KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC)

Researchers are looking for other ways to treat metastatic squamous non-small cell lung cancer (NSCLC). Squamous NSCLC is cancer that starts in squamous cells, which are flat cells that line the inside of the airways in the lungs. Metastatic means the cancer has spread to other parts of the body.
Standard treatment (usual treatment) for metastatic squamous NSCLC is immunotherapy with or without chemotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. However, standard treatment may not work or may stop working to treat metastatic squamous NSCLC.
Researchers want to learn if study treatments that are antibody drug conjugates (ADCs) can treat metastatic squamous NSCLC that did not respond (get smaller or go away) to standard treatment. An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.
The main goals of this study are to learn about:
* The cancer response to the study treatments compared to chemotherapy
* The safety of the study treatments and if people tolerate them
This study is one of the substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

开始日期2025-05-28

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT06780085

/ Recruiting临床2期

KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC)

Researchers are looking for new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the inside of the lungs.
Standard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing.
However, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells.
Researchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn:
* About the safety of the study treatments and if people tolerate them
* How many people have the cancer respond to the study treatments

开始日期2025-05-13

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT06843447

/ Recruiting临床1/2期

A Phase 1b/2 Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan With or Without Other Anticancer Investigational Agents in Participants With High-grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Have Relapsed After Prior Platinum-based Chemotherapy

Researchers are looking for other ways to treat relapsed high-grade serous ovarian cancer. Relapsed means the cancer came back after treatment. High-grade means the cancer cells grow and spread quickly. Serous means the cancer started in the cells that cover the ovaries, the lining of the belly, or in the fallopian tubes.
Standard treatment (usual treatment) for people with relapsed high-grade serous ovarian cancer may include:
* Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing
* Targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread
Raludotatug deruxtecan (R-DXd) is a study treatment that is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to know if R-DXd is safe to take with other treatments and if people tolerate them together. They also want to learn how many people have the cancer respond (gets smaller or goes away) to the treatments.

开始日期2025-04-15

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

100 项与 Raludotatug deruxtecan 相关的临床结果

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100 项与 Raludotatug deruxtecan 相关的转化医学

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100 项与 Raludotatug deruxtecan 相关的专利（医药）

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项与 Raludotatug deruxtecan 相关的文献（医药）

2024-11-14·JOURNAL OF MEDICINAL CHEMISTRY

Evaluation of Double Self-Immolative Linker-Based Antibody–Drug Conjugate FDA022-BB05 with Enhanced Therapeutic Potential

Article

作者: Liu, Shuangxi ; Yin, Sicheng ; Zhang, Yifan ; Zhang, Wenbo ; Yang, Tong ; Shen, Keyu ; Zhu, Shulei ; Xie, Qian ; Gao, Bei ; Wu, Yinghan ; Song, Ruiwen ; Cao, Xuemei ; Qiu, Xuefei ; Cheng, Zhiyang ; Wang, Baoxia ; Zhao, Teng ; Xu, Jun ; Wu, Jingsong ; Li, Weinan ; Guo, Qingsong ; Wang, Lei ; Lu, Wei

Typical antibody-drug conjugates (ADCs) with valine-alanine linkage, often conjugated with the amino group in payloads, face challenges when interacting with hydroxyl group-containing payloads. Herein, we introduced a transformative Val-Ala-based double self-immolative linker-payload platform, reshaping ADCs by optimizing hydroxyl group-containing payload integration. Utilizing this platform, FDA022-BB05 was successfully conjugated with the hydroxyl group-containing payload DXd using trastuzumab (FDA022) as the monoclonal antibody (mAb). FDA022-BB05 demonstrated enhanced stability, effective cathepsin B sensitivity, reduced cell proliferation, increased bystander killing, and targeted delivery. Notably, acute toxicity evaluations in diverse preclinical models indicated favorable safety profiles and tolerability, with a broad therapeutic index in HER2-positive and -negative xenografts. Overall, these compelling findings support the promising therapeutic potential of FDA022-BB05, emphasizing the significance of diverse linker-payload platform strategies. This ADC is a valuable addition to targeted cancer therapy development, currently advancing through phase I clinical trials.

