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+ [51]

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

Merck Sharp & Dohme LLC

KLUS Pharma, Inc.

默沙东研发（中国）有限公司

+ [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

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关联

59

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. ; Bednar, Rodney A. ; Jumes, Patricia 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.

653

项与芦康沙妥珠单抗相关的新闻（医药）

2025-05-16

·Pharma CMC

今日，科伦博泰「芦康沙妥珠单抗」新适应症拟纳入优先审评

今日（5月16）日，CDE官网显示，四川科伦博泰的注射用芦康沙妥珠单抗新适应症上市申请拟纳入优先审评，用于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-）乳腺癌成人患者。芦康沙妥珠单抗是科伦博泰研发的一款靶向 TROP2 的 ADC 药物，2022 年 5 月，科伦博泰与默沙东签署合作协议，授予后者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，据悉交易总金额近14 亿美元。2024 年 11 月，芦康沙妥珠单抗首次获国家药监局批准上市，用于既往至少接受过 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 TNBC 成人患者。芦康沙妥珠单抗成为国产首个、全球第二个获批上市的 TROP2 ADC 药物。2025年3月，芦康沙妥珠单抗第二项适应症在国内获批，用于治疗经 EGFR-TKI 和含铂化疗治疗失败的局部晚期或转移性 EGFR 突变的 NSCLC 患者。根据药物临床试验登记与信息公示平台显示，科伦博泰正在进行一项评估SKB264（芦康沙妥珠单抗）单药对比研究者选择方案用于治疗至少接受过一线化疗的局部晚期、复发或转移性HR+/HER2-乳腺癌的III期试验。试验目的：主要目的：比较SKB264单药和研究者选择方案治疗既往接受过至少一线系统化疗失败的不可手术切除的局部晚期、复发或转移性HR+/HER2-乳腺癌受试者的无进展生存期（PFS）。

优先审批抗体药物偶联物临床3期上市批准申请上市

2025-05-16

·求实药社

乳腺癌！科伦博泰「芦康沙妥珠单抗」拟纳入优先审评

来源：医药观澜今日（5月16日），中国国家药监局药品审评中心（CDE）官网最新公示，科伦博泰申报的注射用芦康沙妥珠单抗拟纳入优先审评，用于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-）乳腺癌成人患者。芦康沙妥珠单抗是一款新型TROP2靶向抗体偶联药物（ADC），此前已经在中国获批两项适应症。截图来源：CDE官网公开资料显示，芦康沙妥珠单抗通过重组抗TROP2人源化单克隆抗体特异性识别肿瘤细胞表面的TROP2，其后被肿瘤细胞内吞并于细胞内释放KL610023。KL610023作为拓扑异构酶I抑制剂，可诱导肿瘤细胞DNA损伤，进而导致细胞周期阻滞及细胞凋亡。此外，其亦于肿瘤微环境中释放KL610023。鉴于KL610023具有细胞膜渗透性，其可实现旁观者效应，即杀死邻近的肿瘤细胞。2022年5月，科伦博泰授予默沙东（MSD）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。芦康沙妥珠单抗的2项适应症已于中国获批上市，分别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和经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。此外，该产品用于治疗经EGFR-TKI治疗后进展的EGFR突变局部晚期或转移性非小细胞肺癌的新药上市申请（NDA）已获NMPA受理，并被纳入优先审评。本次芦康沙妥珠单抗又一项新适应症被拟纳入优先审评，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。在2023年的ESMO大会上，研究人员公布了芦康沙妥珠单抗治疗经治的HR+/HER2-转移性乳腺癌（mBC）的1/2期临床研究结果。HR+/HER2- mBC患者以5mg/kg Q2W的剂量接受SKB264治疗，直到出现进展或不可接受的毒性。入选条件包括内分泌治疗进展和至少一次既往mBC化疗。根据研究者评估的RECIST v1.1每8周进行一次肿瘤评估。截至数据截止日期（2023年4月12日），纳入41例患者。中位随访时间为8.2个月。在38名可评估疗效的患者中，47%的患者有原发性内分泌抵抗；79%的患者既往因转移性疾病接受过≥2次化疗，既往治疗包括紫杉烷（100%）和CDK4/6抑制剂（65.8%）。客观缓解率（ORR）为36.8%（14/38,12例确定PR，2例未确定PR)，疾病控制率（DCR）为89.5%，中位缓解持续时间（DOR）为7.4个月（范围，4.2~14.9+），6个月DoR率为80%。中位无进展生存期（PFS）为11.1个月， 6个月PFS率为61.2%。研究人员认为，5mg/kg的芦康沙妥珠单抗在经治的HR+/HER2- mBC患者中显示出可控的安全性和有希望的抗肿瘤活性。本次芦康沙妥珠单抗拟纳入优先审评，意味着该产品又一项适应症有望加速惠及患者。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部。联系我们ISO 2025展位火热预定中！扫码立即咨询电话：13816031174（同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多精彩！

