册联系人电话： Applicant telephone：	+86 189 2880 6306	研究负责人电话： Study leader's telephone：	+86 189 2880 6306
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：	lanchy@sysucc.org.cn	研究负责人电子邮件： Study leader's E-mail：	lanchy@sysucc.org.cn
申请单位网址(自愿提供)： Applicant website(voluntary supply)：	中山大学肿瘤防治中心	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：	广州市东风东路651号	研究负责人通讯地址：	广州市东风东路651号
Applicant address：	651, Dongfeng Road, Guangzhou	Study leader's address：	651, Dongfeng Road, Guangzhou
申请注册联系人邮政编码： Applicant postcode：	510060	研究负责人邮政编码： Study leader's postcode：	510060
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：	SL-B2026-025-02	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：	The Ethics Committee of the National Sun Yat-sen University Cancer Center
伦理委员会批准日期： Date of approved by ethic committee：	2026-02-09 00:00:00
伦理委员会联系人：	符立梧
Contact Name of the ethic committee：	Fu Liwu
伦理委员会联系地址：	广东省广州市东风东路651号
Contact Address of the ethic committee：	No. 651, Dongfeng East Road, Guangzhou, Guangdong Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 29 8734 3009	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：

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：

广东省广州市东风东路651号

Primary sponsor's address：

No. 651, Dongfeng East Road, Guangzhou, Guangdong Province

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	市(区县)：	广州
Country：	China	Province：	Guangdong	City：	Guangzhou
单位(医院)：	中山大学肿瘤防治中心	具体地址：	广州市东风东路651号
Institution hospital：	Sun Yat-sen University Cancer Center	Address：	651, Dongfeng Road, Guangzhou

经费或物资来源：

研究发起者科研经费

Source(s) of funding：

Research funding from the sponsor

研究疾病：

上皮性卵巢癌/输卵管癌/原发性腹膜癌

Target disease：

Epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer

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：

主要目的：队列1： • 评价维贝柯妥塔单抗单药治疗EGFR阳性铂耐药上皮性卵巢癌/输卵管癌/原发性腹膜癌的疗效。队列2： • 评价维贝柯妥塔单抗联合贝伐珠单抗治疗EGFR阳性铂耐药上皮性卵巢癌/输卵管癌/原发性腹膜癌的疗效。次要目的：队列1： • 评价维贝柯妥塔单抗治疗EGFR阳性铂耐药上皮性卵巢癌/输卵管癌/原发性腹膜癌的安全性和耐受性。队列2： • 评价维贝柯妥塔单抗联合贝伐珠单抗治疗EGFR阳性铂耐药上皮性卵巢癌/输卵管癌/原发性腹膜癌的安全性和耐受性。探索性目的： • 探索维贝柯妥塔单抗单药或联合贝伐珠单抗治疗EGFR阳性铂耐药上皮性卵巢癌/输卵管癌/原发性腹膜癌的疗效相关的生物标志物。

Objectives of Study：

Primary objective: Cohort 1: • To evaluate the efficacy of vibectocetaxel as monotherapy in patients with EGFR-positive platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Cohort 2: • To evaluate the efficacy of vibectocetaxel in combination with bevacizumab in patients with EGFR-positive platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Secondary objectives: Cohort 1: • To evaluate the safety and tolerability of vibectocetaxel in the treatment of EGFR-positive platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Cohort 2: • To evaluate the safety and tolerability of vibectocetaxel in combination with bevacizumab in the treatment of EGFR-positive platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Exploratory Objectives: • To explore biomarkers related to the efficacy of vibectinototag monoclonal antibody as a monotherapy or in combination with bevacizumab in the treatment of EGFR-positive platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

