芦康沙妥珠单抗(Sacituzumab tirumotecan) - 药物靶点：Top I x Trop-2_在研适应症：EGFR阳性非鳞状非小细胞肺癌，三阴性乳腺癌，EGFR突变的非小细胞肺癌_专利_临床

概要

基本信息

药物类型

ADC

别名

Sac-TMT、TROP-2-targeted antibody-drug conjugate、A-264

+ [7]

靶点

Top I x Trop-2

作用方式

抑制剂

作用机制

TOP1抑制剂(DNA拓扑异构酶I抑制剂)、Trop-2抑制剂(肿瘤相关钙信号传感器2抑制剂)

治疗领域

肿瘤皮肤和肌肉骨骼疾病呼吸系统疾病+ [4]

在研适应症

EGFR阳性非鳞状非小细胞肺癌三阴性乳腺癌EGFR突变的非小细胞肺癌+ [52]

非在研适应症-

原研机构

四川科伦药业股份有限公司

在研机构

默沙东研发（中国）有限公司Merck Sharp & Dohme LLC

KLUS Pharma, Inc.

+ [3]

非在研机构-

权益机构

四川科伦博泰生物医药股份有限公司

Merck Sharp & Dohme Corp.

最高研发阶段批准上市

首次获批日期

中国 (2024-11-22),

三阴性乳腺癌

最高研发阶段(中国)批准上市

特殊审评优先审评 (中国)、突破性疗法 (中国)、附条件批准 (中国)、突破性疗法 (美国)

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结构/序列

使用我们的ADC技术数据为新药研发加速。

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Sequence Code 27958L

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Sequence Code 319372635H

来源: *****

关联

58

项与芦康沙妥珠单抗相关的临床试验

NCT06966700

/ Not yet recruiting临床3期

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer

Researchers are looking for new ways to treat types of breast cancer that are both:
* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment
* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.
Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.
The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:
* Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy
* Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

开始日期2025-06-19

申办/合作机构

Merck Sharp & Dohme LLC

NCT06952504

/ Not yet recruiting临床3期

A Phase 3 Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan in Combination With Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (TroFuse-033/GOG-3119/ENGOT-en29)

Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent.
* EC is a type of cancer that starts in the tissues inside the uterus (womb)
* pMMR indicates that certain normal proteins are present in the cancer cells
* Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery
* Recurrent means the cancer came back after surgery
Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells.
The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone.

开始日期2025-05-23

申办/合作机构

Merck Sharp & Dohme LLC

NCT06824467

/ Recruiting临床3期

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)

The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and If people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.

开始日期2025-04-09

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

100 项与芦康沙妥珠单抗相关的临床结果

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100 项与芦康沙妥珠单抗相关的转化医学

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100 项与芦康沙妥珠单抗相关的专利（医药）

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6

项与芦康沙妥珠单抗相关的文献（医药）

1999-07-15·Blood1区 · 医学

Fibrinogen Receptor Antagonist-Induced Thrombocytopenia in Chimpanzee and Rhesus Monkey Associated With Preexisting Drug-Dependent Antibodies to Platelet Glycoprotein IIb/IIIa

1区 · 医学

Article

作者: Bednar, Bohumil ; Holahan, Marie A. ; Hartman, George D. ; Gould, Robert J. ; Cook, Jacquelynn J. ; Cunningham, Michael E. ; Jumes, Patricia A. ; Bednar, Rodney A.

