注册号：
Registration number：
ChiCTR2600122142 最近更新日期：
Date of Last Refreshed on：
2026-04-09 11:55:02 注册时间：
Date of Registration：
2026-04-09 00:00:00 注册号状态：
补注册Registration Status：
Retrospective registration注册题目：
评价注射用莱古比星单药治疗晚期恶性实体瘤患者的安全性、耐受性、药代动力学特征以及初步疗效的开放、剂量递增及剂量拓展的I期临床试验Public title：
Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy Legubicin for 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：
评价注射用莱古比星单药治疗晚期恶性实体瘤患者的安全性、耐受性、药代动力学特征以及初步疗效的开放、剂量递增及剂量拓展的I期临床试验Scientific title：
Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy Legubicin for 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：
孙辉
研究负责人：
李进 Applicant：
Hui Sun
Study leader：
Jin Li 申请注册联系人电话：
Applicant telephone：
+86 189 1540 7782
研究负责人电话：
Study leader's telephone：
+86 137 6122 2111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：
sunhui@affinity.net.cn
研究负责人电子邮件：
Study leader's E-mail：
lijin@csco.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：
上海市浦东新区蔡伦路781号1303室
研究负责人通讯地址：
上海市浦东新区即墨路150号Applicant address：
Room 1303, Building 781, Cailun Road, Pudong New Area, Shanghai
Study leader's address：
No. 150, Jimo Road, Pudong New Area, 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：
上海亲合力生物医药科技股份有限公司Applicant's institution：
Shanghai Affinity Biomedical Technology Co., LTD研究负责人所在单位：
同济大学附属东方医院Affiliation of the Leader：
The East Hospital Affiliated to Tongji University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：
2019临审第(084)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：
上海市东方医院药物临床试验伦理委员会Name of the ethic committee：
Independent Ethics Committee伦理委员会批准日期：
Date of approved by ethic committee：
2019-12-26 00:00:00伦理委员会联系人：
鲍思蔚Contact Name of the ethic committee：
Siwei Bao伦理委员会联系地址：
上海市浦东新区即墨路150号Contact Address of the ethic committee：
No. 150, Jimo Road, Pudong New Area, Shanghai伦理委员会联系人电话：
Contact phone of the ethic committee：
+86 21 3880 4518
伦理委员会联系人邮箱：
Contact email of the ethic committee：
siweibao@163.com研究实施负责（组长）单位：
同济大学附属东方医院Primary sponsor：
The East Hospital Affiliated to Tongji University研究实施负责（组长）单位地址：
上海市浦东新区即墨路150号Primary sponsor's address：
No. 150, Jimo Road, Pudong New Area, 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)：
上海亲合力生物医药科技股份有限公司
具体地址：
上海市浦东新区蔡伦路781号1303室
Institution
hospital：
Shanghai Affinity Biomedical Technology Co., LTD
Address：
Room 1303, Building 781, Cailun Road, Pudong New Area, Shanghai?经费或物资来源：
上海亲合力生物医药科技股份有限公司Source(s) of funding：
Shanghai Affinity Biomedical Technology Co., LTD研究疾病：
晚期实体瘤 Target disease：
late-stage solid tumor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：
评价注射用莱古比星单药在标准治疗失败的晚期恶性实体瘤患者中的安全性和耐受性，并探索注射用莱古比星的最大耐受剂量（MTD），确定II期临床试验推荐剂量（RP2D） Objectives of Study：
