注册号：
Registration number：
ChiCTR2600123594 最近更新日期：
Date of Last Refreshed on：
2026-04-28 10:32:38 注册时间：
Date of Registration：
2026-04-28 00:00:00 注册号状态：
预注册Registration Status：
Prospective registration注册题目：
评估注射用HS-20093 联合阿得贝利单抗对比多西他赛用于既往接受过以含铂化疗为基础的标准治疗后进展或复发的驱动基因阴性的晚期或转移性非鳞状非小细胞肺癌的有效性和安全性的多中心、随机、开放、对照、III 期临床研究（分中心）Public title：
A multicenter, randomized, open-label, controlled, phase III clinical study to evaluate the efficacy and safety of HS-20093 for injection combined with adebrelimab versus docetaxel in patients with driver gene-negative advanced or metastatic non-squamous non-small cell lung cancer who have progressed or relapsed after prior standard platinum-based chemotherapy.注册题目简写：
评估注射用HS-20093 联合阿得贝利单抗对比多西他赛用于驱动基因阴性的晚期或转移性非鳞状非小细胞肺癌的多中心、随机、开放、对照、III 期临床研究（分中心）English Acronym：
A multicenter, randomized, open-label, controlled phase III clinical study (by center) to evaluate HS-20093 for injection combined with adebrelimab versus docetaxel in patients with driver gene-negative advanced or metastatic non-squamous non-small cell lung cancer.研究课题的正式科学名称：
评估注射用HS-20093 联合阿得贝利单抗对比多西他赛用于既往接受过以含铂化疗为基础的标准治疗后进展或复发的驱动基因阴性的晚期或转移性非鳞状非小细胞肺癌的有效性和安全性的多中心、随机、开放、对照、III 期临床研究（分中心）Scientific title：
A multicenter, randomized, open-label, controlled, phase III clinical study to evaluate the efficacy and safety of HS-20093 for injection combined with adebrelimab versus docetaxel in patients with driver gene-negative advanced or metastatic non-squamous non-small cell lung cancer who have progressed or relapsed after prior standard platinum-based chemotherapy.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：
赵艳辉
研究负责人：
邬麟 Applicant：
Zhao Yanhui
Study leader：
Lin Wu 申请注册联系人电话：
Applicant telephone：
+86 186 5210 6586
研究负责人电话：
Study leader's telephone：
+86 731 8976 2302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：
zhaoyh8@hspharm.com
研究负责人电子邮件：
Study leader's E-mail：
wulin-calf@vip.163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：
中国(上海)自由贸易试验区金科路 3728 号11幢
研究负责人通讯地址：
咸嘉湖路582号Applicant address：
Building 11, No. 3728 Jinke Road, China (Shanghai) Pilot Free Trade Zone
Study leader's address：
283 Tongzipo Road, Yuelu District, Changsha City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：
上海翰森生物医药科技有限公司Applicant's institution：
Shanghai Hansoh Biomedical Technology Co., Ltd.研究负责人所在单位：
湖南省肿瘤医院Affiliation of the Leader：
Hunan Cancer Hospital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：
2026药审306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：
湖南省肿瘤医院医学伦理审查委员会Name of the ethic committee：
Medical Ethics Review Committee of Hunan Cancer Hospital伦理委员会批准日期：
Date of approved by ethic committee：
2026-03-18 00:00:00伦理委员会联系人：
杨凤Contact Name of the ethic committee：
Yang Feng伦理委员会联系地址：
咸嘉湖路582号Contact Address of the ethic committee：
283 Tongzipo Road, Yuelu District, Changsha City伦理委员会联系人电话：
Contact phone of the ethic committee：
+86 731 8976 2695
伦理委员会联系人邮箱：
Contact email of the ethic committee：
hnszlyy_irb@163.com研究实施负责（组长）单位：
湖南省肿瘤医院Primary sponsor：
Hunan Cancer Hospital研究实施负责（组长）单位地址：
咸嘉湖路582号Primary sponsor's address：
283 Tongzipo Road, Yuelu District, Changsha City试验主办单位(项目批准或申办者)：
Secondary sponsor：
国家：
中国
省(直辖市)：
湖南省
市(区县)：
Country：
China
Province：
Hunan
City：
单位(医院)：
湖南省肿瘤医院
具体地址：
咸嘉湖路582号
Institution
hospital：
Hunan Cancer Hospital
Address：
