ChiCTR2400081035 版本V1.1 版本创建时间2024/02/20 17:53:15 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：

 ChiCTR2400081035 

最近更新日期：

Date of Last Refreshed on：

 2024-02-20 17:53:03 

注册时间：

Date of Registration：

 2024-02-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项在晚期实体瘤患者中评估 ABP1019A 片的安全性、耐受性、药代动 力学特征和初步疗效的剂量递增及扩展队列的开放性 I/II 期临床研究

Public title：

An Open Phase I/II Dose Escalation and Expansion Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Initial Efficacy of ABP1019A Tablets in Patients with Advanced Solid Tumors

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项在晚期实体瘤患者中评估 ABP1019A 片的安全性、耐受性、药代动 力学特征和初步疗效的剂量递增及扩展队列的开放性 I/II 期临床研究

Scientific title：

An Open Phase I/II Dose Escalation and Expansion Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Initial Efficacy of ABP1019A Tablets in Patients with 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：

王海平 

研究负责人：

石远凯 

Applicant：

Haiping Wang 

Study leader：

Shi Yuankai  

申请注册联系人电话：

Applicant telephone：

 +86 133 8158 8683

研究负责人电话：

Study leader's
telephone：

+86 137 0125 1865

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：

 hpwang@zannan.com

研究负责人电子邮件：

Study leader's E-mail：

 syuankaipumc@126.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：

上海市闵行区光中路133弄99号

研究负责人通讯地址：

北京市朝阳区潘家园南里17号

Applicant address：

99 Lane133 Guangzhong RD, Shanghai, P.R. China

Study leader's address：

No.17 Panjiayuan Nanli, Chaoyang District,P.R. China

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：

 100021

申请人所在单位：

上海爱博医药科技有限公司

Applicant's institution：

Shanghai AB PharmaTech Ltd.

研究负责人所在单位：

中国医学科学院肿瘤医院

Affiliation of the Leader：

Cancer Hospital Chinese Academy of Medical Sciences

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：

 24/009-4289

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：

中国医学科学院肿瘤医院伦理委员会

Name of the ethic committee：

Ethics Committee of Cancer Hospital Chinese Academy of Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-02-04 00:00:00

伦理委员会联系人：

吴大维

Contact Name of the ethic committee：

Dawei Wu

伦理委员会联系地址：

北京市朝阳区潘家园南里17号

Contact Address of the ethic committee：

No.17 Panjiayuan Nanli, Chaoyang District,P.R. China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 8778 8495

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：

中国医学科学院肿瘤医院

Primary sponsor：

Cancer Hospital Chinese Academy of Medical Sciences

研究实施负责（组长）单位地址：

北京市朝阳区潘家园南里17号

Primary sponsor's address：

No.17 Panjiayuan Nanli, Chaoyang District,P.R. 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)：

上海市

市(区县)：

上海市

Country：

China

Province：

Shanghai

City：

Shanghai

单位(医院)：

上海爱博医药科技有限公司

具体地址：

上海市闵行区光中路133弄99

Institution
hospital：

Shanghai AB PharmaTech Ltd.

Address：

99 Lane133 Guangzhong RD, Shanghai, P.R. China

经费或物资来源：

上海爱博医药科技有限公司

Source(s) of funding：

Shanghai AB PharmaTech Ltd.

研究疾病：

晚期实体瘤  

Target disease：

Advanced 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：

（一）I 期研究目的 1 主要研究目的 评估 ABP1019A 片在晚期实体瘤患者中的安全性和耐受性；确定后继临床试验推荐剂量（RP2D）以及给药方案。 2 次要研究目的 研究 ABP1019A 片单次和多次给药在晚期实体瘤患者中的药代动 力学（PK）特征。 初步评估 ABP1019A 片的心脏安全性，包括校正 QT 间期（QTc） 延长的可能性，并评估 PK/QTc 关系。 初步评估 ABP1019A 片治疗晚期实体瘤的有效性。 （二）II 期研究目的 1 主要研究目的 初步评估 ABP1019A 片在目标晚期实体瘤患者中的有效性。 2 次要研究目的 评估 ABP1019A 片在目标晚期实体瘤患者中的安全性。  