2024-10-01·MOLECULAR CANCER THERAPEUTICS

FZ-AD005, a Novel DLL3-Targeted Antibody–Drug Conjugate with Topoisomerase I Inhibitor, Shows Potent Antitumor Activity in Preclinical Models

Article

作者: Wu, Jinsong ; Lu, Wei ; Shen, Jiafei ; Zhao, Teng ; Gao, Bei ; Yang, Tong ; Song, Ruiwen ; Xie, Qian ; Guo, Qingsong ; Lou, Sensen ; Zhang, Yifan ; Zhu, Shulei ; Li, Weinan ; Wang, Lei

Abstract:

Delta-like ligand 3 (DLL3) is overexpressed in small cell lung cancer (SCLC) and has been considered an attractive target for SCLC therapy. Rovalpituzumab tesirine was the first DLL3-targeted antibody–drug conjugate (ADC) to enter clinical studies. However, serious adverse events limited progress in the treatment of SCLC with rovalpituzumab tesirine. In this study, we developed a novel DLL3-targeted ADC, FZ-AD005, by using DXd with potent cytotoxicity and a relatively better safety profile to maximize the therapeutic index. FZ-AD005 was generated by a novel anti-DLL3 antibody, FZ-A038, and a valine–alanine (Val–Ala) dipeptide linker to conjugate DXd. Moreover, Fc-silencing technology was introduced in FZ-AD005 to avoid off-target toxicity mediated by FcγRs and showed negligible Fc-mediated effector functions in vitro. In preclinical evaluation, FZ-AD005 exhibited DLL3-specific binding and demonstrated efficient internalization, bystander killing, and excellent in vivo antitumor activities in cell line–derived xenograft and patient-derived xenograft models. FZ-AD005 was stable in circulation with acceptable pharmacokinetic profiles in cynomolgus monkeys. FZ-AD005 was well tolerated in rats and monkeys. The safety profile of FZ-AD005 was favorable, and the highest nonseverely toxic dose was 30 mg/kg in cynomolgus monkeys. In conclusion, FZ-AD005 has the potential to be a superior DLL3-targeted ADC with a wide therapeutic window and is expected to provide clinical benefits for the treatment of patients with SCLC.

2024-10-01·BIOORGANIC CHEMISTRY

Novel antibody-drug conjugates based on DXd-ADC technology

Review

作者: Chen, Yuchen ; Ye, Qiang ; Hu, Xuefang ; Bai, Lan ; Shi, Jianyou ; Ren, Zhiwen ; Chen, Rong ; Hu, Yuan

In recent years, antibody-drug conjugate (ADC) technology, which uses monoclonal antibodies (mAbs) to specifically deliver effective cytotoxic payloads to tumor cells, has become a promising method of tumor targeted therapy. ADCs are a powerful class of biopharmaceuticals that link antibodies targeting specific antigens and small molecule drugs with potent cytotoxicity via a linker, thus enabling selective destruction of cancer cells while minimizing systemic toxicity. DXd is a topoisomerase I inhibitor that induces DNA damage leading to cell cycle arrest, making it an option for ADC payloads. The DXd-ADC technology, developed by Daiichi Sankyo, is a cutting-edge platform that produces a new generation of ADCs with improved therapeutic metrics and has shown significant therapeutic potential in various types of cancer. This review provides a comprehensive assessment of drugs developed with DXd-ADC technology, with a focus on mechanisms of action, pharmacokinetics studies, preclinical data, and clinical outcomes for DS-8201a, U3-1402, DS-1062a, DS-7300a, DS-6157a, and DS-6000a. By integrating existing data, we aim to provide valuable insights into the current therapeutic status and future prospects of these novel agents.

