ChiCTR2600116545 版本V1.0 版本创建时间2026/01/12 15:19:39 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600116545 

最近更新日期：

Date of Last Refreshed on：

2026-01-12 15:19:35 

注册时间：

Date of Registration：

2026-01-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评估177Lu-HX02注射液在晚期恶性实体瘤患者中的安全性、耐受性、辐射剂量学、药代动力学以及初步有效性的I期临床试验

Public title：

Phase I clinical trial to evaluate the safety, tolerability, radiation dosimetry, pharmacokinetics and preliminary efficacy of 177Lu-HX02 injection in patients with advanced malignant solid tumors

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评估177Lu-HX02注射液在晚期恶性实体瘤患者中的安全性、耐受性、辐射剂量学、药代动力学以及初步有效性的I期临床试验

Scientific title：

Phase I clinical trial to evaluate the safety, tolerability, radiation dosimetry, pharmacokinetics and preliminary efficacy of 177Lu-HX02 injection in patients with advanced malignant 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：

宗广楠 

研究负责人：

兰晓莉/陈静 

Applicant：

Zong Guangnan 

Study leader：

Lan Xiaoli/Chen Jing 

申请注册联系人电话：

Applicant telephone：

+86 176 6155 0692

研究负责人电话：

Study leader's telephone：

+86 138 8619 3262

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：

zongguangnan@hexin-med.com

研究负责人电子邮件：

Study leader's E-mail：

zongguangnan@hexin-med.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：

山东省菏泽市开发区长江东路现代医药港中央商务区257

研究负责人通讯地址：

湖北省武汉市解放大道1277号

Applicant address：

No. 257, Central Business District, Modern Medicine Port, East Changjiang Road, Development Zone, Heze City, Shandong Province

Study leader's address：

No. 1277, Jiefang Avenue, Wuhan City, Hubei Province

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：

核欣(苏州)医药科技有限公司核欣(菏泽)医药科技有限公司

Applicant's institution：

HeXin (Suzhou) Pharmaceutical Technology Co., Ltd. HeXin (Heze) Pharmaceutical Technology Co., Ltd.

研究负责人所在单位：

华中科技大学同济医学院附属协和医院

Affiliation of the Leader：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

[2025]伦审字(1146)号

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：

华中科技大学同济医学院附属协和医院医学伦理委员会

Name of the ethic committee：

The Medical Ethics Committee of Huazhong University of Science and Technology, Tongji Medical College Affiliated to Huazhong Association Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-04 00:00:00

伦理委员会联系人：

诸圆圆

Contact Name of the ethic committee：

Zhu Yuanyuan

伦理委员会联系地址：

湖北省武汉市解放大道1277号

Contact Address of the ethic committee：

No. 1277, Jiefang Avenue, Wuhan City, Hubei Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 27 8572 6375

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：

华中科技大学同济医学院附属协和医院

Primary sponsor：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究实施负责（组长）单位地址：

湖北省武汉市解放大道1277号

Primary sponsor's address：

No. 1277, Jiefang Avenue, Wuhan City, Hubei 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)：

湖北省

市(区县)：

武汉市

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

华中科技大学同济医学院附属协和医院

具体地址：

湖北省武汉市解放大道1277号

Institution
hospital：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address：

No. 1277, Jiefang Avenue, Wuhan City, Hubei Province

经费或物资来源：

核欣(苏州)医药科技有限公司核欣(菏泽)医药科技有限公司

Source(s) of funding：

HeXin (Suzhou) Pharmaceutical Technology Co., Ltd. HeXin (Heze) Pharmaceutical

Target disease：

Advanced malignant solid tumor

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：

横断面 

Study design：

Cross-sectional 

研究目的：

主要目的：评估 177Lu-HX02在晚期恶性实体瘤患者中的安全性和耐受性； 次要目的 评估177Lu-HX02在晚期恶性实体瘤患者中的辐射剂量学； 评估177Lu-HX02在晚期恶性实体瘤患者中的药代动力学特征； 评估177Lu-HX02的初步有效性。  