Objectives of Study：

(1)Phase I Primary Objective: To evaluate the safety and tolerability of ABP1019A Tablets in patients with advanced solid tumors; to determine the recommended dose (RP2D) for a follow-on clinical trial and the dosing regimen. Secondary Objective: To study the pharmacokinetic (PK) profile of ABP1019A Tablet in patients with advanced solid tumors after single and multiple doses. kinetics (PK) profile. Preliminarily assess the cardiac safety of ABP1019A tablets, including the potential for corrected QT interval (QTc) prolongation, and assess PK/prolongation. (QTc) prolongation and to assess the PK/QTc relationship. Preliminary evaluation of the efficacy of ABP1019A tablets in the treatment of advanced solid tumors. (2)Phase II Primary Objective: Preliminary assessment of the effectiveness of ABP1019A tablets in patients with targeted advanced solid tumors. Secondary Objective: To evaluate the safety of ABP1019A Tablet in patients with targeted advanced solid tumors.

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)自愿签署知情同意书，并遵循方案要求； (2)18岁≤年龄≤65岁，男女不限； (3)预期生存期≥12周； (4)ECOG≤1分（除脑胶质瘤外的其它实体瘤患者），或KPS≥60（脑胶质瘤患者）； (5)I期研究：标准治疗下仍发生疾病进展、不耐受标准治疗或缺乏有效标准治疗，且病理学或细胞学确诊的晚期实体瘤患者；至少具有1个符合实体瘤疗效评估标准（RECIST）v1.1标准的可测量病灶； II期研究：标准治疗失败或不能耐受且经病理学或细胞学确诊的脑胶质瘤、胰腺癌、胃癌、卵巢癌和膀胱上皮癌或I期试验中发现的其它敏感瘤种的患者；至少具有1个符合RECIST v1.1标准的可测量病灶（脑胶质瘤按RANO 标准存在至少一处颅内可测量的肿瘤病灶）； (6)首次给药前已经从以往末次治疗的毒性效应中恢复（CTCAE≤1级，除脱发、色素沉着等特殊情况外），此外研究者判断相应AE不具有安全性风险者； (7)收缩压≤140 mmHg，舒张压≤90 mmHg，且首次给药前7天内降压药物及使用剂量无变化。 (8)器官和骨髓功能水平必须符合下列要求： ?骨髓：中性粒细胞计数绝对值（ANC）≥1.5×10^9/L，血小板计数≥100×10^9/L，血红蛋白≥90 g/L，且首次给药前14天内未输血小板或红细胞，且首次给药前14天内未接受过输血或生物反应调节剂（如促粒细胞生长因子、促红细胞生长因子、白介素-11等）治疗； ?肝功能：无肝硬化病史（失代偿性肝硬化Child-Pugh B、C级）。无肝转移患者要求血清总胆红素（TBIL）≤1.5×正常上限（ULN）（非结合高胆红素血症或吉尔伯特综合征除外），丙氨酸氨基转移酶（ALT）和天门冬氨酸氨基转移酶（AST）≤3×ULN。有肝转移患者要求TBIL≤2.5×ULN，ALT和AST≤5×ULN； ?肾功能：血清肌酐≤1.5×ULN，或肌酐清除率>50 mL/min（Cockcorft-Gault公式）；尿蛋白定性≤1+；如果尿蛋白定性≥2+，则需进行24h尿蛋白定量检查且24小时内尿液中的蛋白含量<1g；研究者根据检查结果进行入组判断； ?凝血功能：凝血酶原时间（PT）≤1.5倍ULN，国际标准化比值（INR）≤1.5×ULN，且活化部分凝血活酶时间（APTT）≤1.5×ULN。 （9）育龄期女性受试者必须在开始研究用药前3天内进行血清妊娠试验，且结果为阴性，并且愿意在研究期间和末次给予研究药物后6个月内采用一种经医学认可的高效避孕措施（如：宫内节育器、避孕药或避孕套）；对于伴侣为育龄期女性的男性受试者，应同意在研究期间和末次研究给药后6个月内采用有效的方法避孕。

