ChiCTR2300075521 版本V1.0 版本创建时间2023/09/07 14:56:41 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：

ChiCTR2300075521 

最近更新日期：

Date of Last Refreshed on：

2023-09-07 14:56:08 

注册时间：

Date of Registration：

2023-09-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价SPH4336单药或联合卡度尼利单抗治疗晚期实体瘤（包括晚期高分化/去分化脂肪肉瘤）有效性和安全性的随机、开放、Ⅰb/Ⅱa 期临床研究

Public title：

Randomized, open, Phase Ib/IIa trial to evaluate the efficacy and safety of SPH4336 monotherapy or in combination with cadonilimab in the treatment of advanced solid tumors, including advanced highly differentiated/dedifferentiated liposarcoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价SPH4336单药或联合卡度尼利单抗治疗晚期实体瘤（包括晚期高分化/去分化脂肪肉瘤）有效性和安全性的随机、开放、Ⅰb/Ⅱa 期临床研究

Scientific title：

Randomized, open, Phase Ib/IIa trial to evaluate the efficacy and safety of SPH4336 monotherapy or in combination with cadonilimab in the treatment of advanced solid tumors, including advanced highly differentiated/dedifferentiated liposarcoma

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：

刘杰 

研究负责人：

姜愚 

Applicant：

Liu Jie 

Study leader：

Jiang Yu 

申请注册联系人电话：

Applicant telephone：

+86 134 3815 4839

研究负责人电话：

Study leader's telephone：

+86 28 8542 2851

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：

liujie382486310@126.com

研究负责人电子邮件：

Study leader's E-mail：

hxlcyiglb@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：

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan

研究负责人通讯地址：

四川省成都市武侯区国学巷37号

Applicant address：

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan

Study leader's address：

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan

申请注册联系人邮政编码：

Applicant postcode：

610041

研究负责人邮政编码：

Study leader's postcode：

610041

申请人所在单位：

四川大学华西医院

Applicant's institution：

West China Hospital, Sichuan University

研究负责人所在单位：

四川大学华西医院

Affiliation of the Leader：

West China Hospital, Sichuan 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：

2023年临床试验(西药)审(122)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：

四川大学华西医院生物医学伦理审查委员会

Name of the ethic committee：

Ethics Committee of West China Hospital of Sichuan University

伦理委员会批准日期：

Date of approved by ethic committee：

2023-06-21 00:00:00

伦理委员会联系人：

李娜

Contact Name of the ethic committee：

Li Na

伦理委员会联系地址：

四川省成都市武侯区国学巷37号

Contact Address of the ethic committee：

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 28 8542 2654

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：

四川大学华西医院

Primary sponsor：

West China Hospital, Sichuan University

研究实施负责（组长）单位地址：

四川省成都市武侯区国学巷37号

Primary sponsor's address：

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan

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

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

四川大学华西医院

具体地址：

武侯区国学巷37号

Institution
hospital：

West China Hospital, Sichuan University

Address：

37 Guoxue Lane, Wuhou District

经费或物资来源：

上海医药集团股份有限公司

Source(s) of funding：

Shanghai Pharmaceutical Group Co., Ltd

Target disease：

Advanced highly differentiated/dedifferentiated liposarcoma

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：

随机平行对照 

Study design：

Parallel 

研究目的：

剂量递减阶段：评价SPH4336 联合卡度尼利单抗的耐受性。 剂量扩展阶段：初步评估SPH4336 单药或联合卡度尼利单抗的有效性。  

Objectives of Study：

Dose reduction stage: Evaluate the tolerance of SPH4336 combined with cadonilamab. Dose extension stage: Preliminary evaluation of the efficacy of SPH4336 monotherapy or combination with cadonilamab.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