Objectives of Study：

Main objective: To evaluate the safety and tolerability of 177Lu-HX02 in patients with advanced malignant solid tumors; Secondary objectives To assess the radiation dosimetry of 177Lu-HX02 in patients with advanced malignant solid tumors; To evaluate the pharmacokinetic characteristics of 177Lu-HX02 in patients with advanced malignant solid tumors; To assess the preliminary effectiveness of 177Lu-HX02.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.对本研究已充分了解并自愿签署知情同意书； 2.年龄18~75周岁，男女不限； 3.ECOG评分0~1，能耐受PET/CT和SPECT/CT检查； 4.预计生存期>=6个月； 5.经组织学或细胞学确诊为晚期恶性实体瘤； 6.既往标准治疗失败； 7.68Ga-HX01 PET/CT显像阳性。定义为至少存在一个病灶在68Ga-HX01 PET/CT显像中SUVmax≥3.0或肿瘤与肝脏比值（SUVmax/SUVmean）（T/L ratio）> 1； 8.根据RECIST 1.1标准，至少有一个可测量的肿瘤病灶。对于既往进行过放射性治疗的病灶，仅当该病灶在放疗后出现明确疾病进展，方可将该病灶纳入可测量病灶； 9.既往抗肿瘤治疗（如既往化疗、放疗、靶向治疗、免疫治疗等）的毒性恢复到≤1级水平（脱发除外）； 10.器官的功能水平必须符合下列要求： a) 骨髓 中性粒细胞计数>=1.5×10^9/L且白细胞计数>=2.5×10^9/L； 血小板>=100×10^9/L； 血红蛋白>=90 g/L； b) 肝功能 总胆红素<=1.5×ULN（肝转移受试者总胆红素<=2×ULN）； 丙氨酸氨基转移酶（ALT）和天门冬氨酸氨基转移酶（AST）<3×ULN（肝转移受试者ALT和AST<5×ULN）； 白蛋白> 30 g/L； c) 肾功能 血清肌酐<=1.5×ULN且肌酐清除率>=50 mL/min； d) 凝血功能 国际标准化比值（INR）<=2.0，活化部分凝血活酶时间（APTT）<=1.5×ULN。例外情况：接受华法林抗凝治疗的受试者可接受INR 2至<=3； 11. 育龄期女性需妊娠试验阴性。具备生育能力的受试者（和伴侣）自愿在治疗期间和末次使用试验用药品后6个月内使用有效的避孕方法，例如避孕套、口服或注射避孕药物等。

Inclusion criteria

1. Have fully understood this research and voluntarily signed the informed consent form; 2. Age: 18 to 75 years old, gender not limited. 3. The ECOG score is 0 to 1, and it can tolerate PET/CT and SPECT/CT examinations. 4. Expected survival period: >=6 months; 5. Confirmed as advanced malignant solid tumor by histology or cytology; 6. Failure of previous standard treatment; 7.68Ga-HX01 positive PET/CT imaging. It is defined as the presence of at least one lesion with SUVmax≥3.0 or tumor-liver ratio (SUVmax/SUVmean) (T/L ratio) > 1 in 68Ga-HX01 PET/CT imaging; 8. According to the RECIST 1.1 standard, there is at least one measurable tumor lesion. For lesions that have undergone radiotherapy in the past, they can only be included in measurable lesions if there is a clear disease progression after radiotherapy. 9. The toxicity of previous anti-tumor treatments (such as previous chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) has recovered to a level of ≤ grade 1 (except for hair loss); 10. The functional level of organs must meet the following requirements: a) Bone marrow Neutrophil count >=1.5×10^9/L and white blood cell count >=2.5×10^9/L; Platelet count >=100×10^9/L; Hemoglobin >=90 g/L; b) Liver function Total bilirubin <=1.5×ULN (total bilirubin <=2×ULN for subjects with liver metastasis); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <3×ULN (ALT and AST<5×ULN in liver metastasis subjects); Albumin > 30 g/L; c) Renal function Serum creatinine <=1.5×ULN and creatinine clearance rate >=50 mL/min; d) Coagulation function International normalized ratio (INR) <=2.0, activated Partial thromboplastin time (APTT) <=1.5×ULN. Exceptional case: Subjects receiving warfarin anticoagulation therapy may receive an INR of 2 to <=3; 11. Women of childbearing age must have a negative pregnancy test. Fertile subjects (and their partners) voluntarily used effective contraceptive methods, such as condoms, oral or injectable contraceptives, during the treatment period and for six months after the last use of the investigational drug.

