ChiCTR2600119925 版本V1.0 版本创建时间2026/03/05 16:11:31 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：

ChiCTR2600119925 

最近更新日期：

Date of Last Refreshed on：

2026-03-05 16:11:26 

注册时间：

Date of Registration：

2026-03-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评价ZL-85FA片治疗晚期实体瘤的安全性、耐受性、药代动力学和初步疗效的开放性、多中心Ⅰ/IIa期临床研究

Public title：

An open-label, multicenter phase I/IIa clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZL-85FA tablets in treating advanced solid tumors

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项评价ZL-85FA片治疗晚期实体瘤的安全性、耐受性、药代动力学和初步疗效的开放性、多中心Ⅰ/IIa期临床研究

Scientific title：

An open-label, multicenter phase I/IIa clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZL-85FA tablets in treating 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：

王方梅 

研究负责人：

孙倍成/周焕 

Applicant：

Wang Fangmei  

Study leader：

Sun Beicheng/Zhou Huan 

申请注册联系人电话：

Applicant telephone：

+86 138 0808 6495

研究负责人电话：

Study leader's telephone：

+86 137 7641 3940

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：

fangmei.wang@zenitar.cn

研究负责人电子邮件：

Study leader's E-mail：

sunbc0207@163.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：

四川省成都市高新区和民街16号

研究负责人通讯地址：

安徽省合肥市绩溪路218号

Applicant address：

No. 16, Hemin Street, High-tech Zone, Chengdu City, Sichuan Province

Study leader's address：

No. 218, Jixi Road, Hefei City, Anhui Province

申请注册联系人邮政编码：

Applicant postcode：

610200

研究负责人邮政编码：

Study leader's postcode：

230022

申请人所在单位：

成都赜灵生物医药科技有限公司

Applicant's institution：

Chengdu Zenitar Biomedical Technology Co. Ltd

研究负责人所在单位：

安徽医科大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Anhui Medical University

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：

安医一附院伦审-PJ2025-16-08

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：

安徽医科大学第一附属医院临床医学研究伦理委员会

Name of the ethic committee：

Clinical Medical Research Ethics Committee of the First Affiliated Hospital of Anhui Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-12-18 00:00:00

伦理委员会联系人：

葛颖

Contact Name of the ethic committee：

Ge Ying

伦理委员会联系地址：

安徽省合肥市绩溪路218号

Contact Address of the ethic committee：

No. 218, Jixi Road, Hefei City, Anhui Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 551 6292 2017

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：

安徽医科大学第一附属医院

Primary sponsor：

The First Affiliated Hospital Of Anhui Medical University

研究实施负责（组长）单位地址：

安徽省合肥市绩溪路218号

Primary sponsor's address：

No. 218, Jixi Road, Hefei City, Anhui Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

四川省

市(区县)：

Country：

China

Province：

Sichuan

City：

单位(医院)：

成都赜灵生物医药科技有限公司

具体地址：

中国（四川）成都市高新区和民街16号前沿医学中心E3栋9楼

Institution
hospital：

Chengdu Zenitar Biomedical Technology Co. Ltd

Address：

9F, Building 3, No. 16 Hemin Street, Chengdu High-tech Zone, China (Sichuan) Pilot Free

经费或物资来源：

自筹

Source(s) of funding：

Self-raised

Target disease：

Advanced 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+II期 

Study phase：

1-2

研究设计：

单臂 

Study design：

Single arm 

研究目的：

旨在评价ZL-85FA片治疗晚期实体瘤患者中的安全性、耐受性、药代动力学特征、初步疗效和相应生物标记物与疗效相关性。  

Objectives of Study：

The aim is to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and correlation between corresponding biomarkers and efficacy of ZL-85FA tablets in the treatment of advanced solid tumor patients.