Inclusion criteria

(1) Voluntarily sign an informed consent form and comply with the requirements of the plan; (2) 18 years old ≤ age ≤ 65 years old, no gender limit; (3) Expected survival time ≥ 12 weeks; (4) ECOG ≤ 1 point (for patients with solid tumors other than gliomas), or KPS ≥ 60 point (for patients with gliomas); (5) Phase I study: Patients with advanced solid tumors who still experience disease progression under standard treatment, are intolerant to standard treatment, or lack effective standard treatment, and are confirmed by pathology or cytology; At least one measurable lesion that meets the criteria for evaluating the efficacy of solid tumors (RECIST) v1.1; Phase II study: patients with glioma, pancreatic cancer, gastric cancer, ovarian cancer, bladder epithelial cancer or other sensitive tumors found in phase I test who failed or could not tolerate standard treatment and were confirmed by pathology or cytology; At least one measurable lesion that meets the RECIST v1.1 standard (there is at least one intracranial measurable tumor lesion in gliomas according to the RANO standard); (6) Prior to the first administration, the patient had already recovered from the toxic effects of previous treatments (CTCAE ≤ 1 level, except for special cases such as hair loss and pigmentation). In addition, the researcher determined that the corresponding AE did not pose a safety risk; (7) Systolic blood pressure ≤ 140 mmHg, diastolic blood pressure ≤ 90 mmHg, and there is no change in the antihypertensive medication and dosage used within 7 days before the first administration. (8) Organ and bone marrow functional levels must meet the following requirements: Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 90 g/L, and no platelet or red blood cell transfusion within 14 days before the first administration, and no blood transfusion or biological response regulator treatment (such as granulocyte growth factor, erythropoietin, interleukin-11, etc.) has been received within 14 days before the first administration; Liver function: No history of cirrhosis (decompensated cirrhosis Child Pugh B, C grade). Patients without liver metastasis require serum total bilirubin (TBIL) ≤ 1.5 × Upper limit of normal (ULN) (excluding unconjugated hyperbilirubinemia or Gilbert syndrome), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN. Patients with liver metastasis require TBIL ≤ 2.5 × ULN, ALT, and AST ≤ 5 × ULN; Renal function: serum creatinine ≤ 1.5 × ULN, or creatinine clearance rate>50 mL/min (Cockcorft Gault formula); Qualitative analysis of urine protein ≤ 1+; If the qualitative urine protein is ≥ 2+, a 24-hour urine protein quantitative test is required, and the protein content in the urine within 24 hours is less than 1g; Researchers make inclusion judgments based on the examination results; Coagulation function: prothrombin time (PT) ≤ 1.5 times ULN, international standardized ratio (INR) ≤ 1.5 × ULN, with activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. Female participants of childbearing age must undergo a serum pregnancy test within 3 days before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive measure (such as an intrauterine device, contraceptive pill, or condom) during the study period and within 6 months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective contraception methods during the study period and within 6 months after the last study administration.