Most clinical trials with fibrinogen receptor antagonists (FRAs) have been associated with thrombocytopenia. This report describes the occurrence of thrombocytopenia in one chimpanzee and one rhesus monkey upon administration of potent FRAs. Chimpanzee A-264 experienced profound thrombocytopenia on two occasions immediately upon intravenous administration of two different potent FRAs, L-738,167 and L-739,758. However, an equally efficacious antiaggregatory dose of another potent antagonist, L-734,217, caused no change in platelet count. These compounds did not affect platelet count in five other chimpanzees or numerous other nonhuman primates. Flow cytometric analysis showed drug-dependent antibodies (DDAbs) in the plasma of chimpanzee A-264 that bound to platelets of chimpanzees, humans, and all other primates tested only in the presence of the compounds that induced thrombocytopenia. Rhesus monkey 94-R021 experienced thrombocytopenia upon administration of a different antagonist, L-767,679, and several prodrugs that are converted into the active form, L-767,679, in the blood. More than 20 other FRAs, including those that induced thrombocytopenia in chimpanzee A-264, had no effect on platelet count in this monkey. Flow cytometric measurements again identified DDAbs that reacted with platelets of all primates tested and required the presence of L-767,679. Screening for DDAbs in the plasma of 1,032 human subjects with L-738,167 and L-739,758 demonstrated that the incidence of these preexisting antibodies in this population was 0.8% ± 0.6% and 1.1% ± 0.6%, respectively.

Frontiers in oncology

Preclinical profiles of SKB264, a novel anti-TROP2 antibody conjugated to topoisomerase inhibitor, demonstrated promising antitumor efficacy compared to IMMU-132

Article

作者: Xie, Jia ; Chen, Yang ; Zhao, Xi ; Long, Hu ; Ji, Yafei ; Pu, Yuzhi ; Xu, Mingyu ; Tan, Yuping ; Song, Hongmei ; Cheng, Yezhe ; Tian, Qiang ; Yuan, Xiaoxi ; Huang, Xiuying

Purpose:

The aim of this study was to improve the intratumoral accumulation of an antibody–drug conjugate (ADC) and minimize its off-target toxicity, SKB264, a novel anti-trophoblast antigen 2 (TROP2) ADC that was developed using 2-methylsulfonyl pyrimidine as the linker to conjugate its payload (KL610023), a belotecan-derivative topoisomerase I inhibitor. The preclinical pharmacologic profiles of SKB264 were assessed in this study.

Methods:

The in vitro and in vivo pharmacologic profiles of SKB264, including efficacy, pharmacokinetics–pharmacodynamics (PK-PD), safety, and tissue distribution, were investigated using TROP2-positive cell lines, cell-derived xenograft (CDX), patient-derived xenograft (PDX) models, and cynomolgus monkeys. Moreover, some profiles were compared with IMMU-132.

Results:

In vitro, SKB264 and SKB264 monoclonal antibody (mAb) had similar internalization abilities and binding affinities to TROP2. After cellular internalization, KL610023 was released and inhibited tumor cell survival. In vivo, SKB264 significantly inhibited tumor growth in a dose-dependent manner in both CDX and PDX models. After SKB264 administration, the serum or plasma concentration/exposure of SKB264 (conjugated ADC, number of payload units ≥1), total antibody (Tab, unconjugated and conjugated mAb regardless of the number of the payload units), and KL610023 in cynomolgus monkeys increased proportionally with increasing dosage from 1 to 10 mg/kg. The linker stability of SKB264 was significantly enhanced as shown by prolonged payload half-life in vivo (SKB264 vs. IMMU-132, 56.3 h vs. 15.5 h). At the same dose, SKB264’s exposure in tumor tissue was 4.6-fold higher than that of IMMU-132.

Conclusions:

Compared with IMMU-132, the longer half-life of SKB264 had a stronger targeting effect and better antitumor activity, suggesting the better therapeutic potential of SKB264 for treating TROP2-positive tumors.

Experimental Hematology & Oncology

Antibody-drug conjugates in breast cancer: current evidence and future directions

Review

作者: Li, Na ; Du, Tian ; Zhao, Zixuan ; Li, Ning ; Liang, Gehao ; Tang, Jun ; Yang, Lu

Abstract:

Antibody-drug conjugates (ADCs) are a rapidly evolving class of antitumor drugs and have already revolutionized the treatment strategy of many hematologic and solid cancers. So far, trastuzumab emtansine (T-DM1), trastuzumab deruxtecan (T-DXd), sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) are the four ADCs that have been approved by US food and drug administration (FDA) in treatment of breast cancer, and SKB264 has been approved by Chinese national medical products administration (NMPA). Many ADCs for treatment of breast cancer are currently being tested in late-phase clinical trials, with several encouraging results achieved recently. However, major issues arise during the use of ADCs, including emergence of acquired resistance, occurrence of treated-related toxicities, and identification of biomarkers of response and resistance. ADCs are being increasingly tested in combination with other agents, and novel next-generation ADC development is progressing rapidly. A better understanding of the design and development of ADCs will promote ADC development for cancer treatment. In this review, we aim to provide a broad overview of the design and the recent advances of ADCs in breast cancer. We also propose several notable future directions of ADCs in treatment of breast cancer.

665

项与芦康沙妥珠单抗相关的新闻（医药）

2025-05-22

·药渡Daily

HR+/HER2-乳腺癌，科伦博泰TROP2 ADC芦康沙妥珠单抗第4个NDA获受理

5月22日，科伦博泰宣布其TROP2 ADC芦康沙妥珠单抗（sac-TMT，亦称SKB264/MK-2870）的一项sNDA已获得CDE受理，用于治疗既往接受过内分泌治疗且在晚期或转移性阶段接受过其他系统治疗的不可切除的局部晚期或转移性HR+/HER2-乳腺癌成人患者。HR+/HER2-乳腺癌是最常见的亚型，约占全部乳腺癌病例的70%。这类患者由于常为激素敏感型人群，首选方案为内分泌治疗+CDK4/6抑制剂；对于耐药或无最佳内分泌治疗的晚期患者来说，首选解救化疗。然而若是对上述疗法都失败，当前可供选择非常有限。本次受理是基于OptiTROP-Breast02注册III期研究的积极结果。该试验中，评估了芦康沙妥珠单抗单一疗法（5mg/kg每两周一次(Q2W)）vs研究者选择化疗方案用于治疗局部晚期或转移性HR+/HER2-乳腺癌患者的有效性和安全性。根据预设的期中分析，该III期临床研究达到主要疗效终点，与研究者选择化疗方案相比，芦康沙妥珠单抗在主要终点由BIRC评估的PFS方面具有显著统计学意义和临床意义的改善，显著降低疾病进展或死亡风险，并显示出OS获益趋势。先前5月16日，该申请拟纳入CDE的优先审评审批程序。根据药渡数据库，目前芦康沙妥珠单抗已有2项适应症在中国获批上市，分别为用于治疗既往接受过≥2种系统治疗的不可切除局部晚期或转移性三阴性乳腺癌；经EGFR-TKI和含铂化疗治疗后进展的EGFR+的局部晚期或转移性非鳞状非小细胞肺癌。此外，芦康沙妥珠单抗用于治疗经EGFR-TKI治疗后进展的EGFR+局部晚期或转移性非小细胞肺癌的新增适应症上市申请已获CDE受理，并被纳入优先审评审批程序。2022年5月，科伦博泰授予默沙东在大中华区以外的所有地区开发、使用、制造及商业化芦康沙妥珠单抗的独家权利。截止目前，科伦博泰已在中国开展8项注册性临床研究。默沙东已启动14项正在进行的芦康沙妥珠单抗作为单药疗法或联合帕博利珠单抗或其他药物用于多种类型癌症的全球性III期临床研究（这些研究由默沙东申办并主导）。参考资料科伦博泰官微