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.自愿加入本研究，签署知情同意书，依从性好，能配合随访； 2.年龄：>=18岁，且<=75岁（含边界值，以签署知情同意当日计算），性别不限； 3.经病理组织学或细胞学证实，经标准治疗失败，或无标准治疗方案，或现阶段不适合标准治疗的局部晚期或转移性实体瘤； 4.剂量递增阶段，至少有一个可评估病灶；剂量扩展阶段，根据RECIST1.1标准至少有一处可测量病灶； 5.ECOG <=1分； 6.预期生存期>=12周； 7.足够的器官功能； 8.既往抗癌治疗或外科手术的所有急性毒性反应缓解至基线严重程度或NCI-CTCAE版本5.0<=1级（脱发或研究者认为对患者无安全风险的其他毒性除外）； 9.育龄期女性和男性应同意在研究期间和研究结束后6个月内需采取有效避孕措施（激素或屏障法或禁欲）；育龄期的女性患者在给药前的7天内血清或尿妊娠试验阴性，且必须为非哺乳期患者

Inclusion criteria

1. Voluntary participation in this study, signing the informed consent form, good compliance, and able to cooperate with follow-up; 2. Age: >= 18 years old and <= 75 years old (including the boundary values, calculated from the date of signing the informed consent form); gender not restricted; 3. Confirmed by pathological histology or cytology, failed standard treatment, or no standard treatment plan, or not suitable for standard treatment at the current stage of locally advanced or metastatic solid tumors; 4. In the dose escalation stage, at least one evaluable lesion; in the dose expansion stage, according to the RECIST 1.1 standard, at least one measurable lesion; 5. ECOG <= 1 point; 6. Expected survival period >= 12 weeks; 7. Adequate organ function; 8. All acute toxic reactions from previous anti-cancer treatment or surgical procedures have been relieved to the baseline severity or NCI-CTCAE version 5.0 <= 1 grade (excluding hair loss or other toxicities considered safe by the investigator that do not pose a risk to the patient); 9. Married women and men should agree to take effective contraceptive measures during the study period and within 6 months after the study ends (hormonal or barrier methods or abstinence); for married female patients, the serum or urine pregnancy test should be negative within 7 days before administration, and must be non-lactating patients.