入组标准 受试者必须符合以下所有标准，才能入选本研究： (1) 受试者自愿参加本研究，并签署知情同意书。 (2) 签署知情同意书时年龄≥18且≤75周岁，性别不限。 (3) ECOG评分0~1分（不满足ECOG评分要求的截肢患者需使用KPS复评，≥70分则可入组）。 (4) 预期生存期≥3个月。 (5) 剂量递减阶段入组病理学确诊的不能进行根治性手术/其他局部治疗的晚期实体瘤患者（包括但不限于晚期高分化/去分化脂肪肉瘤患者等），并满足以下至少一种情形： a) 经标准治疗无效。 b) 不能耐受标准治疗。 c) 无标准治疗方法。 d) 无经济条件进行标准治疗。 e) 患者拒绝进行标准治疗。 (6) 剂量扩展阶段入组经病理学确诊的不能进行根治性手术/其他局部治疗的复发或转移性晚期高分化/去分化脂肪肉瘤患者，患者还必须在研究药物首次给药前6个月内有疾病进展的证据，且既往接受过≥2种系统性药物（该两种药物可为联合或单独使用，其中必须包括蒽环类，其他药物可包括安罗替尼等）治疗失败。 *治疗失败指治疗期间或距离末次用药的6个月内出现疾病进展或不能耐受。 (7) 根据RECIST v1.1标准，剂量扩展阶段受试者需至少有1个可测量的病灶，既往接受过放疗或其他局部治疗的病灶一般不选作可测量病灶，除非证实该病灶在入组前出现进展。 (8) 开始研究治疗前实验室检查结果满足以下器官功能要求： a) 骨髓功能：中性粒细胞绝对值≥1.5×109/L（进行实验室检查前7天内未接受过粒细胞集落刺激因子治疗）；血小板≥100×109/L（进行实验室检查前7天内未输注过血小板或促血小板生长因子）；血红蛋白≥90 g/L（进行实验室检查前7天内未输血或使用促红细胞生成素）。 b) 肝功能：白蛋白≥30 g/L（进行实验室检查前7天内未输注白蛋白）；总胆红素≤1.5×正常值上限（ULN）（Gilbert's综合征受试者可≤3×ULN）；ALT、AST、ALP≤2.5×ULN（存在肝转移时，ALT或AST≤5×ULN；存在骨转移时，ALP≤5×ULN）。 c) 肾功能：血清肌酐≤1.5×ULN，或Cockcroft-Gault公式法计算肌酐清除率（CrCl）≥60mL/min/1.73 m2。 d) 凝血功能：国际标准化比值（INR）≤1.5，活化部分凝血活酶时间（APTT）≤1.5×ULN（适用于未使用抗凝治疗者，受试者伴有基础疾病需要长期使用抗凝药物者，抗凝药物需要在一个稳定的剂量）。 (9) 开始研究治疗前既往抗肿瘤药物治疗的周围神经毒性反应已恢复至≤2级，其他可逆性毒性反应已恢复至≤1级（根据CTCAE 5.0版），但脱发/色素沉着（任何等级）以及其他经研究者评估后认为受试者接受研究治疗获益>风险的毒性不受此限制。 (10) 受试者（包括女性和男性）同意从签署知情同意书起至末次使用研究药物后180天采用有效的避孕措施避孕。