排除标准：

1. 177Lu-HX02给药前3个月内曾接受过放射性治疗药物，包括但不限于：镥-177、镭-223等； 2. 177Lu-HX02给药前4周内接受过大型手术、化疗、生物治疗、免疫治疗、内分泌治疗（激素替代除外）、大分子靶向治疗或未上市药物治疗。给药前2周内接受过局部姑息性放疗、有抗肿瘤适应症的中药、小分子靶向药物； 3. 在研究药物首次给药前2周内接受过输血、促红细胞生成素（EPO）、粒细胞集落刺激因子（G-CSF）、输注白蛋白及肾脏替代治疗； 4. 病史、计算机断层扫描（CT）或磁共振成像（MRI）检测提示存在中枢神经系统（CNS）转移灶。除外：中枢神经系统转移病灶经过放射治疗或手术治疗，首次给药前2周内未使用皮质醇类、抗惊厥类、脱水药物控制症状，影像学提示脑部病灶无进展或新发，且无神经系统症状者； 5. 患有严重的心血管疾病，包括但不限于以下情况： a) 给药前6个月内患有急性心肌梗塞、不稳定性心绞痛、接受过冠状动脉成形术或支架； b) 纽约心脏病协会Ⅱ至Ⅳ级充血性心力衰竭或左室射血分数（LVEF）＜50%或正常值下限； c) 未能控制的高血压（尽管使用了最优治疗，但收缩压>=160 mmHg和/或舒张压>=100 mmHg）； d) 基线期心电图QTcF间期延长（＞480 ms）； 6. 当前存在活动性感染，且需要接受系统性抗感染治疗（例如急性细菌感染、结核病、活动性乙型/丙型肝炎、活动性梅毒等）。活动性乙型肝炎定义为：HBsAg或HBcAb检测结果为阳性或者超出正常参考值范围者且伴随乙型肝炎病毒滴度＞2500拷贝/mL或500 IU /mL（受试者首次给药前接受抗乙肝病毒治疗至少14天，HBV-DNA降至<=2500拷贝/mL或500 IU /mL，且同意研究期间继续治疗者除外）；活动性丙型肝炎定义为：丙型肝炎抗体阳性或者超出正常参考值范围且HCV-RNA阳性；梅毒螺旋体特异性抗体阳性；HIV抗体阳性； 7. 需要激素治疗的非感染性肺炎以及放射性肺炎，引起血液动力学改变的血栓事件、存在活动性出血事件或其他严重的合并症； 8. 177Lu-HX02给药前五年内患有任何其他活动性恶性肿瘤（除外已根治性切除且未复发的皮肤基底细胞癌、皮肤鳞状细胞癌、浅表性膀胱癌、局部前列腺癌、原位宫颈癌或其他原位癌）； 9. 已知对研究药物或其类似物的成分过敏； 10. 任何原因导致的排尿困难者或尿失禁者； 11. 患有幽闭恐惧症等不能配合做PET/CT或SPECT/CT检查的情况； 12. 精神疾病如：抑郁症、精神分裂症、妄想、幻觉或自杀意念等患者； 13. 处于哺乳期的女性； 14. 研究者认为受试者不适合参加本研究的其他情况。