排除标准：

1.已知对研究药物或其任一辅料（乳糖、微晶纤维素、低取代羟丙纤维素、山嵛酸甘油酯、羟丙甲纤维素、薄膜包衣预混剂（胃溶型））严重过敏； 2.目前或既往患有其他恶性肿瘤（经充分治疗的皮肤基底细胞癌或鳞状细胞癌、宫颈原位癌除外），除非进行了根治性治疗且有近5年内无复发转移的证据； 3.有症状的中枢神经系统（CNS）转移或在首次使用研究药物前2周内需要类固醇治疗、无症状的CNS转移者。患有癌性脑膜炎或软脑膜扩散的受试者； 4.在首次给药前4周内接受过最后一次全身性抗肿瘤治疗（化疗、靶向治疗、免疫治疗、生物制剂治疗等），丝裂霉素或亚硝胺为6周内，小分子靶向药物为研究药物首次给药前2周或已知药物的5个半衰期内（以时间长的为准）；局部姑息性放疗在首次使用研究药物前2周内；内分泌治疗末次给药为研究药物首次给药前2周内（转移性去势抵抗性前列腺癌患者必要的药物去势治疗除外）；研究药物首次给药前2周内曾接受具有抗肿瘤适应症的中草药或中成药； 5.首次给药前4周内有严重感染者，或前2周内出现活动性感染需要口服或静脉接受抗生素治疗者；伴有活动性肺结核者，首次用药前经过充分治疗并已停止抗结核治疗>=3个月者可以入组 ； 6.在首次使用研究药物前2周内接受输血、重组人血小板生成素、重组人白介素-11、促红细胞生成素、粒细胞集落刺激因子等治疗； 7.首次给药前14天内接受过全身使用的皮质类固醇（强的松＞10 mg/天或等价剂量的同类药物，连续使用时间超过4天）或其他免疫抑制剂治疗的患者；除外以下情况：使用局部、眼部、关节腔内、鼻内和吸入型皮质类固醇治疗，短期使用皮质类固醇进行预防治疗，如使用造影剂。 8.有无法控制的或重要的心脑血管疾病，包括： （1）在首次用药前 6 个月内出现纽约心脏病协会（NYHA）II级以上充血性心力衰竭、不稳定型心绞痛、心肌梗死，或者在筛选时存在需要治疗的心律失常、左室射血分数（LVEF）＜50%； （2）原发性心肌病（如扩张型心肌病、肥厚型心肌病、致心律失常性右室心肌病、限制型心肌病、未定型心肌病）； （3）筛选期血压控制不充分：收缩压>=140 mmHg或舒张压>=90 mmHg； （4）其他经研究者判断不适宜入组的心脑血管疾病。 9.无法控制的电解质紊乱，可能会影响延长QTc药物的作用（如低钙血症<1.0 mmol/L、低钾血症<正常值下限、低镁血症<0.5 mmol/L），但允许进行干预治疗后进行复测； 10.首次给药前4周内进行过需要全身麻醉的大手术或没有从其他临床试验中退出者；入组前2周内，进行过需要局部麻醉/硬膜外麻醉的手术、且患者尚未恢复（除外组织活检）； 11.有临床意义的以下活动性感染，包括乙肝（HBV）、丙肝（HCV）。活动性乙型肝炎定义为：HBsAg阳性或HBcAb阳性且HBV-DNA高于检测下限（即各研究中心检验科正常值上限）的受试者，如经过抗病毒治疗后达到HBV-DNA阴性，且在首次给药前至少接受2周抗病毒药物治疗，研究期间愿意持续接受抗乙肝病毒治疗的允许入组，活动性丙型肝炎定义为HCV抗体阳性且HCV-RNA高于检测下限（正常值上限）。梅毒螺旋体抗体（TP-Ab）阳性且梅毒非特异性抗体滴度（RPR）阳性； 12.有免疫缺陷病史，包括人类免疫缺陷病毒（HIV）抗体检测阳性，或患有其他获得性、先天性免疫缺陷疾病，或有器官移植史； 13.吞咽困难，慢性腹泻或口服吸收障碍的患者； 14.有出血倾向的患者； 15.入组前4周内，参加过其他干预性临床试验； 16.其他严重急性或慢性医学或精神病症或实验室检查异常，可能增加参与研究的风险或增加研究药物给药相关的风险，或干扰研究结果，以及研究者认为患者不适合参与本研究的其他情况。