Inclusion criteria

Inclusion criteria Participants must meet all of the following criteria in order to be selected for this study: (1) The subjects voluntarily participated in this study and signed an informed consent form. (2) At the time of signing the informed consent form, the age is ≥ 18 and ≤ 75 years old, regardless of gender. (3) The ECOG score is 0-1 points (amputees who do not meet the ECOG score requirements need to use KPS re evaluation, and those who score ≥ 70 points can be included in the group). (4) The expected survival period is ≥ 3 months. (5) Patients with advanced solid tumor (including but not limited to patients with advanced well differentiated/dedifferentiated Liposarcoma, etc.) who cannot be treated by radical surgery/other local treatment and who are included in the group with pathological diagnosis in the dose decreasing stage, shall meet at least one of the following conditions: a) Invalid after standard treatment. b) Unable to tolerate standard treatment. c) There is no standard treatment method. d) Standard treatment without economic conditions. e) The patient refused to receive standard treatment. (6) In the dose expansion stage, patients with recurrent or metastatic advanced well differentiated/dedifferentiated Liposarcoma who cannot undergo radical surgery/other local treatment and are confirmed pathologically must also have evidence of disease progression within 6 months before the first administration of the study drug, And have previously received ≥ 2 systemic drugs (these two drugs can be used in combination or alone, which must include anthracyclines, while other drugs can include arotinib, etc.) for treatment failure. *Treatment failure refers to the progression or intolerance of the disease during the treatment period or within 6 months from the last medication. (7) According to the RECIST v1.1 standard, subjects in the dose extension stage need to have at least one measurable lesion. Lesions that have previously received radiotherapy or other local treatments are generally not selected as measurable lesions unless it is confirmed that the lesion has progressed before enrollment. (8) The laboratory examination results before starting the study treatment meet the following organ functional requirements: a) Bone marrow function: Absolute value of neutrophils ≥ 1.5 × 109/L (no granulocyte Colony-stimulating factor treatment within 7 days before laboratory examination); Platelets ≥ 100 × 109/L (without transfusion of platelets or platelet growth factors within 7 days prior to laboratory examination); Hemoglobin ≥ 90 g/L (no blood transfusion or use of erythropoietin within 7 days before laboratory examination). b) Liver function: Albumin ≥ 30 g/L (no albumin infusion within 7 days prior to laboratory examination); Total bilirubin ≤ 1.5 × Upper limit of normal value (ULN) (Gilbert's syndrome subjects can be ≤ 3 × ULN); ALT, AST, ALP ≤ 2.5 × ULN (ALT or AST ≤ 5 in the presence of liver metastasis) × ULN; When there is bone metastasis, ALP ≤ 5 × ULN). c) Renal function: serum creatinine ≤ 1.5 × Calculate creatinine clearance rate (CrCl) ≥ 60mL/min/1.73 m2 using ULN or Cockcroft Fault formula method. d) Coagulation function: International standardized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (applicable to unused anti (9) Prior to the start of the study treatment, the peripheral neurotoxicity response to previous anti-tumor drug treatment has returned to ≤ 2 levels, and other reversible toxicity reactions have returned to ≤ 1 levels (according to CTCAE version 5.0). However, hair loss/pigmentation (at any level) and other toxicity that the researcher assessed as beneficial>at risk for the subject receiving the study treatment are not subject to this limitation. (10) The subjects (including women and men) agreed to use effective contraception methods 180 days after signing the informed consent form and the last use of the study drug.