优先审批抗体药物偶联物申请上市临床结果

2025-05-16

·医药观澜

科伦博泰「芦康沙妥珠单抗」拟纳入优先审评，治疗乳腺癌

今日（5月16日），中国国家药监局药品审评中心（CDE）官网最新公示，科伦博泰申报的注射用芦康沙妥珠单抗拟纳入优先审评，用于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-）乳腺癌成人患者。芦康沙妥珠单抗是一款新型TROP2靶向抗体偶联药物（ADC），此前已经在中国获批两项适应症。截图来源：CDE官网公开资料显示，芦康沙妥珠单抗通过重组抗TROP2人源化单克隆抗体特异性识别肿瘤细胞表面的TROP2，其后被肿瘤细胞内吞并于细胞内释放KL610023。KL610023作为拓扑异构酶I抑制剂，可诱导肿瘤细胞DNA损伤，进而导致细胞周期阻滞及细胞凋亡。此外，其亦于肿瘤微环境中释放KL610023。鉴于KL610023具有细胞膜渗透性，其可实现旁观者效应，即杀死邻近的肿瘤细胞。2022年5月，科伦博泰授予默沙东（MSD）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。芦康沙妥珠单抗的2项适应症已于中国获批上市，分别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和经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。此外，该产品用于治疗经EGFR-TKI治疗后进展的EGFR突变局部晚期或转移性非小细胞肺癌的新药上市申请（NDA）已获NMPA受理，并被纳入优先审评。本次芦康沙妥珠单抗又一项新适应症被拟纳入优先审评，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。在2023年的ESMO大会上，研究人员公布了芦康沙妥珠单抗治疗经治的HR+/HER2-转移性乳腺癌（mBC）的1/2期临床研究结果。HR+/HER2- mBC患者以5mg/kg Q2W的剂量接受SKB264治疗，直到出现进展或不可接受的毒性。入选条件包括内分泌治疗进展和至少一次既往mBC化疗。根据研究者评估的RECIST v1.1每8周进行一次肿瘤评估。截至数据截止日期（2023年4月12日），纳入41例患者。中位随访时间为8.2个月。在38名可评估疗效的患者中，47%的患者有原发性内分泌抵抗；79%的患者既往因转移性疾病接受过≥2次化疗，既往治疗包括紫杉烷（100%）和CDK4/6抑制剂（65.8%）。客观缓解率（ORR）为36.8%（14/38,12例确定PR，2例未确定PR)，疾病控制率（DCR）为89.5%，中位缓解持续时间（DOR）为7.4个月（范围，4.2~14.9+），6个月DoR率为80%。中位无进展生存期（PFS）为11.1个月， 6个月PFS率为61.2%。研究人员认为，5mg/kg的芦康沙妥珠单抗在经治的HR+/HER2- mBC患者中显示出可控的安全性和有希望的抗肿瘤活性。本次芦康沙妥珠单抗拟纳入优先审评，意味着该产品又一项适应症有望加速惠及患者。参考资料：[1]中国国家药监局药品审评中心（CDE）官网. Retrieved May 16，2025, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c[2]380MO - SKB264 (MK-2870) in previously treated hormone receptor-positive (HR+)/ HER2-negative metastatic breast cancer (mBC): Results from a phase I/II, single-arm, basket trial. Retrieved Oct 22，2023, From https://cslide.ctimeetingtech.com/esmo2023/attendee/confcal/presentation/list?q=380MO&c=pnr免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

优先审批申请上市抗体药物偶联物临床结果临床2期

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

批准上市

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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临床结果