283 Tongzipo Road, Yuelu District, Changsha City经费或物资来源：
上海翰森生物医药科技有限公司Source(s) of funding：
Shanghai Hansoh Biomedical Technology Co., Ltd.研究疾病：
晚期或转移性非鳞状非小细胞肺癌 Target disease：
Advanced or metastatic non-squamous non-small cell lung cancer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：
III期临床试验 Study phase：
3研究设计：
随机平行对照 Study design：
Parallel 研究目的：
主要目的：
评价HS-20093 联合阿得贝利单抗对比多西他赛在接受过以含铂化疗为基础的标准治疗后进展或复发的驱动基因阴性的晚期或转移性非鳞状非小细胞肺癌（nsq-NSCLC）患者中的无进展生存期（PFS）（盲态独立中心阅片评估）和总生存期（OS）
次要目的：
1.评价HS-20093 联合阿得贝利单抗对比多西他赛在接受过以含铂化疗为基础的标准治疗后进展或复发的驱动基因阴性的晚期或转移性nsq-NSCLC 患者中的其他有效性指标。
2.评价HS-20093 联合阿得贝利单抗对比多西他赛在接受过以含铂化疗为基础的标准治疗后进展或复发的驱动基因阴性的晚期或转移性nsq-NSCLC 患者中的安全性。
探索性目的：
1. 评价HS-20093 联合阿得贝利单抗在接受过以含铂化疗为基础的标准治疗后进展或复发的驱动基因阴性的晚期或转移性nsq-NSCLC患者中的药代动力学（PK）特征
2.评价HS-20093 联合阿得贝利单抗在接受过以含铂化疗为基础的标准治疗后进展或复发的驱动基因阴性的晚期或转移性nsq-NSCLC患者中的免疫原性
3. 探索注射用HS-20093和/或阿得贝利单抗的PK暴露和临床效应之间的关系
4.探索生物标志物的表达和疗效的相关性 Objectives of Study：
Primary Objectives:To evaluate progression-free survival (PFS) (assessed by blinded independent central review) and overall survival (OS) of HS-20093 combined with adebrelimab versus docetaxel in patients with driver gene-negative advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) who have progressed or relapsed after prior standard platinum-based chemotherapy.# Secondary Objectives:1. To evaluate other efficacy endpoints of HS-20093 combined with adebrelimab versus docetaxel in patients with driver gene-negative advanced or metastatic nsq-NSCLC who have progressed or relapsed after prior standard platinum-based chemotherapy.2. To evaluate the safety of HS-20093 combined with adebrelimab versus docetaxel in patients with driver gene-negative advanced or metastatic nsq-NSCLC who have progressed or relapsed after prior standard platinum-based chemotherapy.# Exploratory Objectives:1. To evaluate the pharmacokinetic (PK) profile of HS-20093 combined with adebrelimab in patients with driver gene-negative advanced or metastatic nsq-NSCLC who have progressed or relapsed after prior standard platinum-based chemotherapy.2. To evaluate the immunogenicity of HS-20093 combined with adebrelimab in patients with driver gene-negative advanced or metastatic nsq-NSCLC who have progressed or relapsed after prior standard platinum-based chemotherapy.3. To explore the relationship between PK exposure of HS-20093 for injection and/or adebrelimab and clinical ef药物成份或治疗方案详述：
Description for medicine or protocol of treatment in
detail：
纳入标准：Inclusion criteria排除标准：
1. 既往病理诊断为混合型非小细胞肺癌（例如混合小细胞肺癌和非小细胞肺癌，混合鳞癌和腺癌）或任何转化型非小细胞肺癌（小细胞肺癌转化为非小细胞肺癌）。
2. 接受过或正在进行以下治疗：
(1) 既往使用过或正在使用以B7-H3为靶点的治疗，例如：MGC018、DS-7300a、ABBV-155、BAT8009、Enoblituzumab和Omburtamab等；
(2) 既往使用过或正在使用拓扑异构酶I抑制物类药物的治疗，包括有效荷载为拓扑异构酶I抑制物的抗体偶联药物等，例如：拓扑替康、伊立替康、德曲妥珠单抗、戈沙妥珠单抗、Dato-Dxd（DS-1062）等；
(3) 既往接受过多西他赛单药或与其他药物联合治疗；
(4) 随机前2周内，接受过细胞毒性化疗药物、试验性药物、以抗肿瘤为适应症的中药治疗（药物名单详见附录12.1）或其他抗肿瘤药物（包括分子靶向治疗或生物治疗等）；
(5) 随机前4周内接受大分子抗肿瘤药物治疗（包括免疫治疗，如单克隆抗体类药物和双特异性抗体类药物）；
(6) 随机前2周内曾经接受局部放疗；随机前4周内，接受过超过30%的骨髓照射，或接受过大面积放疗；
(7) 存在需要临床干预的胸腔积液/腹腔积液（不需要引流积液或引流积液后稳定1周以上的患者可以入组）；存在心包积液（研究者评估不需要临床干预的无症状的少量心包积液允许入组）。如引流时局部使用（如胸腔灌注）过抗肿瘤药物，同时需满足随机前洗脱至少5个药物半衰期或21天（以短者计）才可入组；
(8) 随机前7天内，使用过细胞色素P450（CYP）3A4酶、CYP2D6、P-糖蛋白（P-gp）、乳腺癌耐药蛋白（BCRP）、有机阴离子转运多肽（OATP）1B1或OATP1B3的强抑制剂；或研究期间需要继续接受这些药物治疗（药物名单详见附录12.1）；
(9) 正在接受已知可延长QT间期或可能导致尖端扭转性室性心动过速的药物治疗；或研究期间需要继续接受这些药物治疗（药物名单及洗脱时间详见附录12.1）。