排除标准：

排除标准 受试者若符合以下标准的任何一条者，则不能入选本项研究： (1) 既往接受过任何CDK4/6抑制剂。 (2) 已知存在中枢神经系统转移者（针对未转移至脑干或脑膜的受试者，经治疗后无症状且距离研究治疗稳定≥3个月的可以纳入）。 (3) 开始研究治疗前28天内接受过化疗、生物治疗、免疫治疗等抗肿瘤药物治疗，特殊的排除标准见下： a) 开始研究治疗前6周内接受过亚硝基脲或丝裂霉素C治疗。 b) 开始研究治疗前2周内接受过口服氟尿嘧啶类和小分子靶向药物治疗。 (4) 签署知情同意书时仍在接受有抗肿瘤适应症的中成药治疗。 (5) 开始研究治疗前28天内接受过手术且未从手术的不良反应中恢复。或计划在研究期间进行针对晚期实体瘤（包括脂肪肉瘤）的手术治疗。 (6) 开始研究治疗前5年内有其他恶性肿瘤病史（除外已治愈的基底细胞皮肤癌、宫颈原位癌、甲状腺乳头状癌等）。 (7) 开始研究治疗前2年内存在需要系统治疗的活动性自身免疫性疾病，或研究者判断存在可能复发或计划治疗的自身免疫性疾病。但符合以下情况的受试者可以入组： a) 不需系统治疗的皮肤病（如：白癜风、脱发、银屑病或湿疹）； b) 由自身免疫性甲状腺炎引起的甲状腺功能减退，仅需要稳定剂量的激素替代治疗； c) 仅需要稳定剂量的胰岛素替代治疗的I型糖尿病； d) 童年期哮喘已完全缓解，成人后无需任何干预； e) 研究者判断所患疾病在无外部触发因素的情况下不会复发。 (8) 存在首次开始研究治疗前2周内以及研究治疗期间需要使用全身性皮质类固醇（>10 mg每日泼尼松或当量）或其他免疫抑制药物治疗的疾病。但符合以下情况的受试者可以入组： a) 局部使用皮质类固醇、鼻喷剂和吸入性类固醇。 b) 糖皮质激素作为输液相关反应或过敏反应预处理（如：CT检查前用药等） c) 正在进行相关的替代治疗，如甲状腺素、胰岛素、肾或垂体功能不全的生理性皮质类固醇替代治疗等。 d) 使用低剂量皮质类固醇治疗直立性低血压。 (9) 有临床意义的心脑血管疾病，存在以下情况之一： a) 开始研究治疗前6个月内发生过缺血性脑卒中（腔隙性脑栓塞）或严重的血栓栓塞疾病。 b) 开始研究治疗前6个月内发生过心肌梗死、不稳定型心绞痛、充血性心力衰竭、严重的心率失常。 c) 开始研究治疗前存在纽约心脏病学会NYHA心功能不全分级≥Ⅱ级。 d) 开始研究治疗前QTcF均值≥470 ms。 e) 开始研究治疗前心脏左室射血分数（LVEF）≤50%。 (10) 开始研究治疗前存在影响药物服用或影响胃肠道吸收功能的疾病且经研究者评估不能入选本研究。 (11) 既往存在器官移植史者，包括同种异体干细胞移植（角膜移植除外）。 (12) 开始研究治疗前，HBsAg阳性且HBV DNA＞500 IU/ml或2500 拷贝/mL者或研究中心检测下限，或HCV抗体阳性且HCV RNA阳性者，或已知的HIV感染者，或已知存在活动性结核（TB）。 (13) 已知存在间质性肺病或非感染性肺炎，该疾病目前有症状或既往需要系统性糖皮质激素治疗，研究者判断可能影响与研究治疗相关的毒性评估或管理。 (14) 伴有其他任何严重的、进展性、或未能控制的疾病，经研究者判断不适宜入组，包括但不限于： a) 需全身治疗的感染。 b) 开始研究治疗前存在无法通过引流或其他方法控制的第三间隙积液（包括大量胸水或腹水）且经研究者评估不能入选本研究（因低蛋白血症引起第三间隙积液的受试者可以入组）。 c) 既往凝血障碍病史或存在严重出血倾向，开始研究治疗前1个月内发生过显著出血症状，如胃肠道出血。 d) 既往患有任何严重精神疾病。 e) 患有其他研究者认为接受本研究治疗风险大于获益的疾病。 (15) 已知既往发生过3-4级免疫相关不良反应的受试者，且经研究者判断不能纳入。 (16) 签署知情同意书时正在接受强效CYP3A4抑制剂或诱导剂的患者。 (17) 严重过敏性疾病史、严重药物（含未上市的试验药物）过敏史或已知对本试验研究药物任何成分过敏，包括已知的对任何单克隆抗体的严重超敏反应。 (18) 开始研究治疗前28天内参加过任何药物临床试验并使用了试验药物者。 (19) 开始研究治疗前30天内或计划在研究期间或停药后一个月内接种活（减毒）疫苗的患者。 (20) 处于妊娠期或哺乳期的女性（签署知情同意书前同意停止哺乳者可纳入）。 (21) 研究者认为有任何不宜入选本研究的其他原因。