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项与 Raludotatug deruxtecan 相关的新闻（医药）

2026-06-16

·缔码生物

2026 ASCO靶点盘点（一）：ADC篇

点击蓝字关注我们 ADC仍然是2026 ASCO中最值得关注的药物类型之一。与传统单抗相比，ADC的核心优势在于“抗体靶向识别+细胞毒载荷递送”，因此靶点选择直接决定药物的适应症空间、疗效上限和安全性边界。从本届ASCO摘要来看，ADC研发已经从HER2、TROP2等成熟靶点，进一步扩展到HER3、Nectin-4、c-MET、CLDN18.2、B7-H3、FOLR1、CDH6、B7-H4等更多实体瘤靶点。更值得注意的是，很多ADC研究已经不再局限于后线单药治疗，而是进入新辅助、一线联合、围手术期、免疫联合以及biomarker精准筛选阶段。 01 HER2/ERBB2 HER2仍然是2026 ASCO中最活跃的ADC靶点之一。与过去主要集中在HER2阳性乳腺癌不同，本届ASCO中HER2 ADC的适应症边界进一步扩大，覆盖HER2-low乳腺癌、HER2表达胃癌、胃食管结合部癌、卵巢癌等多个实体瘤。从药物看，荣昌生物的disitamab vedotin/RC48是HER2 ADC中非常值得关注的药物。其在HER2表达晚期卵巢癌新辅助治疗中，联合卡铂取得了较高的手术转化效果，摘要显示完全切除率达到91.6%，ORR达到87.5%，且未出现外周神经毒性。这说明HER2 ADC不仅可以作为晚期后线治疗选择，也有潜力前移到新辅助和围手术期场景。在胃癌/胃食管结合部癌中，RC48也从后线单药向一线联合治疗推进。相关研究设计中，RC48联合trastuzumab和PD-1抑制剂在既往II期研究中显示出优于对照组的ORR信号，后续III期研究则进一步验证“HER2 ADC+抗HER2单抗+免疫治疗”能否成为HER2-high胃癌一线治疗的新组合。 02 TROP2/TACSTD2 TROP2是ADC领域继HER2之后最重要的泛实体瘤靶点之一。2026 ASCO中，TROP2 ADC的核心战场仍然是乳腺癌，尤其是三阴性乳腺癌；同时，TROP2也在NSCLC、尿路上皮癌和其他实体瘤中持续扩展。 Gilead的sacituzumab govitecan是TROP2 ADC的代表药物。本届ASCO中，ASCENT-04、ASCENT-03等研究继续围绕三阴性乳腺癌展开，重点不再只是证明TROP2 ADC后线有效，而是进一步探索其在一线治疗、免疫联合和特定biomarker人群中的位置。尤其是sacituzumab govitecan联合pembrolizumab，用于PD-L1阳性转移性TNBC，体现了“TROP2 ADC+PD-1”组合成为乳腺癌一线治疗的重要方向。此外，sacituzumab tirumotecan/sac-TMT在NSCLC中与pembrolizumab联合的研究，也提示TROP2 ADC正在从乳腺癌向肺癌拓展。 03 HER3/ERBB3 HER3的特点是“靶点本身不一定是强驱动基因，但与耐药密切相关”。在EGFR、HER2通路治疗后，HER3常常参与旁路激活和耐药形成，因此HER3 ADC可作为“耐药后治疗”和“通路补偿”的药物。 Daiichi Sankyo的patritumab deruxtecan/HER3-DXd是HER3 ADC的代表药物。2026 ASCO中，HER3-DXd出现在HR+/HER2-乳腺癌等研究设计中，说明HER3 ADC正在从肺癌耐药场景向乳腺癌扩展。与此同时，BNT326/YL202等HER3 ADC还被设计为与PD-L1×VEGF双抗联合，提示HER3 ADC未来并不一定只是单药后线治疗，而可能与双抗、免疫和抗血管生成疗法形成组合。值得注意的是，JSKN016这类TROP2/HER3双靶点ADC也出现在HER2阴性乳腺癌研究中。这类设计的意义在于通过一个ADC分子同时覆盖两个肿瘤相关抗原，理论上有助于提高肿瘤覆盖率，并降低单一靶点表达异质性带来的疗效不稳定。 04 Nectin-4 Nectin-4是尿路上皮癌ADC的核心靶点。