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. Subjects voluntarily participated in this study, signed the informed consent form, and had good compliance.
2. Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer confirmed by histology.
3. EGFR protein expression positive confirmed by IHC.
4. Platinum-resistant relapsed patients, defined as disease progression during the most recent platinum-based chemotherapy or within 6 months after the last platinum-based chemotherapy. After confirming platinum resistance, subjects are allowed to receive subsequent non-platinum treatment regimens.
5. Age 18-75 years.
6. At least one measurable lesion according to RECIST v1.1 criteria.
7. Eastern Cooperative Oncology Group (ECOG) performance score 0-1.
8. Expected survival of more than 3 months.
9. Cohort 2: Time since last bevacizumab use >= 6 months.
10. Normal major organ function, as defined by the following criteria: absolute neutrophil count >= 1.5×10^9, platelets >= 100×10^9, hemoglobin >= 90g/L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5×upper limit of normal (UNL), total bilirubin < 1.5×UNL, serum creatinine < 1.5×UNL.
11. Subjects with potential fertility must use at least one medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study treatment and for 180 days after the end of the study treatment; and a negative serum/urine HCG test must be obtained before the first dose; and must not be in the lactation period.

排除标准：

1.已知对研究中的任何药物存在过敏者； 2.既往抗肿瘤治疗（包括免疫治疗、靶向治疗、化疗或放疗等）导致的遗留毒性反应（脱发、疲乏和2级甲减除外）或有临床意义的实验室检测异常值高于1级（CTCAE v5.0）； 3.需要治疗的严重或无法控制的心脏疾病或临床症状，包括： • 首次给药6个月内，美国纽约心脏病协会（NYHA）分级为3级或4级的充血性心力衰竭或左室射血分数（LVEF）＜50％； • 首次给药6个月内，药物无法控制的不稳定型心绞痛，心肌梗塞病史和心肌炎，控制不良的心律失常（房颤或阵发性室上性心动过速除外，包括QTc间期男性 ≥ 450 ms、女性 ≥ 470 ms）（QTc间期以Fridericia 公式计算）； 4.首次给药前6个月内发生的动静脉血栓事件，如脑血管意外（包括暂时性缺血性发作）、深静脉血栓（因前期化疗行静脉置管引发静脉血栓经研究者判断已痊愈者除外）、肺栓塞或近期的外周动脉血栓行成等； 5.有活动性的溃疡、肠穿孔、肠梗阻者 6.有活动性出血或出血倾向者； 7.患有高血压，且经降压药物治疗无法获得良好控制（收缩压 ≥ 140 mmHg或者舒张压 ≥ 90 mmHg）； 8.研究药物首次给药前3周内接受过系统性化疗；首次给药前2周内或5个半衰期内（以时间长者为准）接受过小分子靶向治疗；首次给药前28天内，接受过重大手术（本研究重大手术定义：术后至少需要3周恢复时间，才能够接受本研究治疗的手术）； 9.尿常规提示尿蛋白≥ ++并经证实24小时尿蛋白量>1.0g； 10.通过适当干预后无法控制的胸腔积液、心包积液或腹水； 11.五年内有其他恶性肿瘤病史，已治愈的宫颈原位癌或皮肤基底细胞癌除外； 12.HIV阳性； 13.有症状的脑转移者(已经证实或怀疑)； 14.研究者认为受试者存在任何临床或实验室检查异常或其他原因而不适合参加本临床研究。