Exclusion criteria：

Exclusion criteria Subjects who meet any of the following criteria are not eligible for inclusion in this study: (1) I have received any CDK4/6 inhibitors in the past. (2) The patients with known central nervous system metastasis (those who have not transferred to the brain stem or meninges and who are Asymptomatic after treatment and have been stable from the study treatment for ≥ 3 months can be included). (3) Within 28 days prior to the start of the study, chemotherapy, biological therapy, immunotherapy, and other anti-tumor drug treatments were received. The specific exclusion criteria are as follows: a) Nitroso urea or Mitomycin C treatment was received within 6 weeks before starting the study treatment. b) Oral fluorouracil and small molecule targeted drugs were received within 2 weeks before the start of the study treatment. (4) At the time of signing the informed consent, he was still receiving traditional Chinese patent medicines and simple preparations with anti-tumor indications. (5) I underwent surgery within 28 days before starting the study and did not recover from adverse reactions during the surgery. Or plan to carry out surgical treatment for advanced solid tumors (including Liposarcoma) during the study period. (6) There was a history of other malignant tumors within 5 years before starting the study treatment (except cured basal cell skin cancer, cervical Carcinoma in situ, thyroid papillary carcinoma, etc.). (7) There are active autoimmune diseases that require systematic treatment within 2 years prior to the start of the study, or the researcher determines the existence of autoimmune diseases that may recur or plan treatment. However, subjects who meet the following conditions can be enrolled: a) Skin diseases that do not require systematic treatment (such as Vitiligo, alopecia, psoriasis or eczema); b) Hypothyroidism caused by autoimmune Thyroiditis requires only a stable dose of hormone replacement therapy; c) Type I diabetes requiring only a stable dose of insulin replacement therapy; d) Childhood asthma has completely relieved, and no intervention is required in adulthood; e) Researchers have determined that the disease will not recur without external triggering factors. (8) There are diseases that need to be treated with systemic Corticosteroid (>10 mg prednisone daily or equivalent) or other immunosuppressive drugs within 2 weeks before the first start of the study treatment and during the study treatment. However, subjects who meet the following conditions can be enrolled: a) Local use of Corticosteroid, nasal sprays and inhaled Sex hormone. b) Glucocorticoids as pretreatment for infusion related reactions or allergic reactions (such as medication before CT examination) c) Relevant replacement therapy is being carried out, such as Thyroxine, insulin, physiological Corticosteroid replacement therapy with renal or pituitary dysfunction. d) Low dose Corticosteroid was used to treat orthostatic Hypotension. (9) The clinically significant cardio cerebral Vascular disease has one of the following conditions: a) I have experienced ischemic stroke (lacunar cerebral embolism) or severe thromboembolic disease within 6 months before starting the study treatment. b) Myocardial infarction, unstable angina pectoris, congestive heart failure, and severe heart rate abnormalities occurred within 6 months before starting the study treatment. c) Prior to the start of the study treatment, there was a NYHA cardiac insufficiency rating of ≥ Level II at the New York Heart Association. d) QTcF before starting the study treatment e) Before starting the study, the left ventricular ejection fraction (LVEF) of the heart was ≤ 50%. (10) There are diseases that affect drug use or gastrointestinal absorption function before starting the research treatment, and after evaluation by the researcher, they cannot be selected for this study. (11) Individuals with a history of organ transplantation, including allogeneic stem cell transplantation (excluding corneal transplantation). (12) Before starting the study treatment, individuals with HBsAg positive and HBV DNA>500 IU/ml or 2500 copies/mL, or the lower detection limit of the research center, or individuals with HCV antibody positive and HCV RNA positive, or known HIV infected individuals, or known to have active tuberculosis (TB). (13) The presence of interstitial lung disease or non infectious pneumonia is known, and the disease is currently symptomatic or requires systemic glucocorticoid treatment in the past. Researchers have determined that it may affect the toxicity assessment or management related to the study treatment. (14) Accompanied by any other serious, progressive, or uncontrollable diseases, and judged by the researcher as unsuitable for enrollment, including but not limited to: a) Infections that require systemic treatment. b) Before starting the study treatment, there was a third space effusion (including a large amount of pleural or ascitic fluid) that could not be controlled through drainage or other methods, and after evaluation by the researcher, it was not eligible for inclusion in this study (subjects with third space effusion caused by hypoproteinemia can be included). c) Previous history of coagulation disorders or a tendency towards severe bleeding, with significant bleeding symptoms such as gastrointestinal bleeding occurring within one month prior to the start of the study treatment. d) Previously suffering from any serious mental illness. e) Suffering from diseases that other researchers believe the risk of receiving treatment in this study outweighs the benefits. (15) Subjects who have previously experienced levels 3-4 immune related adverse reactions are known and cannot be included according to the judgment of the researchers. (16) Patients who are receiving strong CYP3A4 inhibitors or inducers at the time of signing the informed consent form. (17) A history of severe allergic diseases, allergies to severe drugs (including unlisted investigational drugs), or known allergies to any component of the investigational drug, including known severe hypersensitivity reactions to any monoclonal antibody. (18) Those who have participated in any drug clinical trial and used the investigational drug within 28 days before starting the study treatment. (19) Patients who are scheduled to receive live (attenuated) vaccines within 30 days before starting treatment or within one month after discontinuation of the study. (20) Women who are pregnant or breastfeeding (those who agree to stop breastfeeding before signing the informed consent form can be included). (21) The researcher believes that there are any other reasons that are not suitable for inclusion in this study.