Exclusion criteria：

1. Within the 3 months prior to the administration of 177Lu-HX02, the subject had received radiotherapy drugs, including but not limited to: lutetium-177, radium-223, etc. 2. Within the 4 weeks prior to the administration of 177Lu-HX02, the subject had undergone major surgery, chemotherapy, biological therapy, immunotherapy, endocrine therapy (except hormone replacement), large molecule targeted therapy or off-label drug treatment. Within the 2 weeks prior to administration, the subject had received local palliative radiotherapy, traditional Chinese medicine with anti-tumor indications, small molecule targeted drugs. 3. Within 2 weeks prior to the first administration of the study drug, the subject had received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), albumin infusion and renal replacement therapy. 4. The medical history, computed tomography (CT) or magnetic resonance imaging (MRI) examination indicated the presence of central nervous system (CNS) metastatic lesions. Excluding: CNS metastatic lesions that have undergone radiotherapy or surgery, the subject did not use corticosteroids, anticonvulsants, or diuretics to control symptoms within 2 weeks prior to the first administration, the imaging indicated no progression or new onset of brain lesions, and there were no neurological symptoms. 5. Suffering from severe cardiovascular diseases, including but not limited to the following conditions: a) Within 6 months prior to administration, suffered from acute myocardial infarction, unstable angina pectoris, or received coronary angioplasty or stent; b) New York Heart Association class II to IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50% or within the lower limit of the normal range; c) Uncontrolled hypertension (even with optimal treatment, with systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >=100 mmHg); d) Baseline electrocardiogram QTcF interval prolonged (> 480 ms); 6. Currently has active infection and requires systemic anti-infection treatment (such as acute bacterial infection, tuberculosis, active hepatitis B/ C, active syphilis, etc.). Active hepatitis B is defined as: HBsAg or HBcAb test result is positive or exceeds the normal reference range, accompanied by hepatitis B virus titer > 2500 copies/mL or 500 IU/mL (excluding subjects who received anti-hepatitis B virus treatment for at least 14 days, HBV-DNA<= 2500 copies/mL or 500 IU/mL, and agreed to continue treatment during the study period); Active hepatitis C is defined as: hepatitis C antibody positive or exceeds the normal reference range and HCV-RNA positive; Treponema pallidum specific antibody positive; HIV antibody positive; 7. Non-infectious pneumonia requiring hormone treatment and radiation pneumonitis, hemodynamic-altering thrombotic events, active bleeding events or other serious complications; 8. Within the 5 years prior to the administration of 177Lu-HX02, the subject had any other active malignant tumors (excluding surgically resected and non-recurrent skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, local prostate cancer, in situ cervical cancer or other in situ cancers); 9. Known to be allergic to the components of the study drug or its analogues; 10. Any person with difficulty in urination or urinary incontinence; 11. Suffering from claustrophobia or other conditions that prevent cooperation in PET/CT or SPECT/CT examinations; 12. Patients with mental disorders such as depression, schizophrenia, delusion, hallucination or suicidal ideation; 13. Pregnant women; 14. Other situations that the investigator considers the subject is not suitable to participate in this study.

研究实施时间：

Study execute time：

从 From 2025-12-02 00:00:00至 To 2028-04-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-12 00:00:00 至 To 2027-03-01 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

24

Group：

Experimental Group

Sample size：

干预措施：

本研究共预设以下4个递增剂量：50 mCi、100 mCi、150 mCi、200mCi。每个剂量进行 1次给药。在试验期间，将由根据研究者、申办者审查试验中产生的安全性/耐受性、 PK、辐射剂量学数据以及器官耐受剂量限制等数据，共同讨论后是否进行下一个剂量的探索；此外，研究者、申办者也将根据试验数据决定是否调整剂量递增方案（包括调整剂量递增幅度、允许选择中间剂量进行研究等）以探索 RP2D/后续推荐剂量。 采用加速滴定和 “3+3”剂量递增设计。自177Lu-HX02治疗起 42天内，为剂量限制性毒性（DLT）观察期。

干预措施代码：

Intervention：

A total of four incremental doses were preset in this study: 50 mCi, 100 mCi, 150 mCi, and 200mCi. Each dose is administered once. During the trial period, based on the safety/tolerability, PK, radiation dosimetry data, and organ tolerance dose limits generated during the trial by the researcher and the sponsor, a joint discussion will be held to determine whether to proceed with the exploration of the next dose. In addition, researchers and sponsors will also decide whether to adjust the dose escalation protocol (including adjusting the dose escalation magnitude and allowing the selection of intermediate doses for research, etc.) based on the trial data to explore RP2D/ subsequent recommended doses. It adopts accelerated titration and a "3+3" dose escalation design. The period of 42 days from the treatment with 177Lu-HX02 is the dose-limiting toxicity (DLT) observation period.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北 

市(区县)：

  

Country：

China 

Province：

Hubei 

City：

 

单位(医院)：

华中科技大学同济医学院附属协和医院 

单位级别：

三甲 

Institution
hospital：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

安全性：不良事件（AE）、生命体征、体格检查、12导联心电图和实验室检查等

指标类型：

主要指标

Outcome：

Safety: Adverse events (AE), vital signs, physical examination, 12-lead electrocardiogram and laboratory tests, etc.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

耐受性：剂量限制性毒性（DLT）发生率

指标类型：

主要指标

Outcome：

Tolerance: Incidence of dose-limiting toxicity (DLT)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

探索MTD及确定RP2D/后续推荐剂量。

指标类型：

主要指标

Outcome：

Explore MTD and determine RP2D/ subsequent recommended dose.

Type：

Primary 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：

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：

无

Blinding：

None

是否共享原始数据：

IPD sharing

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）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

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：

EDC

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

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：

  2026-01-12 15:19:35