Exclusion criteria：

1. Known severe allergy to the investigational drug or any of its excipients (lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, caprylic glycerol ester, hydroxypropyl methylcellulose, film-coated pre-mix (gastric-release type)), except for skin basal cell carcinoma or squamous cell carcinoma that has been fully treated, and cervical carcinoma in situ, provided that radical treatment has been performed and there is no recurrence or metastasis within the past 5 years; 2. Currently or previously have other malignant tumors (except for skin basal cell carcinoma or squamous cell carcinoma that has been fully treated), unless radical treatment has been performed and there is no recurrence or metastasis within the past 5 years; 3. Symptomatic central nervous system (CNS) metastasis or requiring steroid treatment within 2 weeks before the first use of the investigational drug, and asymptomatic CNS metastasis. Patients with carcinomatous meningitis or soft meningeal spread; 4. Within 4 weeks before the first administration, received the last systemic anti-tumor treatment (chemotherapy, targeted therapy, immunotherapy, biological agent therapy, etc.), mitomycin or nitrosamine within 6 weeks, small molecule targeted drugs within 2 weeks before the first administration of the investigational drug or within 5 half-lives of the known drug (whichever is longer), local palliative radiotherapy within 2 weeks before the first use of the investigational drug; endocrine therapy last administration within 2 weeks before the first administration of the investigational drug (except for necessary drug castration therapy for metastatic castration-resistant prostate cancer patients); the first administration of the investigational drug within 2 weeks before the patient received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications; 5. Within 4 weeks before the first administration had a severe infection, or had active infection requiring oral or intravenous antibiotic treatment within 2 weeks before the first administration; patients with active pulmonary tuberculosis, those who have undergone adequate treatment and have stopped anti-tuberculosis treatment for >= 3 months before the first administration can be enrolled; 6. Within 2 weeks before the first use of the investigational drug received treatment such as blood transfusion, recombinant human thrombopoietin, recombinant human interleukin-11, erythropoietin, granulocyte colony-stimulating factor, etc.; 7. Within 14 days before the first administration received systemic corticosteroids (prednisone > 10 mg/day or equivalent doses of similar drugs, continuous use for more than 4 days) or other immunosuppressant treatments; except for the following situations: treatment with local, ocular, joint cavity, nasal and inhalation corticosteroids, short-term use of corticosteroids for preventive treatment, such as the use of contrast agents. 8. Uncontrolled or significant cardiovascular and cerebrovascular diseases, including: (1) Within 6 months before the first administration, developed NYHA grade II or above congestive heart failure, unstable angina pectoris, myocardial infarction, or had a need for treatment of arrhythmia at the screening, or left ventricular ejection fraction (LVEF) < 50%; (2) Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, undetermined cardiomyopathy); (3) Insufficient blood pressure control during the screening: systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg; (4) Other cardiovascular and cerebrovascular diseases judged by the investigator to be unsuitable for enrollment. 9. Uncontrolled electrolyte disorders, which may affect the action of drugs that prolong QTc (such as hypocalcemia < 1.0 mmol/L, hypokalemia < lower limit of normal values, hypomagnesemia < 0.5 mmol/L), but allow for retesting after intervention treatment; 10. Within 4 weeks before the first administration had undergone major surgeries requiring general anesthesia or did not withdraw from other clinical trials; patients who underwent surgery requiring local anesthesia/electroanesthetic anesthesia within 2 weeks before the first administration and have not recovered (except for tissue biopsy); 11. Clinically significant active infections, including hepatitis B (HBV) and hepatitis C (HCV). Active hepatitis B is defined as: subjects who are positive for HBsAg or HBcAb and have HBV-DNA levels above the detection limit (i.e., the upper limit of the normal range in each research center's laboratory), and who achieve HBV-DNA negativity after antiviral treatment and have received at least 2 weeks of antiviral medication before the first administration, and who are willing to continue antiviral treatment during the study period are allowed to be enrolled. Active hepatitis C is defined as: subjects who are positive for HCV antibodies and have HCV-RNA levels above the detection limit (upper limit of the normal range). Positive for Treponema pallidum antibody (TP-Ab) and positive for non-specific antibody titers of syphilis (RPR); 12. History of immunodeficiency, including positive human immunodeficiency virus (HIV) antibody test results, or having other acquired or congenital immune deficiency diseases, or a history of organ transplantation; 13. Patients with dysphagia, chronic diarrhea or oral absorption disorders; 14. Patients with bleeding tendencies; 15. Participants who have participated in other interventional clinical trials within 4 weeks before enrollment; 16. Other severe acute or chronic medical or mental disorders or laboratory test abnormalities that may increase the risk of participating in the study or increase the risk of drug administration related to the study drugs, or interfere with the study results, and other situations that the investigator considers as not suitable for participating in this study.

研究实施时间：

Study execute time：

从 From 2026-01-30 00:00:00至 To 2028-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-03-06 00:00:00 至 To 2027-12-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

72

Group：

Experimental group

Sample size：

干预措施：

ZL-85FA片干预治疗

干预措施代码：

Intervention：

ZL-85FA Tablets Intervention Therapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

  

Country：

China 

Province：

Anhui 

City：

 

单位(医院)：

安徽医科大学第一附属医院 

单位级别：

三甲 

Institution
hospital：

The First Affiliated Hospital Of Anhui Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

客观缓解率

指标类型：

主要指标

Outcome：

Objective remission rate

Type：

Primary 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

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

起效时间

指标类型：

次要指标

Outcome：

Time to response

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

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

无进展生存期

指标类型：

次要指标

Outcome：

Progression free survival

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

总生存期

指标类型：

次要指标

Outcome：

Overall survival

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：

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:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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：

CRF;EDC

Data 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：

有/Yes

注册人：

Name of Registration：

  2026-03-05 16:11:26