研究实施时间：

Study execute time：

从 From 2023-08-20 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-09-10 00:00:00 至 To 2025-03-09 00:00:00  

干预措施：

Interventions：

组别：

剂量递减组

样本量：

6

Group：

Dose reduction group

Sample size：

干预措施：

SPH4336片+卡度尼利单抗

干预措施代码：

Intervention：

SPH4336 +cadonilimab

Intervention code：

组别：

剂量扩展组

样本量：

15

Group：

Dose expansion group

Sample size：

干预措施：

SPH4336片

干预措施代码：

Intervention：

SPH4336

Intervention code：

组别：

剂量扩展组

样本量：

15

Group：

Dose expansion group

Sample size：

干预措施：

卡度尼利单抗

干预措施代码：

Intervention：

cadonilimab

Intervention code：

组别：

剂量扩展组

样本量：

15

Group：

Dose expansion group

Sample size：

干预措施：

SPH4336片+卡度尼利单抗

干预措施代码：

Intervention：

SPH4336+cadonilimab

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川省 

市(区县)：

  

Country：

China 

Province：

Sichuan 

City：

 

单位(医院)：

四川大学华西医院 

单位级别：

三甲 

Institution
hospital：

West China Hospital, Sichuan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

剂量递减阶段： 耐受性

指标类型：

主要指标

Outcome：

Dose reduction stage: tolerance

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

剂量扩展阶段： 研究者评估的无进展生存期（PFS）

指标类型：

主要指标

Outcome：

Dose extension stage: Investigator evaluated progression free survival (PFS)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

12 周的PFS 率（PFR）

指标类型：

次要指标

Outcome：

12 week PFS rate (PFR)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

剂量递减阶段：无进展生存期（PFS）

指标类型：

次要指标

Outcome：

Dose reduction stage: 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：

总生存期（OS）

指标类型：

次要指标

Outcome：

Total survival time (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：

研究者评估的客观缓解率（ORR）

指标类型：

次要指标

Outcome：

Objective response rate (ORR) evaluated by researchers

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

研究者评估的疾病控制率（DCR）

指标类型：

次要指标

Outcome：

Disease control rate (DCR) evaluated by researchers

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

研究者评估的缓解持续时间（DoR）

指标类型：

次要指标

Outcome：

Investigator evaluated duration of relief (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：

SPH4336 的药代动力学（PK）特征

指标类型：

次要指标

Outcome：

Pharmacokinetic (PK) characteristics of SPH4336

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

安全性如生命体征、体格检查、不良事件、临床实验室检查结果等

指标类型：

次要指标

Outcome：

Safety such as vital signs, physical examinations, adverse events, clinical laboratory test results, etc

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：

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：

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）：

由研究者使用随机系统随机分配剂量扩展组受试者组别

Randomization Procedure (please state who generates the random number sequence and by what method)：

Randomly allocate dose expansion groups to subject groups by researchers using a random system

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：

NA

Blinding：

NA

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）：

NA

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

NA

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

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

CRF

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：

  2023-09-07 14:56:08