3. 存在既往治疗引起的持续性不良反应，且这些不良反应尚未恢复至1级或既往治疗前的基线状态，但脱发、听力损失、白癜风、通过替代治疗稳定的内分泌疾病以及2级神经病变除外；或者研究者在与申办者协商一致后认为这些不良反应对于当前临床研究中参与者对研究干预措施的耐受性没有临床相关性。
4. 未经治疗的脑转移；脑转移未控制（除非无症状、肿瘤病灶周围无明显水肿的影像学表现，且在首次给药前至少2周不需要类固醇治疗）；存在脑膜转移或脑干转移；存在脊髓压迫（通过放射影像学检查发现，无论是否有症状）。
5. 其他原发恶性肿瘤病史，除外：已根治的实体瘤，在入选研究之前>=5年无活动并且复发风险极低，如经充分治疗且无疾病复发证据的非黑色素瘤皮肤癌或恶性雀斑样痣；经充分治疗且无疾病复发证据的原位癌，如宫颈原位癌；有明确治疗的非转移性前列腺癌。
6. 存在以下任何心脏检查异常情况：
(1) 存在当前具有临床意义的重要的心律失常或ECG异常的证据（例如，完全性左束支传导阻滞、三度房室传导阻滞、二度房室传导阻滞、PR间期>250 ms）；
(2) 存在导致QT间期延长或心律失常事件的风险因素，例如心力衰竭、难治性低钾血症、先天性长QT综合征、长QT综合征家族史，或正在使用任何可能延长QT间期的合并用药；
(3) 静息状态下的ECG检查得出的经Fridericia校正的QT间期（QTcF）平均值>470 ms，Fridericia公式见附录12.3；
(4) 左心室射血分数<50%。
7. 有严重的、未得到控制的或处于活动期的心脑血管疾病，包括但不限于以下情况：
(1) 随机前6个月内发生过心肌梗死；
(2) 随机前6个月内出现不稳定型心绞痛，且未能通过标准治疗方案控制；
(3) 随机前6个月内出现充血性心力衰竭（纽约心脏协会心功能分级II级或以上的充血性心力衰竭[纽约心脏协会标准委员会，1994]）；
(4) 随机前6个月内发生过脑血管意外（中风）或短暂性脑缺血发作；
(5) 有临床意义（由研究者判断）的房性心律失常病史，且未能通过标准治疗方案控制；
(6) 有临床意义（由研究者判断）的室性心律失常病史，或在筛选期间发生任何具有临床意义的室性心律失常。
8. 患有严重或控制不佳的高血压，包括但并不限于：有高血压危象、高血压脑病病史；因血压控制不佳而在随机前2周内调整降压药物。血压控制不佳定义为：在筛选期间收缩压>=180 mmHg或舒张压>=110 mmHg。
9. 严重或控制不佳的糖尿病，包括但不限于：①随机前6个月内发生过糖尿病酮症酸中毒或高血糖高渗状态；或②研究者认为存在其他严重或控制不佳的糖尿病情况。
10. 随机前4周内有严重感染，包括但不限于使用静脉注射抗生素治疗>=2周的感染性并发症、菌血症、重症肺炎；随机前2周内正在接受治疗性静脉注射抗生素的活动性感染。接受或曾接受预防性抗生素治疗的参与者（例如，预防尿路感染）允许入组。
11. 随机前1个月内有临床显著的出血症状或显著的出血倾向。
12. 随机前3个月内发生过严重的动脉或静脉血栓栓塞事件（例如深静脉血栓、肺栓塞等），但植入式静脉输液港相关血栓、导管相关血栓或浅静脉血栓除外（这些不被视为“严重”的血栓栓塞事件）。
13. 已知或可疑有间质性肺炎、免疫性肺炎或放射性肺炎病史；筛选期患有或疑似存在间质性肺炎、免疫性肺炎或放射性肺炎；或随机前存在其他可能会干扰药物相关肺毒性的检测或处理的、严重影响呼吸功能的中重度肺部疾病，包括但不限于特发性肺组织纤维化、机化性肺炎/闭塞性细支气管炎、筛选期肺功能检测结果为中度或重度通气功能障碍。
14. 患有活动性或存在病史且有可能复发的自身免疫性疾病的参与者（如系统性红斑狼疮、类风湿性关节炎、炎症性肠病、自身免疫性甲状腺疾病、多发性硬化、血管炎、肾小球炎等），或高风险（如接受过器官移植需要接受免疫抑制治疗）的患者。但允许患以下疾病的参与者入组：
(1) 采用固定剂量的胰岛素后病情稳定的I型糖尿病患者；
(2) 只需接受激素替代治疗的自身免疫性甲状腺功能减退症；
(3) 无需进行全身治疗的皮肤疾病（如湿疹、占体表10%以下的皮疹、无眼科症状的银屑病等）。需要支气管扩张剂进行医学干预的哮喘者不能纳入。
15. 既往发生过严重或危及生命的免疫介导不良事件（包括免疫药物治疗期间导致永久停药的不良事件）。
16. 具有任意以下情况：
(1) 首次给药前2个月内体重指数（BMI）<18.0 kg/m^2或首次给药前2个月内体重下降>=10%；
(2) 严重营养不良，患者当前正在接受静脉高营养治疗，或需住院接受持续静脉输液治疗。若患者在随机前营养状况已得到有效控制且稳定超过28天可以入组。
17. 现患肝性脑病、肝肾综合征或>=Child-Pugh B级肝硬化。
18. 存在任何活动性肾脏疾病（例如感染、需要透析，或任何其他可能影响参与者安全的肾脏疾病）。注意：允许通过支架成功管理的肾梗阻。
19. 在随机前30天内已接受连续糖皮质激素治疗超过30天、或需要长期（>=30天）使用糖皮质激素治疗者（皮肤外用激素类药品的患者以及使用低剂量皮质类固醇作为肾上腺皮质功能减退替代治疗的患者除外），或患有其他获得性、先天性免疫缺陷疾病，或有移植史（角膜移植除外）。允许按生理替代剂量使用全身性糖皮质激素（<=10 mg/d泼尼松或其等效药物）。
20. 在首次给药前4周内接受过任何重大手术（开颅、开胸或开腹手术）。外科大手术定义参照《医疗技术临床应用管理办法》中规定的3级和4级手术。
21. 既往有严重过敏史者（例如过敏性休克），或曾发生过严重的输液反应，或对重组人源或鼠源蛋白类物质过敏。已知对研究药物（HS-20093、阿得贝利单抗、多西他赛或其他含聚山梨酯-80制剂）的任何成分或辅料存在过敏反应这些情况禁止其参与本研究。
22. 在随机前30天内接受过任何活疫苗。通过适当监管机制（例如紧急使用授权、有条件市场授权或许可证申请）授权的COVID-19疫苗接种不被排除。注意：mRNA和基于腺病毒的COVID-19疫苗被视为非活疫苗。
23. 目前正在入组或参与任何涉及研究性干预措施或其他类型干预性医学研究的其他临床研究。允许参与不涉及研究用药品给药的研究随访部分、非干预性注册研究或流行病学研究。
24. 存在任何严重和/或不稳定的医学或精神疾病或其他状况（包括实验室检查异常），可能会干扰知情同意的获取、对研究程序的依从性，影响对结果的解释，或可能使参与者接受研究药物处于高安全性风险。Exclusion criteria：
1. Prior pathological diagnosis of mixed non-small cell lung cancer (e.g., combined small cell and non-small cell lung cancer, combined squamous cell carcinoma and adenocarcinoma) or any transformed non-small cell lung cancer (transformation from small cell lung cancer to non-small cell lung cancer).
2. Has received or is currently receiving any of the following therapies:
(1) Prior or current use of B7-H3-targeted therapies, such as MGC018, DS-7300a, ABBV-155, BAT8009, Enoblituzumab, Omburtamab, etc.;