随着enfortumab vedotin的临床应用，Nectin-4已经从概念性靶点变成成熟治疗靶点。2026 ASCO中，围绕Nectin-4的研究进一步扩大，不仅包括尿路上皮癌，还延伸至肌层浸润性膀胱癌、胰腺癌和其他实体瘤。 Bicycle Therapeutics的zelenectide pevedotin/BT8009是新一代Nectin-4靶向药物方向之一。本届ASCO中，BT8009既有一线局晚期或转移性尿路上皮癌联合pembrolizumab的研究，也有经治转移性尿路上皮癌单药研究。这说明Nectin-4赛道正在从传统ADC扩展到更多递送形式和联合免疫方案。恒瑞医药的SHR-A2102则代表中国药企在Nectin-4 ADC方向的布局。其在肌层浸润性膀胱癌围手术期治疗以及KRAS G12D胰腺导管腺癌联合方案中出现，提示Nectin-4靶点正在尝试突破尿路上皮癌单一适应症边界。 05 c-MET/MET c-MET是与肿瘤侵袭、转移和EGFR-TKI耐药高度相关的靶点。与MET小分子抑制剂相比，c-MET ADC更关注MET蛋白高表达、MET扩增或MET相关耐药人群。 AbbVie的telisotuzumab adizutecan/ABBV-400是本届ASCO中c-MET ADC的代表药物。其研究覆盖MET扩增晚期实体瘤、铂耐药卵巢癌、头颈鳞癌以及EGFR突变NSCLC等多个方向，说明c-MET ADC并不是单一癌种项目，而是围绕MET表达和扩增进行跨癌种开发。此外，正大天晴的TQB6411是EGFR/c-MET双靶点ADC，进一步说明MET靶点正在与EGFR耐药机制结合。对于EGFR突变NSCLC患者，MET扩增或MET通路激活是常见耐药机制之一，因此EGFR×c-MET ADC的逻辑是同时覆盖原始驱动通路和耐药旁路。 06 CLDN18.2 CLDN18.2是消化道肿瘤中最热门的膜蛋白靶点之一，尤其集中在胃癌、胃食管结合部癌和胰腺癌。与HER2相比，CLDN18.2的差异点在于它更偏向胃肠道来源肿瘤，且药物形式非常丰富，包括单抗、ADC、CAR-T、双抗和影像诊断。 2026 ASCO中，BL-M05D1和XNW27011是CLDN18.2 ADC的代表项目。XNW27011既用于CLDN18.2阳性胃癌/胃食管结合部腺癌，也探索晚期胰腺导管腺癌，说明CLDN18.2靶点正在从胃癌向胰腺癌拓展。Astellas的zolbetuximab则代表CLDN18.2单抗方向，其相关摘要更偏向biomarker分析和疗效预测。科济药业的satricabtagene autoleucel/satri-cel则体现了CLDN18.2细胞治疗路线。也就是说，CLDN18.2已经不是某一种药物形式的靶点，而是一个围绕消化道肿瘤建立多技术路线竞争的靶点平台。 07 B7-H3/CD276 B7-H3是近年来快速升温的新兴肿瘤靶点，在肺癌、前列腺癌、妇科肿瘤、肉瘤、脑胶质瘤和儿童肿瘤中均有探索。它的特点是表达范围广，既可用于ADC，也可用于核药、CAR-T和双抗设计。 2026 ASCO中，SYS6043是B7-H3 ADC的代表项目，定位于晚期实体瘤。与HER2、TROP2这类成熟ADC靶点相比，B7-H3仍处于更早期的临床验证阶段，但其“泛实体瘤表达+多药物形式可开发”的特征，使其具备很强的平台价值。同时，B7-H3还出现在前列腺癌放射性偶联药物、胶质母细胞瘤CAR-T以及尿路上皮癌耐药后蛋白表达谱分析中。这说明B7-H3不只是ADC靶点，也可能成为“耐药后新靶点”和“肿瘤微环境相关靶点”。 08 FOLR1/FRα FOLR1，也称FRα，是卵巢癌ADC中非常重要的靶点。与HER2、TROP2这类泛癌种靶点不同，FOLR1的优势在于适应症相对清晰，尤其适用于FRα高表达的复发性卵巢癌。 ImmunoGen/AbbVie的mirvetuximab soravtansine是FOLR1 ADC的代表药物。2026 ASCO中，mirvetuximab soravtansine继续围绕FRα高表达复发性卵巢癌展开，同时也有眼部毒性和安全性分析。