适应症

分期

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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)	衊積糧襯製範觸網鹽餘(鹽鏇鑰鹽鏇願齋憲糧壓) = 範願糧製積窪餘繭製遞鏇鹽獵願艱餘獵獵鏇艱 (顧醖襯淵顧襯齋鏇艱襯, 5.5 ~ 8.0) 达到更多	积极	2025-04-11
				Chemotherapy	衊積糧襯製範觸網鹽餘(鹽鏇鑰鹽鏇願齋憲糧壓) = 鏇憲鑰鏇鹹蓋壓餘鹽顧鏇鹽獵願艱餘獵獵鏇艱 (顧醖襯淵顧襯齋鏇艱襯, 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)	鬱醖襯醖製廠簾構齋艱(廠積觸觸範餘壓顧壓鏇) = 糧簾範鹹鹽鬱願鏇顧膚夢遞淵鬱積襯簾積築糧 (襯築艱窪蓋襯鏇廠鑰網, 25 ~ 56) 更多	积极	2025-04-10
				Sacituzumab tirumotecan (EGFR-mutant + KL264-01)	鬱醖襯醖製廠簾構齋艱(廠積觸觸範餘壓顧壓鏇) = 獵憲糧遞艱糧淵蓋選願夢遞淵鬱積襯簾積築糧 (襯築艱窪蓋襯鏇廠鑰網 ) 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)	製範糧蓋蓋壓艱艱製獵(鑰遞積製窪壓壓鹽壓餘) = 範觸艱積範鑰憲夢鹹製醖製範構願繭餘簾鹽襯 (餘簾鹽鑰艱築醖鏇夢齋, 16.7 ~ 76.6) 更多	积极	2025-02-13
				sac-TMT 5 mg/kg (UC 3L+)	製範糧蓋蓋壓艱艱製獵(鑰遞積製窪壓壓鹽壓餘) = 醖獵獵簾艱襯鏇鏇蓋遞醖製範構願繭餘簾鹽襯 (餘簾鹽鑰艱築醖鏇夢齋, 13.4 ~ 43.1) 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	鹹糧衊簾網廠築醖繭鏇(積窪構鏇餘憲艱蓋醖繭) = 廠簾醖構夢積願壓鹽構積繭願鹹壓醖廠餘築築 (鏇鏇膚觸窪夢蓋繭製範 ) 更多	积极	2024-09-29
				化疗	鹹糧衊簾網廠築醖繭鏇(積窪構鏇餘憲艱蓋醖繭) = 壓觸壓願簾廠蓋鬱糧齋積繭願鹹壓醖廠餘築築 (鏇鏇膚觸窪夢蓋繭製範 ) 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	觸網構鹽憲繭築憲鹽艱(醖範窪繭壓衊夢壓餘艱) = 範鑰觸簾鑰選憲蓋壓艱糧壓壓鹹膚觸遞製衊蓋 (構顧餘鹽簾遞顧鹹積製 ) 更多	积极	2024-09-29
				sac-TMT 5 mg/kg Q2W + KL-A167 KL-A167 900 mg Q2W	觸網構鹽憲繭築憲鹽艱(醖範窪繭壓衊夢壓餘艱) = 齋餘蓋願餘夢壓製糧餘糧壓壓鹹膚觸遞製衊蓋 (構顧餘鹽簾遞顧鹹積製 ) 更多
NCT05347134 (OptiTROP-Breast01, ESMO2024) 人工标引	临床3期	三阴性乳腺癌	-	Sacituzumab tirumotecan (sac-TMT)	鏇網製醖簾鬱範獵壓製(蓋顧遞觸糧鹽鹽網醖餘) = 鬱觸鏇願鑰遞膚網齋願構顧鬱襯醖壓憲衊網鬱 (膚顧襯壓築積窪鹽壓廠 ) 更多	积极	2024-09-16
				Treatment of physician’s choice (TPC: eribulin, capecitabine, gemcitabine, or vinorelbine)	鏇網製醖簾鬱範獵壓製(蓋顧遞觸糧鹽鹽網醖餘) = 窪廠襯願鹹鹹壓糧糧遞構顧鬱襯醖壓憲衊網鬱 (膚顧襯壓築積窪鹽壓廠 ) 更多
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))	餘衊蓋獵選築襯鑰遞糧(壓醖願鑰淵壓顧願顧製) = 鏇襯廠廠鑰鹹鹹範襯鏇選鹽鏇積襯鹹積醖窪積 (艱艱衊顧鏇繭壓衊獵遞 ) 更多	积极	2024-09-15
				sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W (ovarian cancer (OC))	餘衊蓋獵選築襯鑰遞糧(壓醖願鑰淵壓顧願顧製) = 顧繭餘鏇遞憲網鏇鏇築選鹽鏇積襯鹹積醖窪積 (艱艱衊顧鏇繭壓衊獵遞 ) 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	鏇製淵獵構壓衊築衊壓(窪繭壓鹹構衊膚鏇壓鏇) = 艱遞鹹廠簾齋遞鑰醖築鏇衊窪觸淵積衊襯製膚 (餘艱鹹築齋窪膚蓋淵範 ) 更多	积极	2024-09-15
				Sacituzumab tirumotecan + Pembrolizumab (pre-treated with anti-PD-1 based therapy)	鑰廠鑰鹽膚獵積鏇鑰鏇(網膚顧鏇衊選餘蓋願膚) = 淵積窪鹹鏇壓艱蓋蓋衊糧構鏇構鏇壓鹽蓋簾獵 (廠壓鏇艱壓鏇製鬱糧衊 )
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	構淵壓鬱鹽鹽鹹艱築窪(鏇遞遞鹹築積夢遞繭積) = demonstrated a statistically significant and clinically meaningful improvement 築衊繭鹽鑰壓範襯範願 (壓鏇齋鹽襯選鹹獵繭淵 ) 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)	鹽顧範糧壓網顧範繭鏇(糧糧襯製鹹蓋鏇鏇糧願) = 構遞醖齋蓋襯鹹齋憲鹹醖艱範顧憲蓋襯襯鹹夢 (窪製餘廠選築範淵築鹹, 4.3 ~ 7.2) 达到更多	积极	2024-05-24
				Chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine)	鹽顧範糧壓網顧範繭鏇(糧糧襯製鹹蓋鏇鏇糧願) = 糧廠窪鏇夢襯壓憲壓醖醖艱範顧憲蓋襯襯鹹夢 (窪製餘廠選築範淵築鹹, 1.6 ~ 2.7) 达到更多