(2) Prior or current use of topoisomerase I inhibitors, including antibody-drug conjugates bearing a topoisomerase I inhibitor payload, such as topotecan, irinotecan, trastuzumab deruxtecan, sacituzumab govitecan, Dato-Dxd (DS-1062), etc.;
(3) Prior treatment with docetaxel alone or in combination with other agents;
(4) Receipt of cytotoxic chemotherapy, investigational medicinal products, anticancer traditional Chinese medicines (see Appendix 12.1 for list), or other anticancer agents (including molecular targeted therapy or biologic therapy, etc.) within 2 weeks before randomization;
(5) Receipt of macromolecular anticancer agents (including immunotherapy such as monoclonal antibodies and bispecific antibodies) within 4 weeks before randomization;
(6) Receipt of local radiotherapy within 2 weeks before randomization; receipt of radiotherapy to more than 30% of bone marrow or extensive-field radiotherapy within 4 weeks before randomization;
(7) Presence of pleural effusion/ascites requiring clinical intervention (patients with no need for drainage or stable effusion for >=1 week after drainage may be enrolled); presence of pericardial effusion (asymptomatic small-volume pericardial effusion not requiring clinical intervention per investigator assessment is permitted). If anticancer agents were administered locally (e.g., intrapleural infusion) at the time of drainage, a washout period of at least 5 drug half-lives or 21 days (whichever is shorter) before randomization.
3. Has persistent adverse reactions resulting from prior therapy that have not recovered to Grade 1 or baseline status before previous treatment, excluding alopecia, hearing loss, vitiligo, endocrine diseases stabilized by replacement therapy, and Grade 2 neuropathy; or such adverse reactions are deemed by the investigator, in agreement with the Sponsor, to have no clinical relevance to the participant's tolerance to the study intervention in the current clinical trial.
4. Untreated brain metastases; Uncontrolled brain metastases (except for asymptomatic metastases with no significant perilesional edema on imaging and no requirement for corticosteroid therapy for at least 2 weeks prior to the first dose); Presence of leptomeningeal metastases or brainstem metastases; Presence of spinal cord compression (detected by radiologic imaging, regardless of symptoms).
5. History of other primary malignant tumors, excluding: Radically cured solid tumors with no evidence of disease activity for >=5 years prior to study enrollment and extremely low risk of recurrence; adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease recurrence; adequately treated carcinoma in situ (e.g., cervical carcinoma in situ) with no evidence of disease recurrence; non-metastatic prostate cancer with definitive treatment.
6. Has any of the following cardiac abnormalities:
(1) Evidence of clinically significant cardiac arrhythmia or ECG abnormality (e.g., complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, PR interval > 250 ms);
(2) Risk factors for QT interval prolongation or arrhythmic events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or concurrent use of any medication known to prolong the QT interval;
(3) Mean Fridericia-corrected QT interval (QTcF) on resting ECG > 470 ms (Fridericia formula is provided in Appendix 12.3);
(4) Left ventricular ejection fraction < 50%.