The objective is to evaluate the safety and tolerability of single-agent Legubicin for Injection in patients with advanced malignant solid tumors who have failed standard therapy, and to determine the maximum tolerated dose (MTD) of leugubicin, establishing the recommended phase 2 dose (RP2D)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.年龄18-75周岁（含两端），性别不限。
2.组织学或细胞学确认的晚期恶性实体肿瘤患者（剂量扩展阶段优先选入肺癌等），经标准治疗失败，或无标准治疗方案，或现阶段不适用标准治疗。
3.根据RECIST 1.1版，至少有一个可评估的肿瘤病灶。
4.ECOG体力评分0-1分。
5.预计生存时间3个月以上。
6.有充分的器官功能：
（1）血液系统（14天内未接受过输血或造血刺激因子治疗）
1）中性粒细胞绝对值（ANC）>=1.5×10^9/L
2）血小板（PLT）>=75×10^9/L
3）血红蛋白（Hb）>=90g/L
（2）肝功能
1）总胆红素（TBIL）<=1.5×ULN
2）丙氨酸氨基转移酶（ALT）<=3×ULN；
3）肝转移或肝癌患者：<=5×ULN
4）天门冬氨酸氨基转移酶（AST）<=3×ULN；
5）肝转移或肝癌患者：<=5×ULN
（3）肾功能
1）肌酐清除率（Ccr）＞50ml/min（根据Cockcroft-Gault公式计算）
（4）凝血功能
1）活化部分凝血活酶时间（APTT）<=1.5×ULN
2）国际标准化比值（INR）<=1.5×ULN
（5）心脏动能
1）12导联心电图QTc间期<=480ms
2）超声心动图左室射血分数（LVEF）>=55%
（6）HCC患者肝功能分级
1）Child-Pugh评分<=7分
7.有生育能力的合格患者（男性和女性）必须同意在试验期间和末次用药后至少3个月内与其伴侣一起使用可靠的避孕方法（激素或屏障法或禁欲）；育龄期的女性患者在入选前7天内的血或尿妊娠试验必须为阴性。
8.受试者须在试验前对本研究知情同意，并自愿签署书面的知情同意书。Inclusion criteria
1. Age: 18 - 75 years old (inclusive of both ends), gender not restricted.
2. Patients with advanced malignant solid tumors confirmed by histology or cytology (priority for lung cancer and other types in the dose expansion stage), who have failed standard treatment, or have no standard treatment options, or whose current standard treatment is not applicable.
3. According to RECIST 1.1 version, at least one evaluable tumor lesion.
4. ECOG physical performance score: 0 - 1.
5. Expected survival time: more than 3 months.
6. Adequate organ function:
(1) Hematological system (no blood transfusion or hematopoietic stimulating factor treatment within 14 days)
1) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L
2) Platelets (PLT) >= 75 × 10^9/L
3) Hemoglobin (Hb) >= 90 g/L
(2) Liver function
1) Total bilirubin (TBIL) <= 1.5 × ULN
2) Alanine aminotransferase (ALT) <= 3 × ULN;
3) For patients with liver metastasis or liver cancer: <= 5 × ULN
4) Aspartate aminotransferase (AST) <= 3 × ULN;
5) For patients with liver metastasis or liver cancer: <= 5 × ULN
(3) Renal function
1) Creatinine clearance rate (Ccr) > 50 ml/min (calculated according to the Cockcroft-Gault formula)
(4) Coagulation function
1) Activated partial thromboplastin time (APTT) <= 1.5 × ULN
2) International normalized ratio (INR) <= 1.5 × ULN
(5) Cardiac kinetic energy
1) 12-lead electrocardiogram QTc interval <= 480 ms
2) Echocardiography left ventricular ejection fraction (LVEF) >= 55%
(6) Liver function classification for HCC patients
1) Child-Pugh score <= 7 points
7. Qualified patients with reproductive capacity (both male and female) must agree to use reliable contraceptive methods (hormonal or barrier method or abstinence) with their partners during the trial period and for at least 3 months after the last medication; for female patients of childbearing age, the blood or urine pregnancy test within 7 days before enrollment must be negative.