百奥泰的BAT8006联合BAT1308用于晚期子宫内膜癌，则提示FOLR1靶点可能从卵巢癌向其他妇科肿瘤扩展。不过，FOLR1未来能否进一步扩大适应症，还需要看不同肿瘤中的表达水平和ADC安全性窗口。 09 CDH6 CDH6是妇科肿瘤和肾癌中值得关注的新兴ADC靶点。与FOLR1相比，CDH6的临床开发更早，但2026 ASCO中已经出现了raludotatug deruxtecan/R-DXd的药代、暴露-反应分析和铂耐药卵巢癌后续研究设计，说明该靶点正在从早期探索走向更系统的临床开发。 Daiichi Sankyo的R-DXd是CDH6 ADC的代表药物。其研究聚焦卵巢癌，尤其是铂耐药卵巢癌。该人群治疗选择有限，如果CDH6 ADC能够在疗效和安全性上形成优势，将为妇科肿瘤ADC增加一个新的靶点选择。同时，SIM0505等CDH6 ADC的出现，也提示该靶点赛道正在吸引更多公司进入。CDH6成为“继FOLR1之后，卵巢癌ADC的又一个潜力靶点”。 10 B7-H4/VTCN1 B7-H4是妇科肿瘤和乳腺癌ADC中的新兴免疫相关靶点。2026 ASCO中，B7-H4 ADC包括BG-C9074和AstraZeneca的puxitatug samrotecan/AZD8205等项目，主要面向晚期实体瘤和B7-H4选择性子宫内膜癌。 AZD8205的研究设计将B7-H4表达筛选与晚期/转移性子宫内膜癌治疗结合，说明该靶点的开发逻辑与FOLR1类似：先找到表达明确的人群，再验证ADC能否优于传统化疗。BG-C9074的早期临床研究则提示B7-H4仍在探索剂量、安全性和初步疗效窗口。 B7-H4，它可能成为妇科肿瘤ADC继FRα、HER2、CDH6之后的又一个新靶点。靶点之外：加速创新药研发的先导分子资源从HER2、TROP2到CLDN18.2、B7-H3、FOLR1，2026 ASCO再次证明：ADC已进入“多靶点竞争”时代。然而，ADC的成功并不只取决于靶点本身。一个优质ADC分子的核心前提，是获得具有高亲和力、高内吞活性、良好可开发性的抗体分子。尤其在新兴靶点竞争加速的背景下，谁能更快获得优质先导抗体，往往决定项目推进效率。围绕热门ADC靶点，缔码已建立覆盖HER2、TROP2、HER3、CLDN18.2、B7-H3、FOLR1、Nectin-4、MET等多个实体瘤靶点的先导抗体分子库，支持抗体筛选、ADC分子构建、内吞评价及早期成药性研究，助力研究者加速ADC开发。以下为部分热门ADC靶点先导抗体分子研究进展：往期推荐 HER2 | 实体瘤治疗的重要靶点 ➠ TROP2-ADC药物研究进展 ➠ 实体瘤靶点HER3/ERBB3-闪光赛道不仅仅是ADC ➠ Nectin-4-ADC赛道新兴靶点 ➠ 因ADC出圈的免疫检查点B7-H3，其它靶向疗法现况如何？ ➠ FRα/FOLR1-又一因ADC爆火的抗癌靶点 ➠ CDH6 ADC，听说治疗卵巢癌效果还不错！ ➠ 关于缔码缔码生物科技有限公司（DIMA Biotech）是一家专注于为生物制药公司提供创新产品与服务的生物技术企业。不同于传统CRO，缔码提供经过功能验证的现货先导抗体分子，帮助客户加速抗体药物早期研发。目前，缔码已建立覆盖500+可成药靶点的5000+现货先导抗体资源库，提供明确的抗体序列及验证数据。同时，缔码可提供300+现货全长多跨膜蛋白，覆盖GPCR、离子通道等高难度膜蛋白靶点，为抗体发现、功能验证及药物开发提供关键研究工具。缔码拥有多个自主研发技术平台，包括： • DiMPro™膜蛋白表达平台：提供Nanodisc、MNP和Detergent三大全长多跨膜蛋白制备体系，覆盖GPCR、离子通道等高难度靶点。 • DIMA mAb™单B细胞抗体开发平台：可在 20天内获得同一靶点超10,000个阳性兔单抗分子。 • DiLibrary™抗体工程平台：支持抗体人源化、亲和力成熟及可成药性优化。 • DiAssay™体外功能验证平台：提供 ADC、双抗及CAR-T等相关体外验证服务。长按扫码关注微信号| 缔码生物电话| 400-006-0995/18062749453 网址| www.dimabio.cn 邮箱| info@dimabio.com