7. Has severe, uncontrolled or active cardiovascular and cerebrovascular diseases, including but not limited to:
(1) Myocardial infarction within 6 months prior to randomization;
(2) Unstable angina within 6 months prior to randomization that is not controlled by standard therapy;
(3) Congestive heart failure (NYHA Class II or higher, NYHA Standards Committee, 1994) within 6 months prior to randomization;
(4) Cerebrovascular accident (stroke) or transient ischemic attack within 6 months prior to randomization;
(5) History of clinically significant atrial arrhythmia (as determined by the investigator) not controlled by standard therapy;
(6) History of clinically significant ventricular arrhythmia (as determined by the investigator), or any clinically significant ventricular arrhythmia occurring during screening.
8. Has severe or poorly controlled hypertension, including but not limited to: history of hypertensive crisis or hypertensive encephalopathy; adjustment of antihypertensive medications within 2 weeks prior to randomization due to inadequate blood pressure control. Poorly controlled hypertension is defined as systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 110 mmHg during screening.
9. Has severe or poorly controlled diabetes mellitus, including but not limited to: ① Diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to randomization; or ② other severe or poorly controlled diabetic conditions as judged by the investigator.
10. Has had a severe infection within 4 weeks prior to randomization, including but not limited to infectious complications requiring intravenous antibiotics for >= 2 weeks, bacteremia, severe pneumonia; has an active infection being treated with therapeutic intravenous antibiotics within 2 weeks prior to randomization. Participants receiving or having received prophylactic antibiotics (e.g., for urinary tract infection prophylaxis) are eligible for enrollment.
11. Has clinically significant bleeding symptoms or marked bleeding tendency within 1 month prior to randomization.
12. Has experienced a severe arterial or venous thromboembolic event (e.g., deep vein thrombosis, pulmonary embolism, etc.) within 3 months prior to randomization, excluding thrombosis related to implantable venous access ports, catheter-related thrombosis, or superficial vein thrombosis (these are not considered "severe" thromboembolic events).
13. Known or suspected history of interstitial pneumonia, immune pneumonitis, or radiation pneumonitis; presence or suspicion of interstitial pneumonia, immune pneumonitis, or radiation pneumonitis during screening; or moderate to severe pulmonary disease within 3 months prior to randomization that may interfere with the evaluation or management of drug-related pulmonary toxicity and severely impair respiratory function, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/bronchiolitis obliterans, and moderate or severe ventilatory dysfunction on pulmonary function tests during screening.
14. Participants with active or history of potentially relapsing autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or patients at high risk (e.g., organ transplant recipients requiring immunosuppressive therapy). However, the following participants are eligible for enrollment:
(1) Type 1 diabetes mellitus stabilized on fixed-dose insulin;
(2) Autoimmune hypothyroidism requiring only hormone replacement therapy;
(3) Skin diseases not requiring systemic therapy (e.g., eczema, rash involving < 10% of body surface area, psoriasis without ocular manifestations, etc.). Asthma requiring medical intervention with bronchodilators is not eligible for enrollment.
15. History of severe or life-threatening immune-mediated adverse events (including adverse events leading to permanent discontinuation of immunotherapy).
16. Has any of the following conditions:
(1) Body mass index (BMI) < 18.0 kg/m^2 within 2 months prior to the first dose, or weight loss >= 10% within 2 months prior to the first dose.
(2) Severe malnutrition with current intravenous hyperalimentation, or requirement for hospitalization and continuous intravenous infusion therapy. Patients may be enrolled if their nutritional status has been effectively controlled and stable for more than 28 days prior to randomization.
17. Has current hepatic encephalopathy, hepatorenal syndrome, or cirrhosis of Child-Pugh Grade B or higher.
18. Has any active renal disease (e.g., infection, requirement for dialysis, or any other renal disease that may compromise participant safety). Note: Renal obstruction successfully managed with stenting is permitted.
19. Has received continuous glucocorticoid therapy for more than 30 days within 30 days prior to randomization, or requires long-term (>=30 days) glucocorticoid therapy (excluding patients on topical corticosteroids for skin disorders and those receiving low-dose corticosteroids as replacement therapy for adrenal insufficiency), or has other acquired or congenital immunodeficiency diseases, or a history of organ transplantation (excluding corneal transplantation). Use of systemic glucocorticoids at physiological replacement doses (<=10 mg/day prednisone or equivalent) is permitted.
20. Has undergone any major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose. Major surgery is defined as Grade 3 and Grade 4 procedures as specified in the Measures for the Administration of Clinical Application of Medical Technologies.
21. Individuals with a history of severe allergies (e.g., anaphylactic shock), or who have experienced severe infusion reactions, or who are allergic to recombinant human or murine proteins are prohibited from participating in this study. Known hypersensitivity to any component or excipient of the investigational products (HS-20093, adebrelimab, docetaxel, or other formulations containing polysorbate 80) also precludes study participation.
22. Has received any live attenuated vaccine within 30 days prior to randomization. COVID-19 vaccines authorized through appropriate regulatory mechanisms (e.g., emergency use authorization, conditional marketing authorization, or license application) are not excluded. Note: mRNA and adenovirus-based COVID-19 vaccines are considered non-live vaccines.