优先审批临床3期申请上市抗体药物偶联物

2025-05-22

·药圈头条

科伦博泰「芦康沙妥珠单抗」第4项适应症申报上市

今日（5月22日），科伦博泰发布公告，其Trop2 ADC新药芦康沙妥珠单抗（sac-TMT，佳泰莱®）的一项新增适应症上市申请已获CDE受理，用于治疗既往接受过内分泌治疗且在晚期或转移性阶段接受过其他系统治疗的不可切除的局部晚期或转移性激素受体阳性(HR+)且人表皮生长因子受体2阴性（HER2-）乳腺癌(BC)成人患者。本次受理是基于OptiTROP-Breast02注册3期研究的积极结果。该申请是芦康沙妥珠单抗（sac-TMT）获NMPA受理的第四个适应症上市申请。OptiTROP-Breast02是一项随机、开放标签、多中心3期临床研究，评估芦康沙妥珠单抗(sac-TMT)单一疗法(5mg/kg每两周一次(Q2W))对比研究者选择化疗方案用于治疗局部晚期或转移性HR+/HER2-(免疫组织化学[IHC]0、IHC1+或IHC2+/原位杂交[ISH]-)BC患者的有效性和安全性。根据预设的期中分析，该3期临床研究达到主要疗效终点，与研究者选择化疗方案相比，芦康沙妥珠单抗(sac-TMT)单一疗法在主要终点由盲态独立评审委员会(BIRC)评估的无进展生存期(PFS)方面具有显著统计学意义和临床意义的改善，显著降低疾病进展或死亡风险。同时，芦康沙妥珠单抗(sac-TMT)显示出总生存期(OS)获益趋势。作为科伦博泰的核心产品，芦康沙妥珠单抗(sac-TMT)已有2项适应症在中国获批上市，分别为：用于治疗既往至少接受过2种系统治疗（其中至少1种治疗针对晚期或转移性阶段）的不可切除的局部晚期或转移性三阴性乳腺癌(TNBC)用于治疗经表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)和含铂化疗治疗后进展的EGFR突变阳性的局部晚期或转移性非鳞状非小细胞肺癌。2022年5月，科伦博泰授予默沙东(美国新泽西州罗威市默克公司的商号)在大中华区(包括中国内地、香港、澳门及台湾)以外的所有地区开发、使用、制造及商业化芦康沙妥珠单抗(sac-TMT)的独家权利。截至目前，科伦博泰已在中国开展8项注册性临床研究。默沙东已启动14项正在进行的芦康沙妥珠单抗(sac-TMT)作为单药疗法或联合帕博利珠单抗或其他药物用于多种类型癌症的全球性3期临床研究（这些研究由默沙东申办并主导)。