2026-06-11

·亿药前谈

ADC赛道再变天：当"魔法子弹"遇上肺癌，谁才能真正突围？

点击蓝字,立即关注 FOLLOW US 近日，一项备受关注的肺癌联合用药III期临床研究被按下暂停键。与此同时，中国创新药企的一款同类产品却刚刚交出亮眼成绩单。在ADC药物狂飙突进的年代，这两件事放在一起，值得我们好好聊聊。 01 一项重磅联合疗法研究的提前终止 6月初，国际医药巨头默沙东与吉利德联合宣布，提前终止Trodelvy（一款靶向Trop2的ADC药物）与默沙东明星PD-1抑制剂Keytruda（K药）联合用于一线治疗晚期非小细胞肺癌（NSCLC）的III期临床研究——KEYNOTE-D46/EVOKE-03。这项研究针对的是PD-L1高表达（TPS≥50%）的初治转移性非小细胞肺癌患者，原计划要到2027年才能完成主要数据收集。是什么让两大药企决定提前"止损"？独立数据监测委员会在审查了当前的无进展生存期（PFS）最终分析和总生存期（OS）中期数据后给出了建议：联合用药组虽然在延缓疾病进展方面观察到了一定趋势，但未达到统计学意义上的显著差异；而想要在接下来的随访中观察到总生存期的显著获益，可能性也不大。好消息是，联合用药没有发现新的安全性问题——这明确指向了一个结论：不是安全性问题，而是疗效确实不够看。 02 科普小课堂：ADC是个啥？在聊清楚这件事为什么重要之前，不妨先简单科普一下什么是ADC。 ADC全称抗体偶联药物（Antibody-Drug Conjugate），江湖人称"魔法子弹"。它的设计思路非常精妙：通过一个"导航系统"（单克隆抗体）精准识别肿瘤细胞表面的特定蛋白，再 tether 上一颗"炸弹"（细胞毒性药物，也叫载荷/payload），中间用一根"保险绳"（连接子/linker）拴住。理论上，ADC进入体内后，抗体部分负责带路，找到癌细胞并与之结合，然后整体被癌细胞"吃掉"。进入癌细胞内部后，连接子断裂，释放出毒性载荷，从内部炸死癌细胞。这种"精准制导"的设计，本意是让药物主要杀伤癌细胞，减少对正常组织的伤害。但现实世界往往比设计图纸复杂得多——连接子太不稳定，药物可能在到达肿瘤之前就提前"松绑"，导致炸弹在血液循环中提前释放，不仅增加了全身毒性，还削弱了到达肿瘤的药物剂量。 03 Trodelvy的困境：两次折戟，问题出在哪？其实，这不是Trodelvy在肺癌领域的第一次失利。早在这次一线治疗研究之前，Trodelvy在二线非小细胞肺癌的EVOKE-01研究中就已经碰壁——对比传统化疗药物多西他赛，未能显示出显著优势。如果我们仔细复盘EVOKE-01的数据，就能发现一些端倪，也能理解为什么这次的联合用药研究同样走不通：首先，疗效衰减明显。研究预设Trodelvy能将患者的死亡风险降低约25%（HR=0.75），但实际观察到的数值为0.84，随着随访时间延长甚至进一步恶化到0.89。这说明Trodelvy可能能带来短暂的肿瘤控制效果，但难以转化为真正的生存获益。其次，免疫治疗应答者反而"拖后腿"。在亚组分析中，那些此前对免疫治疗有应答的患者，使用Trodelvy后的表现反而更差（HR=1.09）；而对免疫治疗无应答的患者，数据相对好一些（HR=0.75）。这个反直觉的现象说明，Trodelvy的加入某种程度上"稀释"了免疫治疗的优势效果。第三，肿瘤缓解数据并不漂亮。 Trodelvy组的客观缓解率（ORR）只有13.7%，甚至低于化疗组的18.1%；中位无进展生存期（mPFS）方面，4.1个月对比3.9个月，几乎可以说是没有差异。第四，安全性问题突出。约50%的患者出现严重中性粒细胞减少（≥3级），约10%出现严重腹泻。