排除标准：

(1)既往或现患其它类型恶性肿瘤，但应除外以下情形： a)已根治的皮肤基底细胞癌、浅表膀胱癌、皮肤鳞状细胞癌或原位宫颈癌； b)已根治且五年内无复发的第二原发癌； (2)对于研究药物任何成分过敏者或既往有严重过敏史的患者； (3)首次研究治疗前接受过以下任一治疗或药物： a)首次研究药物治疗前4周内进行过大手术或发生严重创伤（大手术的定义为任何进行了广泛切除的侵入性手术或者需要打开间皮细胞屏障（如胸膜腔、腹膜、脑膜）的手术。但是因诊断需要进行的组织活检是允许的。严重创伤指有未愈合的伤口、溃疡或骨折； b)首次研究药物治疗前2周内有抗肿瘤适应症的中（成）药治疗。 c)首次给药前4周内接受过抗肿瘤治疗（包括化疗、放疗、免疫治疗、靶向治疗、生物治疗或肿瘤栓塞术）；如为口服氟尿嘧啶类药物和内分泌治疗，停药≤2周；如为亚硝基脲、丝裂霉素或单克隆抗体，停药≤6周。如果因为日程安排或药物PK特性导致洗脱时间不充分，则需要和申办者讨论; d)首次给药前1周内，接受过已知可以显著延长QT间期的药物（如Ia类和III类抗心律失常药）； (4)有中枢神经系统转移（非肿瘤脑膜转移患者）或脊髓压迫病史的患者，如果明确接受过治疗、临床稳定、无症状且在研究首次给药前停用抗惊厥药和类固醇4周后临床表现稳定，则可以入组研究； (5)具有症状的、已播散到内脏的、短期内有出现危及生命的并发症风险的晚期患者，首次给药前三周内进行过穿刺引流的有胸腔积液、腹腔积液、心包积液的患者； (6)主要血管浸润的影像学证据（如肺动脉、上腔静脉或下腔静脉），肿瘤明显入侵食管或胃肠道病灶相邻器官（大动脉或气管或胃肠道）导致具有较高的出血或瘘管风险；气管腔内支架植入术后的患者。 (7)筛选前的6个月内，有心血管系统疾病符合下面任一条： a)心功能≥纽约心脏协会（NYHA）Ⅱ级的充血性心力衰竭；左心室射血分数（LVEF）＜50%； b)需要药物治疗的严重心律失常； c)Fridericia公式校正心率后的QT间期（QTcF）值，男性＞450毫秒，女性＞470毫秒，或存在尖端扭转性室性心动过速的危险因素，如经研究者判断有临床意义的低钾血症、家族性长QT综合征病史或家族性心律失常病史（如预激综合征）； d)给药前六个月内发生过不稳定心绞痛、心肌梗死、冠心病、脑血管意外等，或接受心脏血运重建术； e)过去2年内有≥3级的血栓栓塞事件病史，或入组前2个月内具有血栓或出血倾向证据或病史的患者，无论严重程度如何; (8)筛选期电解质紊乱者； (9)经系统治疗未控制稳定的系统性疾病，如糖尿病，高血压等； (10)现患有突发性肺部疾病，间质性肺病或肺炎，肺纤维化，急性肺部疾病等，由于放疗诱发局部间质性肺炎除外； (11)具有明确的胃肠道出血倾向的患者，包括如下情况：有局部活动性溃疡病灶，或大便潜血（≥2+）；大便隐血1+者且存在原发病灶的，必须胃镜或肠镜排除出血或活动性溃疡方可入组；2个月内有黑便、呕血病史者；研究者认为可能发生消化道大出血者； (12)目前有活动性胃/十二指肠溃疡、溃疡性结肠炎等消化道疾病或研究者判定的可能引起消化道穿孔的其他状况；或者既往6个月内有有肠穿孔、肠瘘史, 或经手术治疗后未痊愈者； (13)有活动性感染证据： a)乙型肝炎（HBV）（需同时满足乙型肝炎病毒表面抗原（HBsAg）阳性，且HBV-DNA≥2000 IU/ml）； b)丙型肝炎（HCV）（需同时满足丙肝抗体（HCV-Ab）阳性、HCV-RNA高于分析方法的检测下限）； c)在筛选期间/首次给药前出现不明原因的发热>38.5°C或任何需要全身治疗的感染（经研究者判断，因肿瘤原因导致的发热可以入组）； d)通过病史或计算机断层成像（CT）检查发现有活动性肺结核感染，或入组前1年内有活动性肺结核感染病史的患者，或超过1年以前有活动性肺结核感染病史但未经正规治疗； e)人类免疫缺陷病毒（HIV）或梅毒螺旋体抗体阳性者； (14)具有影响口服药物的多种因素（例如，无法吞咽、顽固性呕吐、胃肠道吸收不良、慢性腹泻和肠梗阻等），或存在经研究者判断严重影响胃肠道吸收的状况； (15)既往有明确的神经或精神障碍史，包括癫痫或痴呆； (16)有酒精或药物依赖，或有晕针、晕血史，或不能耐受静脉穿刺采血的患者； (17)习惯性饮用葡萄柚汁或过量茶、咖啡和/或含咖啡因的饮料，且在试验期间无法戒断者； (18)首次给药前4周内接受过任何研究性药物，或同时参加另外一项临床研究（但除外：患者参与的是观察性、非干预性的临床研究，或正处于干预性临床研究的随访期；或上次研究用药已经超过5个半衰期）； (19)处于妊娠期或哺乳期，或基线妊娠检测试验阳性的女性患者； （20）研究者认为不适合纳入本研究的患者。