23. Is currently enrolling in or participating in any other clinical trial involving investigational interventions or other interventional medical studies. Participation in the follow-up phase of studies without administration of investigational products, non-interventional registry studies, or epidemiological studies is permitted.
24. Has any severe and/or unstable medical or psychiatric disorder, or other conditions (including abnormal laboratory findings) that may interfere with the provision of informed consent, compliance with study procedures, interpretation of study outcomes, or may expose participants to significant safety risks associated with study drug administration.研究实施时间：
Study execute time：
从
From
2026-04-30 00:00:00至
To
2030-12-01 00:00:00
征募观察对象时间：
Recruiting time：
从
From
2026-04-30 00:00:00
至
To
2027-12-31 00:00:00干预措施：
Interventions：
组别：
对照组
样本量：
225
Group：
control group
Sample size：
干预措施：
多西他赛治疗
干预措施代码：
Intervention：
docetaxel therapy
Intervention code：
组别：
试验组
样本量：
225
Group：
experimental group
Sample size：
干预措施：
HS-20093联合阿得贝利单抗治疗
干预措施代码：
Intervention：
HS-20093 in combination with adebrelimab
Intervention code：研究实施地点：
Countries of recruitment and research settings：
国家：
中国
省(直辖市)：
湖南省
市(区县)：
Country：
China
Province：
Hunan
City：
单位(医院)：
湖南省肿瘤医院
单位级别：
三级甲等
Institution
hospital：
Hunan Cancer Hospital
Level of the institution：
Tertiary A测量指标：
Outcomes：
指标中文名：
探索性指标：暴露水平指标和临床终点（疗效和安全性） 之间的关系
指标类型：
次要指标
Outcome：
Exploratory endpoints: Relationship between exposure metrics and clinical endpoints (efficacy and safety)
Type：
Secondary indicator
测量时间点：
从知情开始到受试者完成研究期间
测量方法：
分层评估肿瘤组织中B7-H3的表达水平和PD-L1表达水平及基线sB7-H3浓度水平的相关性。
Measure time point of outcome：
From the time of informed consent until the subject completes the study
Measure method：
Stratified assessment of the correlations between B7-H3 expression level, PD-L1 expression level in tumor tissue, and baseline sB7-H3 concentration level.
指标中文名：
AE和SAE发生率及严重程度
指标类型：
次要指标
Outcome：
Incidence and severity of AEs and SAEs
Type：
Secondary indicator
测量时间点：
从知情开始到受试者完成研究期间
测量方法：
基于安全集对AE、实验室指标数据、生命体征数据和心电图数据等进行描述性统计汇总和列表。试验组开始治疗直到末次治疗后90天和对照组开始治疗直到末次治疗后30天发生的AE将在安全评价中进行总结。
Measure time point of outcome：
From the time of informed consent until the subject completes the study
Measure method：
Descriptive statistics and tabulations of AEs, laboratory data, vital signs, and ECG data will be performed based on the Safety Set (SS).AEs occurring from the start of treatment up to 90 days after the last dose in the experimental group, and up to 30 days after the last dose in the control group will be summarized in the safety evaluation.
指标中文名：
盲态独立中心阅片（BICR）根据实体瘤疗效 评价标准（RECIST）v1.1标准评估的PFS
指标类型：
主要指标
Outcome：
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Type：
Primary indicator
测量时间点：
从知情开始到受试者完成研究期间
测量方法：
对于BICR评估的PFS，拟采用基于随机分层因素的分层log-rank法进行检验，比较试验组和对照组的PFS是否存在统计学差异，并计算p值。将采用Kaplan-Meier 法绘制生存曲线图并计算mPFS 及其95%置信区间（ CI ）（Brookmeyer-Crowley法），将基于Greenwood’s标准误估计方法，估计6、12和18个月的PFS率及其95%CI。将采用基于随机分层因素校正的C
Measure time point of outcome：
From the time of informed consent until the subject completes the study
Measure method：
For PFS assessed by BICR, the stratified log-rank test adjusted for randomization stratification factors will be used to compare the statistical difference in PFS between the experimental group and the control group, with p-values calculated.
The Kaplan?Meier method will be used to plot survival curves and estimate the median PFS (mPFS) along with its 95% confidence interval (CI) using the Brookmeyer?Crowley method. The 6?, 12?, and 18?month PFS rates and their 95% CIs will be estimated based o
指标中文名：
探索性指标：抗HS-20093 抗体， 抗阿得贝利单抗抗体 （ADA）的阳性患者比例
指标类型：
次要指标
Outcome：
Exploratory endpoint: Proportion of patients positive for anti-HS-20093 antibodies and anti-adebrelimab antibodies (ADA)
Type：
Secondary indicator
测量时间点：
从知情开始到受试者完成研究期间
测量方法：
本研究将对免疫原性样本进行抗HS-20093抗体和抗阿得贝利单抗抗体（ADA）检测，评估ADA对药物PK、安全性及疗效造成的影响。
Measure time point of outcome：
From the time of informed consent until the subject completes the study
Measure method：
In this study, immunogenicity samples will be tested for anti-HS-20093 antibodies and anti-adebrelimab antibodies (ADA),to evaluate the impact of ADA on the pharmacokinetics (PK), safety, and efficacy of the study drugs.