如此高的血液学毒性和胃肠道毒性，提示药物的连接子可能不够稳定，导致载荷提前释放，一方面让患者承受了更多副作用，另一方面到达肿瘤组织的有效药物浓度反而不足。此外，Trodelvy使用的载荷是SN-38，这种拓扑异构酶I抑制剂虽然在三阴性乳腺癌和尿路上皮癌中表现尚可，但对非小细胞肺癌的杀伤力似乎并不理想。把这些因素综合起来，再看这次的一线联合用药研究：研究对象是PD-L1高表达（TPS≥50%）的人群，而这恰恰是K药单药疗效最强的领域。在EVOKE-01中，免疫应答亚组就已经出现了"反向稀释"效应，到了K药"主场"的一线高表达人群中，Trodelvy能带来的额外获益空间自然就更小了。再加上其本身偏窄的治疗窗口和安全性负担，这次提前终止，其实在意料之中。 04 中国创新药的高光时刻：Sac-TMT做对了什么？就在Trodelvy遭遇滑铁卢的同时，科伦博泰旗下靶向同样靶点（Trop2）的ADC药物Sac-TMT（也称SKB264/MK-2870）却传来了好消息。其在中国开展的OptiTROP-Lung05研究中，Sac-TMT联合K药用于一线PD-L1阳性（TPS≥1%）的非小细胞肺癌患者，结果显示：联合用药组相较于K药单药组，疾病进展或死亡风险降低了65%（HR=0.35）。虽然中位PFS数据尚未成熟，但这一降幅已经显著超越了既往经典联合治疗研究所达到的水平。更"聪明"的是研究设计——不同于EVOKE-03只纳入PD-L1高表达（TPS≥50%）患者，OptiTROP-Lung05研究覆盖了所有PD-L1阳性人群（TPS≥1%），其中PD-L1低/中表达（TPS 1-49%）和高表达（TPS≥50%）的患者比例约为四六开。亚组分析显示，PD-L1低/中表达亚组的获益更为突出。这恰恰打在了K药的"软肋"上——K药单药在PD-L1低/中表达人群中的疗效相对有限，联合一个强力搭档才有更大的改善空间。 05 从分子设计看差异：为什么Sac-TMT更强？两款药物靶向同一个靶点，联合的是同一个免疫治疗药物，为何结果天差地别？答案藏在分子设计里。更稳定的连接子： Sac-TMT的连接子在体内更不容易提前断裂，这意味着载荷能在血液循环中保持"栓牢"状态，直到抵达肿瘤组织才释放。带来的直接好处有两个：一是血液中游离的载荷浓度更低，全身毒性（尤其是骨髓抑制和腹泻）显著减少；二是更多药物被递送到肿瘤内部，杀伤效率更高。更强的载荷： Trodelvy使用的是SN-38，Sac-TMT则采用了代号为KL610023的载荷——这是一种贝洛替康衍生物，同样靶向拓扑异构酶I，但细胞杀伤效力更强，半衰期也更长。这种设计理念的差异，直接反映在安全性数据上：Sac-TMT的血液学毒性和腹泻发生率远低于Trodelvy，其主要毒性表现为与靶点相关的"在靶毒性"，临床管理难度更小，患者的用药体验和治疗依从性自然也更好。简单来说，Trodelvy像是"导航系统还行但炸弹容易半路掉链子"，而Sac-TMT则是"导航精准、炸弹给力且保险绳更牢靠"。 06 默沙东的ADC版图：Sac-TMT的地位为何愈发重要？默沙东围绕K药打造的联合用药矩阵中，ADC是重要的战略方向。除了科伦博泰的Sac-TMT，2023年默沙东还与日本第一三共达成了一笔高达220亿美元的重磅合作，涉及HER3-DXd、I-DXd和R-DXd三款药物。但从目前的开发进展来看，Sac-TMT的重要性正在不断攀升： HER3-DXd虽然在治疗奥希替尼耐药后的EGFR突变非小细胞肺癌的III期研究中PFS达到了主要终点，但出现了2例致命的间质性肺炎（5级ILD），今年5月已主动撤回上市申请。这一安全性挫折显然影响了其后续开发节奏。 I-DXd目前主要集中在小细胞肺癌和前列腺癌领域的探索，在非小细胞肺癌方面仅有早期临床数据。 