Exclusion criteria：

(1) Previous or current malignant tumors of other types, except for the following: a) Radically treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical cancer in situ; b) Second primary cancers that have been eradicated and have not recurred within five years; (2) Patients who are allergic to any component of the study drug or have a previous history of severe allergy; (3) Received any of the following treatments or medications prior to the first study treatment: a) Major surgery or severe trauma within 4 weeks prior to the first study drug treatment (major surgery is defined as any invasive procedure in which extensive resection is performed or in which the mesothelial cell barrier (e.g., pleural cavity, peritoneum, meninges) is required to be opened. However, tissue biopsies required for diagnostic purposes are permitted. Severe trauma is defined as the presence of unhealed wounds, ulcers, or fractures; b) Chinese (adult) medicine therapy with an antitumor indication within 2 weeks prior to the first study drug treatment. c) Anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biologic therapy, or tumor embolization) within 4 weeks prior to the first dose of study medication; ≤ 2 weeks of discontinuation in the case of oral fluorouracil analogs and endocrine therapy; ≤ 6 weeks of discontinuation in the case of nitrosoureas, mitomycin, or monoclonal antibodies. If the elution time is not adequate due to scheduling or drug PK properties, this needs to be discussed with the sponsor ;-) d) Received a drug known to significantly prolong the QT interval (e.g., class Ia and class III antiarrhythmics) within 1 week prior to the first dose; (4) Patients with a history of CNS metastases (non-tumor meningeal metastases in patients) or spinal cord compression may be enrolled in the study if definitively treated, clinically stable, asymptomatic, and clinically stable after discontinuing anticonvulsants and steroids for 4 weeks prior to the first dose of the study; (5) Patients with symptomatic, advanced disease that has disseminated to the viscera and is at risk of life-threatening complications in the short term, and patients with pleural effusions, peritoneal effusions, and pericardial effusions who have had a puncture and drainage within three weeks prior to the first dose of study drug; (6) Imaging evidence of major vascular infiltration (e.g., pulmonary artery, superior vena cava, or inferior vena cava), significant tumor invasion into the esophagus or organs adjacent to the gastrointestinal tract lesion (large arteries or trachea or gastrointestinal tract) resulting in a high risk for hemorrhage or fistulae; and patients with post-tracheal endoluminal stenting. (7) Cardiovascular disease meeting any of the following criteria in the 6 months prior to screening: a) Congestive heart failure with cardiac function ≥ New York Heart Association (NYHA) class II; left ventricular ejection fraction (LVEF) <50%; b)Severe arrhythmia requiring pharmacologic treatment; c) Fridericia formula-corrected heart rate QT interval (QTcF) values >450 ms in men and >470 ms in women, or the presence of risk factors for tip-twisting ventricular tachycardia, such as hypokalemia judged by the investigator to be clinically significant, a history of familial long QT syndrome, or a history of familial arrhythmias (e.g., pre-excitation syndrome); d) Unstable angina, myocardial infarction, coronary artery disease, or cerebrovascular accident within six months prior to dosing, or undergoing cardiac revascularization; e) Patients with a history of a grade ≥3 thromboembolic event within the past 2 years, or evidence or history of thrombotic or bleeding tendencies, regardless of severity, within 2 months prior to enrollment;. (8) Those with electrolyte disturbances during the screening period; (9) Systemic diseases that have not been stabilized by systemic therapy, such as diabetes mellitus and hypertension; (10) Currently suffering from sudden lung disease, interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, etc., except for localized interstitial pneumonia induced due to radiotherapy; (11) Patients with a definite tendency to gastrointestinal bleeding, including the following: those with locally active ulcerative lesions, or fecal occult blood (≥2+); those with fecal occult blood of 1+ and the presence of a primary lesion must be gastroscopically or enteroscopically excluded from bleeding or active ulcers before enrollment; those with history of black stools and vomiting of blood within 2 months; and those who, in the investigator's opinion, may have gastrointestinal hemorrhage; (12) Current active gastric/duodenal ulcer, ulcerative colitis, or other conditions that, in the judgment of the investigator, may lead to perforation of the gastrointestinal tract; or history of intestinal perforation or fistula within the past 6 months, or failure to recover after surgical treatment; (13) Evidence of active infection: a)Hepatitis B (HBV) (both hepatitis B virus surface antigen (HBsAg) positivity and HBV-DNA ≥ 2000 IU/ml are required); b) Hepatitis C (HCV) (both hepatitis C antibody (HCV-Ab) positivity and HCV-RNA above the lower limit of detection of the analytical method); c) Unexplained fever >38.5°C or any infection requiring systemic therapy during the screening period/prior to the first dose (fever due to oncologic causes may be enrolled at the discretion of the investigator); d) Active tuberculosis infection by history or computed tomography (CT), or patients with a history of active tuberculosis infection within 1 year prior to enrollment, or a history of active tuberculosis infection more than 1 year prior without formal treatment; e) Persons who are positive for human immunodeficiency virus (HIV) or syphilis spirochete antibodies; (14) Have multiple factors that interfere with oral administration of medications (e.g., inability to swallow, intractable vomiting, gastrointestinal malabsorption, chronic diarrhea, and intestinal obstruction), or conditions that, in the judgment of the investigator, severely interfere with gastrointestinal absorption; (15) A previous history of a definite neurologic or psychiatric disorder, including epilepsy or dementia; (16) Patients with alcohol or drug dependence, or a history of needle or blood sickness, or who cannot tolerate blood collection by venipuncture; (17) Habitual consumption of grapefruit juice or excessive amounts of tea, coffee and/or caffeinated beverages that cannot be stopped during the trial; (18) Received any investigational medication within 4 weeks prior to the first dose or concurrently enrolled in another clinical study (except: the patient is participating in an observational, non-interventional clinical study or is in the follow-up period of an interventional clinical study; or the last investigational dose has exceeded 5 half-lives); (19) Female patients who are pregnant or breastfeeding, or who have a positive baseline pregnancy detection test; (20) Patients who, in the opinion of the investigator, are not suitable for inclusion in this study.