指标中文名：
探索性指标：探索B7-H3、细胞程序性死亡-配体1（PDL1） 的表达水平及sB7-H3浓度水平和疗效的相关性
指标类型：
次要指标
Outcome：
Exploratory endpoint: Exploration of the correlations between expression levels of B7-H3 and programmed cell death ligand 1 (PD-L1), sB7-H3 concentration levels, and efficacy.
Type：
Secondary indicator
测量时间点：
从知情开始到受试者完成研究期间
测量方法：
1. 通过对biomarker进行分层，评估B7-H3、PD-L1蛋白不同表达水平与HS-20093疗效（ORR、PFS、OS）之间的关系。 2. 通过对biomarker进行分层，评估基线sB7-H3浓度水平和HS-20093疗效（ORR、PFS、OS）的相关性。
Measure time point of outcome：
From the time of informed consent until the subject completes the study
Measure method：
1. Stratified analyses by biomarkers will be performed to evaluate the relationship between different expression levels of B7-H3 and PD-L1 proteins and the efficacy of HS-20093 (ORR, PFS, OS). 2. Stratified analyses by biomarkers will be performed to evaluate the correlation between baseline sB7-H3 concentration levels and the efficacy of HS-20093 (ORR, PFS, OS).
指标中文名：
探索性指标：HS-20093和阿得贝利单抗PK特征：峰浓度 （Cmax），达峰时间（Tmax），血药浓度-时 间曲线下面积（AUC）等
指标类型：
次要指标
Outcome：
Exploratory endpoint: Pharmacokinetic (PK) profiles of HS-20093 and adebrelimab, including peak concentration (Cmax), time to peak concentration (Tmax), area under the plasma concentration-time curve
Type：
Secondary indicator
测量时间点：
从知情开始到受试者完成研究期间
测量方法：
根据多次检测的HS-20093（包括HS-20093、总抗和小分子毒素）和阿得贝利单抗的血药浓度数据，将采用非线性混合效应动力学方法进行群体药代动力学（PopPK）和暴露-响应（E-R）关系分析，评价PK变异、内因和外因对PK的影响，以及E-R（疗效和安全性）的关系等，PK和E-R分析结果将单独报告。
Measure time point of outcome：
From the time of informed consent until the subject completes the study
Measure method：
Based on repeatedly measured plasma concentration data of HS-20093 (including HS-20093, total antibody, and small-molecule toxin) and adebrelimab, the nonlinear mixed-effects modeling approach will be used to conduct population pharmacokinetic (PopPK) and exposure-response (E-R) analyses. These analyses will evaluate PK variability, the effects of intrinsic and extrinsic factors on PK, and E-R relationships (efficacy and safety). The results of the PK and E-R analyses will be reported separately
指标中文名：
BICR根据RECIST v1.1标准评估的客观缓解 率（ORR）；疾病控制率（DCR）和缓解持 续时间（DoR）
指标类型：
次要指标
Outcome：
Objective response rate (ORR), disease control rate (DCR), and duration of response (DoR) assessed by BICR per RECIST v1.1
Type：
Secondary indicator
测量时间点：
从知情开始到受试者完成研究期间
测量方法：
BICR/研究者评估的ORR：将采用基于随机分层因素校正的Logistic 回归分析方法，计算两组的比值比（OR）及其95%CI，同时计算p 值。
BICR/研究者评估的DCR：将采用基于随机分层因素校正的Logistic 回归分析方法，计算试验组和对照组的比值比（OR）及其95%CI，同时计算p 值。
BICR/研究者评估的DoR：采用基于随机分层因素校正的分层log-rank 法进行检验，比较
Measure time point of outcome：
From the time of informed consent until the subject completes the study
Measure method：
ORR as assessed by BICR/investigator: Logistic regression adjusted for randomization stratification factors will be used to calculate the odds ratio (OR) and its 95% CI between the two groups, along with the p-value.
DCR as assessed by BICR/investigator: Logistic regression adjusted for randomization stratification factors will be used to calculate the odds ratio (OR) and its 95% CI between the experimental group and the control group, along with the p-value.
DoR as assessed by BICR/investigat
指标中文名：
OS
指标类型：
主要指标
Outcome：
OS
Type：
Primary indicator
测量时间点：
从知情开始到受试者完成研究期间
测量方法：
对于OS，拟采用基于随机分层因素的分层log-rank法进行检验，比较试验组和对照组的OS是否存在统计学差异，并计算p值。将采用Kaplan-Meier法绘制生存曲线图并计算mOS及其95%置信区间（CI）（Brookmeyer-Crowley法），将基于Greenwood’s标准误估计方法，估计12、18和24个月的生存率及其95%CI。将采用基于随机分层因素校正的Cox比例风险模型估计HR及其
Measure time point of outcome：
From the time of informed consent until the subject completes the study
Measure method：
For overall survival (OS), the stratified log?rank test adjusted for randomization stratification factors will be used to compare the statistical difference in OS between the experimental group and the control group, with p?values calculated.