8. Participants must be informed and consent to this study before the trial, and voluntarily sign a written informed consent form.排除标准：
1.首次给药前4周内接受过化疗，前4周内接受过放疗、靶向治疗、生物治疗、内分泌治疗、免疫治疗等抗肿瘤治疗，除外以下几项：
（1）亚硝基脲或丝裂霉素C为首次使用研究药物前6周内；
（2）口服氟尿嘧啶类和小分子靶向药物为首次使用研究药物前2周或药物的5个半衰期内（以时间长的为准）；
（3）有抗肿瘤适应症的中药为首次使用研究药物前2周内；
（4）曲妥珠单抗为首次使用研究药物前6个月内。
2.既往曾接受过多柔比星或其他蒽环类药物治疗
3,首次给药前4周内接受过其它未上市的临床研究药物或治疗。
4.首次给药前4周内接受过主要脏器外科手术（不包括穿刺活检）或出现过显著外伤，或需要在试验期间接受择期手术。
5.首次给药前14天内接受过全身使用的糖皮质激素（强的松＞10mg/天或等价剂量的同类药物）或其他免疫抑制剂治疗；
除外以下情况：使用局部、眼部、关节腔内、鼻内和吸入型糖皮质激素治疗；短期使用糖皮质激素进行预防治疗（例如预防造影剂过敏）。
6.既往抗肿瘤治疗的不良反应尚未恢复到CTCAE 5.0等级评价<=1级（脱发等研究者判断无安全风险的毒性除外）。
7.具有临床症状的中枢神经系统转移或脑膜转移，或有其他证据表明患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。
8.首次给药前1周内存在活动性感染，且需要系统性抗感染治疗者（不适用于肝炎病毒感染，参照第9条）。
9.活动性乙型肝炎（乙型肝炎病毒滴度＞10^3拷贝/ml或200IU/ml）：丙型肝炎病毒感染（HCV-RNA高于检测下限）：允许除干扰素以外的预防性抗病毒治疗。对于HCC患者，乙型肝炎病毒滴度＞10^4拷贝/ml或2000IU/ml方排除。
10.有免疫缺陷病史，包括HIV抗体检测阳性。
11.有严重的心脑血管疾病史，包括但不限于：
(1)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；
(2)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；
(3)美国纽约心脏病协会（NYHA）心功能分级≥II级或左室射血分数（LVEF）＜50％，或有其他研究者判断具有高风险的结构性心脏病；
(4)临床无法控制的高血压；
(5)任何增加QTc延长风险或心律失常风险的因素，如心衰、低钾血症、先天性长QT综合症、长QT综合症家族史或一级亲属中有小于40岁发生无法解释的猝死、使用任何已知可延长QT间期的伴随药物（详见附录8）。
12.临床无法控制的第三间隙积液，经研究者判断不适合入组。
13.已知有酒精或药物依赖。
14.已知有酒精过敏史。
15.精神障碍者或依从性差者。
16.妊娠期或哺乳期女性。
17.研究者认为受试者存在其他严重的系统性疾病史、或其他原因而不适合参加本临床研究。Exclusion criteria：
1. Within 4 weeks prior to the first administration, the subject had received chemotherapy, radiotherapy, targeted therapy, biological therapy, endocrine therapy, immunotherapy, or other anti-tumor treatments. Exclusions include the following:
(1) Nitrosoureas or mitomycin C were used within 6 weeks prior to the first administration of the study drug;
(2) Oral fluorouracil and small molecule targeted drugs were used within 2 weeks of the first administration of the study drug or within 5 half-lives of the drug (whichever is longer);
(3) Traditional Chinese medicine with anti-tumor indications was used within 2 weeks of the first administration of the study drug;
(4) Trastuzumab was used within 6 months of the first administration of the study drug.
2. The subject had previously received multiple doxorubicin or other anthracycline drugs.
3. Within 4 weeks prior to the first administration, the subject had received other off-label clinical research drugs or treatments.
4. Within 4 weeks prior to the first administration, the subject had undergone major organ surgery (excluding biopsy) or had suffered significant trauma, or required elective surgery during the trial.
5. Within 14 days prior to the first administration, the subject had received systemic glucocorticoids (prednisone > 10mg/day or equivalent doses of similar drugs) or other immunosuppressant treatments;
Exclusions include: local, ocular, joint cavity, nasal, and inhalation glucocorticoid treatments; short-term use of glucocorticoids for prophylactic treatment (such as for preventing contrast agent allergy).
6. The adverse reactions from previous anti-tumor treatments have not yet recovered to a CTCAE 5.0 grade evaluation <= 1 (excluding toxicities such as hair loss judged by the investigator to be without safety risks).
7. Has clinical symptoms of central nervous system metastasis or meningeal metastasis, or has other evidence indicating that the patient's central nervous system metastasis or meningeal metastatic lesions have not been controlled, and the investigator judges that the subject is not suitable for enrollment.
8. Within 1 week prior to the first administration, the subject had active infection and required systemic anti-infection treatment (not applicable to hepatitis virus infection, refer to item 9).
9. Active hepatitis B (hepatitis B virus titer > 10^3 copies/ml or 200IU/ml): hepatitis C infection (HCV-RNA above the detection limit): Permitted preventive antiviral treatment except interferon. For HCC patients, hepatitis B virus titer > 10^4 copies/ml or 2000IU/ml are excluded.