研究实施时间：

Study execute time：

从 From 2024-02-20 00:00:00至 To 2027-02-19 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-02-20 00:00:00 至 To 2027-02-19 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 126

Group：

Experimental group

Sample size：

干预措施：

ABP1019A 片

干预措施代码：

Intervention：

ABP1019A Tablet

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

 北京市 

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

 中国医学科学院肿瘤医院 

单位级别：

 三级甲等 

Institution
hospital：

Cancer Hospital Chinese Academy of Medical Sciences

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

剂量限制性毒性（DLT）

指标类型：

主要指标

Outcome：

Dose restriction toxicity (DLT)

Type：

Primary indicator

测量时间点：

Ⅰ期

测量方法：

Measure time point of outcome：

Phase 1

Measure method：

指标中文名：

最大耐受剂量（MTD）

指标类型：

主要指标

Outcome：

Maximum tolerated dose (MTD)

Type：

Primary indicator

测量时间点：

Ⅰ期

测量方法：

Measure time point of outcome：

Phase 1

Measure method：

指标中文名：

不良事件（AE）、严重不良事件（SAE）、实验室检查、生命体征

指标类型：

主要指标

Outcome：

Adverse events (AE), serious adverse events (SAE),Lab tests, vital signs

Type：

Primary indicator

测量时间点：

Ⅰ期

测量方法：

Measure time point of outcome：

Phase 1

Measure method：

指标中文名：

客观缓解率（ORR）

指标类型：

主要指标

Outcome：

Objective response rate (ORR)

Type：

Primary indicator

测量时间点：

Ⅱ期

测量方法：

Measure time point of outcome：

Phase 2

Measure method：

指标中文名：

单/多次给药ABP1019A 片的药代动力学参数

指标类型：

次要指标

Outcome：

Pharmacokinetic parameters of single / multiple administration of ABP1019A tablet

Type：

Secondary indicator

测量时间点：

Ⅰ期

测量方法：

Measure time point of outcome：

Phase 1

Measure method：

指标中文名：

矫正后Q-T间期

指标类型：

次要指标

Outcome：

QTcF

Type：

Secondary indicator

测量时间点：

Ⅰ期

测量方法：

Measure time point of outcome：

Phase 1

Measure method：

指标中文名：

客观缓解率（ORR）、疾病控制率（DCR）、缓解持续时间（DOR）、无进展生存期（PFS）、6个月的无进展生存率、持续反应率和2年内总生存期。

指标类型：

次要指标

Outcome：

Objective response rate (ORR),disease control rate (DCR),duration of response (DOR),Progression-free survival (PFS),6-month progression free survival, sustained response rate, and overall survival within 2 years.

Type：

Secondary indicator

测量时间点：

Ⅰ期

测量方法：

Measure time point of outcome：

Phase 1

Measure method：

指标中文名：

不良事件（AE）、严重不良事件（SAE）、实验室检查、生命体征

指标类型：

次要指标

Outcome：

Adverse events (AE), serious adverse events (SAE),Lab tests, vital signs

Type：

Secondary indicator

测量时间点：

Ⅱ期

测量方法：

Measure time point of outcome：

Phase 2

Measure method：

指标中文名：

疾病控制率（DCR）、缓解持续时间（DOR）、无进展生存期（PFS）、6个月的无进展生存率、持续反应率和2年内总生存期。

指标类型：

次要指标

Outcome：

disease control rate (DCR),duration of response (DOR),Progression-free survival (PFS),6-month progression free survival, sustained response rate, and overall survival within 2 years.

Type：

Secondary indicator

测量时间点：

Ⅱ期

测量方法：

Measure time point of outcome：

Phase 2

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：

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 65 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：

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）：

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：

ORACLE-RDC

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

ORACLE-RDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-02-20 17:52:53