2025-05-22

·医药健闻

美敦力宣布拆分糖尿病业务；三星生物计划拆分生物仿制药业务；赛诺菲收购阿尔茨海默症药物开发商 | 日报

全球医疗行业每日重点资讯文 | 苏丁企业动态医疗设备制造商美敦力(Medtronic)周三宣布，计划将其胰岛素泵及其他可穿戴设备为主的糖尿病业务剥离为独立公司。此次拆分将使美敦力更专注于心脏设备等盈利能力更强的业务板块。新公司将由现任美敦力糖尿病业务总裁Que Dallara执掌，预计将纳入约8000名员工，总部设于加利福尼亚州诺斯里奇市。拆分计划拟在未来18个月内通过资本市场交易完成，优先考虑采用IPO后分拆的方案。美敦力(Medtronic)公布截至2025年4月25日的第四财季和财年业绩。第四财季净销售额89.27亿美元，上年同期为85.89亿美元。季度营业利润14.36亿美元，上年同期为10.53亿美元。季度归属公司的净利润10.57亿美元，上年同期为6.54亿美元。财年净销售额335.37亿美元，上财年为323.64亿美元。财年营业利润59.55亿美元，上财年为51.44亿美元。财年归属公司的净利润46.62亿美元，上年同期为36.76亿美元。韩国制药商三星生物表示，计划将公司拆分为合同制造公司和研发控股公司。三星生物在一份监管文件中表示，将保留其药品合同制造业务，同时剥离包括生物仿制药开发业务，并将仿制药业务注入新成立的研发控股公司。赛诺菲宣布已达成协议，以约4.7亿美元的价格收购Vigil Neuroscience，该交易为其阿尔茨海默症治疗增加了一种新的研究药物，通过纳入Vigil公司治疗阿尔茨海默病的研究药物VG-3927，增强赛诺菲的早期产品线。包括可能的后续支付在内，这笔交易的总股本价值可能达到约6亿美元。赛诺菲表示，这笔交易预计将在今年第三季度完成。BioMarin宣布，将以2.7亿美元的价格收购罕见病专家Inozyme Pharma，以扩大其酶疗法产品组合。BioMarin将为Inozyme的每股流通股支付4美元。两家公司预计将在第三季度完成交易，等待惯例成交条件。该交易的核心是Inozyme的INZ-701，这是一种研究性酶替代疗法，目前处于开发后期阶段，用于治疗外核苷酸焦磷酸酶/磷酸二酯酶1 （ENPP1）缺乏症。从今年开始，礼来公司已拨款270亿美元扩大其在美国的生产足迹，忙于为新的药物成分工厂寻找潜在的地点。根据最近提交给德克萨斯州的一份文件，礼来正在权衡是否在休斯顿建造一座价值59亿美元的活性药物成分（API）制造工厂，该公司正在争夺德克萨斯州的税收减免。如果该提案推进，礼来计划从McCord Development购买休斯顿Generation Park大约236英亩的土地，最终项目将包括多座建筑和户外设施，以及基础设施建设和设备安装。奥林巴斯（Olympus）宣布任命Slawek Kierner为智能互联护理（CDO-SCC）首席数字官，即日起生效。在这个职位上，Slawek将向首席技术官Syed Naveed汇报工作，并将领导奥林巴斯医疗设备与医疗辅助机器人技术、数字技术和人工智能（AI）的整合。他将领导奥林巴斯智能内窥镜生态系统与OLYSENSE平台的开发和扩展，利用数字技术连接传统内窥镜设备、机器人技术和数字解决方案。在加入奥林巴斯前，Slawek曾在直觉公司（Intuitive Inc.）工作。上海交通大学医学院附属瑞金医院闵行院区项目正式启动，预计2028年竣工。该院区位于闵行大零号湾，落成后将是闵行最大的三甲医院。该医院建成的时候，国产（医疗器械）产品的使用率要超过90%，让更多的国产医疗器械，尤其是上海生产的医疗器械在瑞金医院能够使用。瑞金医院闵行院区总建筑面积127350平方米，包括门急诊中心、医疗综合楼、临床研究楼，拟设床位500张，将参照三级综合医院标准进行建设。万东医疗公告，公司董事长胡自强因个人原因辞去董事长等职务，辞职报告自送达董事会之日起生效。胡自强在任职期间未持有公司股份。同日，公司选举马赤兵为新任董事长，任期自董事会审议通过之日起至第十届董事会任期届满之日止。产业动态美国生物技术公司Prime Medicine宣布，先导编辑技术首次用于治疗人类患者。此次开发的先导编辑疗法PM359旨在纠正导致慢性肉芽肿病的基因突变。慢性肉芽肿病是一种危险的疾病，会使包括中性粒细胞在内的多种免疫细胞失去功能。Orionis Biosciences与罗氏（Roche）旗下基因泰克（Genentech）达成第二项多年期合作协议，双方将合作开发用于肿瘤领域的新型小分子单价分子胶药物，这些药物靶向具高挑战性的靶点。根据协议条款，Orionis将负责分子胶的发现与优化工作，而基因泰克将负责后期的临床前与临床开发、监管申报及商业化。Orionis将获得1.05亿美元的预付款，并有资格获得总额可能超过20亿美元的潜在研究、开发、商业化等里程碑款项。罗氏/勃林格殷格翰（BI）的替奈普酶国内获批上市。根据临床试验进展，业内推测用于急性缺血性卒中的溶栓治疗（AIS）。今年3月初，替奈普酶AIS适应症也在美国获批上市，成为近30年来FDA批准的首个中风药物。该产品并不是一款新疗法，2000年就已经在美国上市，用于治疗成人急性ST段抬高型心肌梗死。替奈普酶是一款组织纤溶酶原激活剂、凝块溶解剂和血栓溶解剂，以单次静脉(IV)推注的方式给药，给药时间为五秒钟。诺诚健华靶向CD19的产品坦昔妥单抗（tafasitamab，商品名：明诺凯）联合来那度胺治疗不适合自体干细胞移植条件的复发/难治性弥漫性大B细胞淋巴瘤（r/rDLBCL）成人患者的上市申请获得国家药品监督管理局（NMPA）批准。这是中国首个获批治疗r/rDLBCL的CD19单抗。国家药监局（NMPA）网站显示，正大天晴贝莫苏拜单抗的新适应症上市申请获得批准，用于联合安罗替尼一线治疗晚期不可切除或转移性肾细胞癌（RCC）肾细胞癌患者。科伦药业控股子公司科伦博泰靶向人滋养细胞表面抗原 2(TROP2)的抗体偶联药物(ADC)芦康沙妥珠单抗(sac-TMT，佳泰莱)的一项新增适应症上市申请获中国国家药品监督管理局(NMPA)药品审评中心(CDE)受理，用于治疗既往接受过内分泌治疗且在晚期或转移性阶段接受过其他系统治疗的不可切除的局部晚期或转移性激素受体阳性(HR+)且人表皮生长因子受体2阴性(HER2-)乳腺癌(BC)成人患者。科兴制药全资子公司深圳科兴自主研发的创新药GB18注射液药品临床试验申请已获得美国FDA批准，可在美国开展临床试验。GB18注射液是一种针对GDF15靶点的创新型药物，用于治疗肿瘤恶病质。“南宁惠邕保”公布2025年新一年度的保障详情。其中，阿尔茨海默病的创新药物——仑卡奈单抗，被纳入《2025年尊享版30种特定药品目录》。仑卡奈单抗作为一种治疗阿尔茨海默病的一类创新药物，由卫材和渤健合作开发，国家药品监督管理局于2024年1月批准用于治疗由阿尔茨海默病引起的轻度认知障碍和阿尔茨海默病轻度痴呆。联系美通社+86-10-5953 9500info@prnasia.com