10. Have immune deficiency disease history, including positive HIV antibody test.
11. Have a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
(1) Severe cardiac rhythm or conduction abnormalities, such as clinically intervened ventricular arrhythmias, II-III degree atrioventricular block, etc.;
(2) Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or above cardiovascular events within 6 months of the first administration;
(3) American Heart Association (NYHA) cardiac function classification ≥ II grade or left ventricular ejection fraction (LVEF) < 50%, or other factors judged by the investigator to have high risk of structural heart disease;
(4) Uncontrolled hypertension;
(5) Any factor that increases the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, long QT syndrome family history or a first-degree relative with an unexpected sudden death under 40 years old, using any known drugs that prolong the QT interval (see Appendix 8).
12. Have uncontrollable third space effusion, and the subject is judged by the investigator not suitable for enrollment.
13. Known alcohol or drug dependence.
14. Known history of alcohol allergy.
15. Mentally ill or with poor compliance.
16. Pregnant or lactating women.
17. The investigator considers that the subject has other serious systemic disease history or other reasons that make them unsuitable to participate in this clinical study.研究实施时间：
Study execute time：
从
From
2020-01-10 00:00:00至
To
2027-01-10 00:00:00
征募观察对象时间：
Recruiting time：
从
From
2020-05-07 00:00:00
至
To
2027-01-10 00:00:00干预措施：
Interventions：
组别：
试验组
样本量：
30
Group：
Experimental group
Sample size：
干预措施：
注射用莱古比星的起始给药剂量定为20mg/m^2，预设的最高递增剂量为200mg/m^2，暂定5个剂量组。本阶段总体设计采用加速滴定结合传统3+3剂量递增方法
干预措施代码：
Intervention：
The initial dosage of legobex for injection is set at 20mg/m^2, with the preset maximum incremental dose being 200mg/m^2. Five dose groups are tentatively planned. The overall design of this stage adopts accelerated titration combined with the traditional 3+3 dose escalation method.
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)：
同济大学附属东方医院
单位级别：
三甲
Institution
hospital：
The East Hospital Affiliated to Tongji University
Level of the institution：
Tertiary A测量指标：
Outcomes：
指标中文名：
MTD/RP2D
指标类型：
主要指标
Outcome：
MTD/RP2D
Type：
Primary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
DLT发生的情况和例数
指标类型：
主要指标
Outcome：
Incidence & Number of DLTs
Type：
Primary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
AE和SAE发生的情况和频率（根据NCI CTCAE5.0）
指标类型：
主要指标
Outcome：
Incidence & Frequency of AEs and SAEs (NCI CTCAE 5.0)
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：包括但不限于AUC、CL、Cmin、Cmax、T1/2等
指标类型：
次要指标
Outcome：
Pharmacokinetic (PK) parameters: including but not limited to AUC, CL, Cmin, Cmax, T?/?, et al.
Type：
Secondary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
疗效：根据RECIST1.1标准确定的客观缓解率（ORR）、疾病控制率（DCR）、和无进展生存期（PFS）
指标类型：
次要指标
Outcome：
Efficacy: Objective Response Rate (ORR), Disease Control Rate (DCR) and Progression-Free Survival (PFS) assessed per RECIST Version 1.1 criteria.
Type：
Secondary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
外周血淋巴细胞亚群CD3+、CD4+和CD8+T细胞亚群百分比；癌痛程度（以数字分级法NRS评估）；甲胎蛋白（AFP,仅HCC患者）；β胶原降解产物（β-CTX）（仅肿瘤骨转移患者）
指标类型：
次要指标
Outcome：
Percentage of CD3+, CD4+ and CD8+ T-cell subsets in peripheral blood lymphocytes; Severity of cancer pain (assessed by the Numerical Rating Scale [NRS]); Alpha-fetoprotein (AFP, for HCC patients only); Beta C-terminal telopeptide of type I collagen (β-CTX) (for patients with tumor bone metastasis only)
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：
上肢静脉
Sample Name：
Blood
Tissue：
Venae superioris
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：
正在进行
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
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）：
研究结束后半年内，通过ResMan(www.medresman.org.cn)方式共享The way of sharing IPD”(include metadata and
protocol,
If use web-based public database, please provide
the
url)：
Within six months after the completion of the research, the results will be shared via ResMan (www.medresman.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：
CRF;EDCData collection and Management (A
standard data collection and management system
include a CRF and an electronic data capture：
CRF;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：
2026-04-09 11:54:58