The Kaplan?Meier method will be used to plot survival curves and estimate the median OS (mOS) and its 95% confidence interval (CI) using the Brookmeyer?Crowley method. The 12?, 18?, and 24?month survival rates and their 95% CIs will be estimated based on G
指标中文名：
研究者根据RECIST v1.1标准评估的ORR、 DCR、DoR和PFS
指标类型：
次要指标
Outcome：
ORR, DCR, DoR and PFS assessed by the investigator per RECIST v1.1
Type：
Secondary indicator
测量时间点：
从知情开始到受试者完成研究期间
测量方法：
1. 研究者评估的PFS：在能够满足分析所要求的事件数的前提下，研究者评估的PFS的分析方法和模型同BICR评估的PFS。 2. BICR/研究者评估的ORR：将采用基于随机分层因素校正的Logistic回归分析方法，计算两组的比值比（OR）及其95%CI，同时计算p值。 3. BICR/研究者评估的DCR：将采用基于随机分层因素校正的Logistic回归分析方法，计算试验组和对照组的比值比。
Measure time point of outcome：
From the time of informed consent until the subject completes the study
Measure method：
1. Investigator-assessed PFS: Provided that the number of events required for the analysis is met, the analytical methods and models for investigator-assessed PFS shall be the same as those for BICR-assessed PFS. 2. BICR/investigator-assessed ORR: Logistic regression adjusted for randomization stratification factors will be used to calculate the odds ratio (OR) and its 95% CI between the two groups, together with the p-value. 3. BICR/investigator-assessed DCR: Logistic regression adjusted for ra
指标中文名：
生命体征、实验室检查（ 血常规和血生 化）、心脏功能［心电图（ECG）］和美国 东部肿瘤协作组（ECOG）体力状况（PS） 评分等较基线的变化
指标类型：
次要指标
Outcome：
Changes from baseline in vital signs, laboratory tests (complete blood count and blood biochemistry), cardiac function [electrocardiogram (ECG)], and Eastern Cooperative Oncology Group (ECOG) performa
Type：
Secondary indicator
测量时间点：
从知情开始到受试者完成研究期间
测量方法：
1. 体重、生命体征和实验室检查（如血常规、尿常规、血生化等）中符合计量资料性质的数据，将对基线数据、给药后数据和相对基线变化数据按各次随访和治疗组进行总结；针对定性资料如各项检查的正常与否和有无临床意义，如适用，将以列表形式描述从基线至给药后每次随访的变化。 2. ECG：采用均数、标准差、最大值、最小值、中位数描述治疗前后的心率、PR间期、QT间期、QTcF间期的测量值和较基线变化值。总结治疗。
Measure time point of outcome：
From the time of informed consent until the subject completes the study
Measure method：
1. For quantitative data including body weight, vital signs, and laboratory tests (such as complete blood count, urinalysis, blood biochemistry, etc.), baseline data, post-dose data, and changes from baseline will be summarized by each follow-up visit and treatment group. For qualitative data, such as normal/abnormal status and clinical significance of test results, changes from baseline to each post-dose follow-up visit will be described in tabular form if applicable. 2. ECG: The mean, standard采集人体标本：
Collecting sample(s)
from participants：
标本中文名：
PK/ADA/sB7-H3血样
组织：
Sample Name：
PK/ADA/sB7-H3 blood samples
Tissue：
人体标本去向
其它
说明
Fate of sample：
0thers
Note：
标本中文名：
肿瘤组织切片
组织：
Sample Name：
Tumor tissue sections
Tissue：
人体标本去向
其它
说明
Fate of sample：
0thers
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
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）：
本试验采用网络交互应答系统（IWRS）对参与者进行随机化入组。随机化方法为分层区组随机。随机分层因素包括：
1. 入组时的基线脑转移情况（有；无）；
2. 基线ECOG PS评分（0；1）；
3. 基线肿瘤组织PD-L1表达情况（TPS<1%；TPS>=1%）。
按照1:1的比例将参与者随机分配至试验组（HS-20093联合阿得贝利单抗）和对照组（多西他赛）。如果参与者退出研究，则IWRS所分配的参与者随机号。Randomization Procedure (please state who
generates the
random number sequence and by what method)：
In this trial, participants were randomized using an Interactive Web Response System (IWRS). The randomization method was stratified block randomization. Stratification factors included:
1. Baseline brain metastasis at enrollment (present; absent)
2. Baseline ECOG PS score (0; 1)
3. Baseline tumor PD-L1 expression (TPS < 1%; TPS >= 1%)
Participants were randomized in a 1:1 ratio to either the experimental group (HS-20093 plus adebrelimab) or the control group (docetaxel). If a participant withdrew from the study, the randomization number assigned by the IWRS.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：
开放标签Blinding：
Open-label study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）：
不共享原始数据The way of sharing IPD”(include metadata and
protocol,
If use web-based public database, please provide
the
url)：
No sharing of raw data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：
1.病例记录表（CRF）；2.电子采集和管理系统（EDC）Data collection and Management (A
standard data collection and management system
include a CRF and an electronic data capture：
1. Case Report Form (CRF)；2. Electronic Data Capture and Management System (EDC)数据与安全监察委员会：
Data and Safety Monitoring Committee：
有/Yes注册人：
Name of Registration：
2026-04-28 10:32:22