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100 项与芦康沙妥珠单抗相关的药物交易

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研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
EGFR阳性非鳞状非小细胞肺癌	中国	四川科伦博泰生物医药股份有限公司	2025-03-04
三阴性乳腺癌	中国	四川科伦博泰生物医药股份有限公司	2024-11-22

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
EGFR突变的非小细胞肺癌	申请上市	中国	四川科伦博泰生物医药股份有限公司	2024-08-20
激素受体/生长因子受体阴性乳腺癌	临床3期	-	Merck Sharp & Dohme LLC	2025-06-19
HR阳性/HER2阴性小叶癌	临床3期	-	Merck Sharp & Dohme LLC	2025-06-19
HR阳性/HER2低表达乳腺癌	临床3期	-	Merck Sharp & Dohme LLC	2025-06-19
输卵管癌	临床3期	美国	Merck Sharp & Dohme LLC	2025-04-09
输卵管癌	临床3期	日本	Merck Sharp & Dohme LLC	2025-04-09
输卵管癌	临床3期	澳大利亚	Merck Sharp & Dohme LLC	2025-04-09
输卵管癌	临床3期	西班牙	Merck Sharp & Dohme LLC	2025-04-09
输卵管癌	临床3期	中国台湾	Merck Sharp & Dohme LLC	2025-04-09
铂类耐药性原发性腹膜癌	临床3期	美国	Merck Sharp & Dohme LLC	2025-04-09