Exclusion criteria：

1. Known allergies to any medication used in the study; 2. Persistent toxic effects (excluding alopecia, fatigue, and grade 2 hypothyroidism) or clinically significant laboratory abnormalities exceeding grade 1 (CTCAE v5.0) resulting from prior antineoplastic therapy (including immunotherapy, targeted therapy, chemotherapy, or radiotherapy); 3. Severe or uncontrolled cardiac disease or clinical symptoms requiring treatment, including: • Congestive heart failure classified as NYHA Class 3 or 4 or left ventricular ejection fraction (LVEF) <50% within 6 months after the first dose; • Unstable angina not controlled by medication within 6 months of the first dose, history of myocardial infarction or myocarditis, poorly controlled arrhythmias (excluding atrial fibrillation or paroxysmal supraventricular tachycardia, including QTc interval >= 450 ms in males or >= 470 ms in females) (QTc interval calculated using the Fridericia formula); 4. Arteriovenous thrombotic events occurring within 6 months prior to the first dose of medication, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (excluding cases where venous thrombosis was caused by prior chemotherapy-related venous catheterization and deemed resolved by the investigator), pulmonary embolism, or recent peripheral arterial thrombosis formation; 5. Individuals with active ulcers, intestinal perforation, or intestinal obstruction 6. Those with active bleeding or a tendency to bleed; 7. Suffering from hypertension that cannot be adequately controlled with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); 8. Received systemic chemotherapy within 3 weeks before the first administration of the study drug; received small molecule targeted therapy within 2 weeks before the first administration or within 5 half-lives (whichever is longer); underwent major surgery within 28 days before the first administration (major surgery in this study is defined as surgery requiring at least 3 weeks of postoperative recovery time before participating in the study); 9. Urinalysis indicates proteinuria >= ++ and confirms a 24-hour urinary protein excretion >1.0g; 10. Uncontrollable pleural effusion, pericardial effusion, or ascites despite appropriate intervention; 11. History of other malignant tumors within the past five years, excluding cured cervical in situ cancer or basal cell carcinoma of the skin; 12. HIV positive; 13. Symptomatic brain metastasis patients (confirmed or suspected); 14. The researchers believe that the subjects have any clinical or laboratory abnormalities or other reasons that make them ineligible to participate in this clinical study.

研究实施时间：

Study execute time：

从 From 2026-03-15 00:00:00至 To 2029-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-03-16 00:00:00 至 To 2029-12-31 00:00:00

干预措施：

Interventions：

组别：	队列1	样本量：	20
Group：	Cohort 1	Sample size：	20
干预措施：	给予维贝柯妥塔单抗，每3周为一个给药周期，每周期第1天给予维贝柯妥塔单抗2.3mg/kg，静脉滴注。	干预措施代码：
Intervention：	Administer Becotatug Vedotin at a dose of 2.3 mg/kg intravenously on day 1 of each 3-week treatment cycle.	Intervention code：

组别：	队列2	样本量：	34
Group：	Cohort 2	Sample size：	34
干预措施：	维贝柯妥塔单抗 + 贝伐珠单抗维贝柯妥塔单抗：每3周为一个给药周期，每周期第1天给予维贝柯妥塔单抗2.0 或 1.5 mg/kg，静脉滴注。贝伐珠单抗：每3周为一个给药周期，每周期第1天给予贝伐珠单抗15mg/kg，静脉滴注。	干预措施代码：
Intervention：	Becotatug Vedotin plus Bevacizumab Becotatug Vedotin: The dosing cycle is every 3 weeks, with 2.0 or 1.5 mg/kg administered on the first day of each cycle via intravenous infusion. Bevacizumab: Administer 15 mg/kg of bevacizumab intravenously on the first day of each 3-week dosing cycle.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广东	市(区县)：
Country：	China	Province：	Guang Dong	City：
单位(医院)：	中山大学肿瘤防治中心	单位级别：	三甲
Institution hospital：	Sun Yat-sen University Cancer Center	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	客观有效率	指标类型：	主要指标
Outcome：	Objective response rate(ORR)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	无进展生存	指标类型：	次要指标
Outcome：	Progression-free survival,PFS	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	疾病控制率	指标类型：	次要指标
Outcome：	Disease control rate,DCR	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		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,DoR	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	总生存时间	指标类型：	次要指标
Outcome：	overall survival, OS	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	根据FACT-O的生活质量调查问卷结果	指标类型：	次要指标
Outcome：	According to the results of the FACT-O quality of life survey questionnaire	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：	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：

女性

Gender：

Female

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）：	不共享
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Not sharing
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：	病例记录表和电子采集管理系统
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF and 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：	2026-03-16 12:01:06