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05347134 (OptiTROP-Breast01, Pubmed \| Nat Med) 人工标引	临床3期	转移性三阴性乳腺癌二线	263	Sacituzumab tirumotecan (sac-TMT)	鑰鏇夢糧構網簾網鑰鏇(衊願夢襯網築築鬱糧糧) = 蓋糧範淵餘憲範鑰鹹膚網築遞鹹蓋範餘網鏇襯 (憲網鹹願鹽糧觸鹹積築, 5.5 ~ 8.0) 达到更多	积极	2025-04-11
				Chemotherapy	鑰鏇夢糧構網簾網鑰鏇(衊願夢襯網築築鬱糧糧) = 淵夢範顧獵衊餘蓋築餘網築遞鹹蓋範餘網鏇襯 (憲網鹹願鹽糧觸鹹積築, 1.7 ~ 2.7) 达到更多
NCT05631262 \| NCT04152499 (KL264-01, Pubmed \| Nat Med \| NEWS) 人工标引	N/A	晚期非小细胞肺癌	107	Sacituzumab tirumotecan (KL264-01)	夢選醖鹽膚窪觸憲鬱齋(製鹽製淵糧蓋窪壓膚餘) = 衊獵襯鹽顧製壓鏇製願襯襯鹹憲窪鑰獵遞膚構 (鹹鬱蓋糧鏇繭糧餘選艱, 25 ~ 56) 更多	积极	2025-04-10
				Sacituzumab tirumotecan (EGFR-mutant + KL264-01)	夢選醖鹽膚窪觸憲鬱齋(製鹽製淵糧蓋窪壓膚餘) = 鑰積製壓齋選構繭顧夢襯襯鹹憲窪鑰獵遞膚構 (鹹鬱蓋糧鏇繭糧餘選艱 ) 更多
NCT04152499 (MK-2870-001, ASCO_GU2025) 人工标引	临床1/2期	晚期尿路上皮癌末线 \| 三线 \| 二线	49	sac-TMT 5 mg/kg (UC 2L)	糧願鹽衊壓艱構製積選(壓衊觸繭獵製範鬱醖醖) = 鹹餘網醖鹹膚遞選餘觸糧壓夢襯憲醖觸艱顧憲 (憲鑰艱簾廠鑰餘膚顧壓, 16.7 ~ 76.6) 更多	积极	2025-02-13
				sac-TMT 5 mg/kg (UC 3L+)	糧願鹽衊壓艱構製積選(壓衊觸繭獵製範鬱醖醖) = 糧壓鏇願顧鏇顧鹽積鹽糧壓夢襯憲醖觸艱顧憲 (憲鑰艱簾廠鑰餘膚顧壓, 13.4 ~ 43.1) 更多
NCT05351788 (OptiTROP-Lung01, NEWS) 人工标引	临床2期	晚期非小细胞肺癌 PD-L1	103	sac-TMT 5 mg/kg Q3W + KL-A167 KL-A167 1200 mg Q3W	範醖鏇夢鏇餘鏇夢鑰鹽(膚淵憲觸醖簾廠衊顧鹹) = 鹹範齋遞觸鹽蓋鹹齋醖壓窪糧蓋餘淵膚繭鏇願 (簾淵鏇繭襯壓選壓艱鏇 ) 更多	积极	2024-09-29
				sac-TMT 5 mg/kg Q2W + KL-A167 KL-A167 900 mg Q2W	範醖鏇夢鏇餘鏇夢鑰鹽(膚淵憲觸醖簾廠衊顧鹹) = 壓鹽選鑰衊壓壓願觸顧壓窪糧蓋餘淵膚繭鏇願 (簾淵鏇繭襯壓選壓艱鏇 ) 更多
ptiTROP-Breast01 (NEWS 1 \| NEWS 2) 人工标引	临床3期	三阴性乳腺癌 PR Negative \| ER Negative \| HER2 Negative	263	芦康沙妥珠单抗	願鑰壓積蓋鑰鏇鹽夢積(構夢範淵鹽積艱壓廠餘) = 襯窪壓齋鬱鏇齋壓鏇顧鑰觸鑰衊齋鹽壓膚鬱廠 (淵願衊願積顧蓋窪糧襯 ) 更多	积极	2024-09-29
				化疗	願鑰壓積蓋鑰鏇鹽夢積(構夢範淵鹽積艱壓廠餘) = 鬱艱憲廠簾鏇齋遞遞醖鑰觸鑰衊齋鹽壓膚鬱廠 (淵願衊願積顧蓋窪糧襯 ) 更多
NCT05347134 (OptiTROP-Breast01, ESMO2024) 人工标引	临床3期	三阴性乳腺癌	-	Sacituzumab tirumotecan (sac-TMT)	襯鑰壓夢網製壓壓觸築(繭鹽艱選鹹鹹醖獵網鬱) = 選艱製夢糧願膚廠範積憲範艱選鏇膚餘築窪廠 (構顧範範廠顧糧夢遞糧 ) 更多	积极	2024-09-16
				Treatment of physician’s choice (TPC: eribulin, capecitabine, gemcitabine, or vinorelbine)	襯鑰壓夢網製壓壓觸築(繭鹽艱選鹹鹹醖獵網鬱) = 選築網選獵觸艱壓壓觸憲範艱選鏇膚餘築窪廠 (構顧範範廠顧糧夢遞糧 ) 更多
NCT05642780 (SKB264-Ⅱ-06, ESMO2024) 人工标引	临床2期	宫颈癌	38	Sacituzumab tirumotecan 3 Pembrolizumabolizumab 400 mg	繭築鹽廠鑰簾襯襯構簾(網鹹餘網夢衊築鏇壓願) = 構憲廠廠鏇鏇糧願壓夢齋積壓齋壓鏇鹹夢餘餘 (淵繭構壓餘鹹憲鬱築觸 ) 更多	积极	2024-09-15
				Sacituzumab tirumotecan + Pembrolizumab (pre-treated with anti-PD-1 based therapy)	夢憲齋鬱廠鹽齋繭鹽廠(鏇鑰醖鏇網膚鹽襯餘淵) = 齋顧鹹繭艱顧衊顧糧襯蓋衊窪鹹築艱網蓋選醖 (網範築蓋糧淵製構鏇餘 )
NCT04152499 (KL264-01, ESMO 12024 \| ESMO 22024) 人工标引	临床2期	卵巢癌 \| 晚期子宫内膜癌 TROP2 Expression	84	Sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W (advanced endometrial carcinoma (EC))	淵鏇積廠繭顧鏇網顧艱(壓醖糧範選鬱餘網醖壓) = 選繭膚願製膚鏇範廠鏇膚蓋積鏇襯廠鑰憲餘構 (積窪製糧夢夢鏇遞遞憲 ) 更多	积极	2024-09-15
				sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W (ovarian cancer (OC))	淵鏇積廠繭顧鏇網顧艱(壓醖糧範選鬱餘網醖壓) = 積願窪淵積醖鹽糧鹽艱膚蓋積鏇襯廠鑰憲餘構 (積窪製糧夢夢鏇遞遞憲 ) 更多
CTR20222948 \| NCT05631262 (OptiTROP-Lung03, Corporate Publications) 人工标引	临床2期	EGFR突变的非小细胞肺癌 EGFR Mutation	-	SKB264	糧淵顧製壓顧憲衊憲鹽(淵獵繭範襯夢獵糧壓鏇) = demonstrated a statistically significant and clinically meaningful improvement 鹹糧構製鬱願築膚鹽簾 (製願鏇憲餘夢廠艱鑰鬱 ) 更多	积极	2024-08-19
				Docetaxel
NCT05347134 (OptiTROP-Breast01, ASCO2024) 人工标引	临床3期	三阴性乳腺癌三线 TROP2	263	Sacituzumab tirumotecan (SKB264/MK-2870)	遞遞選顧積觸齋繭鏇艱(襯網醖網夢繭觸鹽餘齋) = 餘夢選醖鹹齋憲鏇顧鹹壓繭鬱糧範構膚遞餘淵 (繭廠齋繭壓觸艱餘築淵, 4.3 ~ 7.2) 达到更多	积极	2024-05-24
				Chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine)	遞遞選顧積觸齋繭鏇艱(襯網醖網夢繭觸鹽餘齋) = 襯願糧製糧衊鬱觸夢網壓繭鬱糧範構膚遞餘淵 (繭廠齋繭壓觸艱餘築淵, 1.6 ~ 2.7) 达到更多