R-DXd的开发重心则在卵巢癌领域。此外，虽然默沙东也在参与第一三共/阿斯利康的T-DXd（靶向HER2的ADC）联合K药在肺癌领域的DESTINY-Lung06和TROPION-Lung08研究，但这些试验的主导权在第一三共/阿斯利康手中，T-DXd也并不在默沙东自己的产品矩阵内。此消彼长之下，Sac-TMT几乎成了默沙东在一线非小细胞肺癌领域最倚重的ADC伙伴。目前，默沙东已经布局了两项以"K药+Sac-TMT"为核心的III期大临床： TroFuse-007：针对PD-L1高表达（TPS≥50%）的转移性非鳞状非小细胞肺癌患者，预计2028年完成； TroFuse-023：针对转移性鳞状非小细胞肺癌患者的维持治疗，覆盖所有PD-L1表达水平。这两项研究瞄准的都是一线非小细胞肺癌的大适应症人群，足见默沙东对这一组合的信心。值得注意的是，全球III期设计并未采用中国研究中PD-L1 TPS≥1%的入组标准，而是分别针对特定人群精准出击——这或许既是对两款药物协同效应的信心，也是在K药核心适应症专利到期日渐临近的背景下，未雨绸缪、巩固优势的策略考量。 07 这对行业意味着什么？ Trodelvy在肺癌领域的连续失利，并不意味着ADC这条路走不通，而是提醒我们：ADC不是简单的"抗体+毒素"拼盘，连接子的稳定性、载荷的选择、适应症的差异化定位，每一个细节都决定成败。对中国创新药企而言，Sac-TMT的成功是一个极具意义的信号。它证明中国本土研发的创新药物，在分子设计和临床开发策略上，完全有能力做到全球领先水平，甚至在同靶点竞争中后来居上。与此同时，这一事件也在重塑一线非小细胞肺癌的未来竞争格局。随着K药专利悬崖的逼近，默沙东迫切需要找到能够延长其产品生命周期的黄金搭档。在这个叙事中，Sac-TMT正从"重要选项"逐步走向"C位主角"。在ADC药物竞争日趋白热化的今天，科学设计的力量正在重新定义谁是真正的赢家。免责声明本公众号专注收集发布全球生物医药行业资讯。本文仅作信息交流之目的，本文中所涉及的信息旨在科普，部分内容为AI生成，文中观点仅具有参考价值，不对所包含内容的准确性、可靠性或者完整性提供任何明示或暗示的保证。亿药前谈扫描二维码，关注更多生物医药资讯

抗体药物偶联物临床3期

2026-05-28

·BioSpace

Daiichi Sankyo Showcases Progress Across Industry-Leading Oncology Portfolio with Latest Research Updates at ASCO

New analyses from five landmark trials of Enhertu® and Datroway® in breast and gastric cancer alongside pipeline data across other tumor types demonstrate continued oncology leadership Early phase trials-in-progress featuring potential medicines with novel mechanisms highlight the company’s commitment to identifying new breakthrough generating technologies for patients with cancer TOKYO--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 25 abstracts in multiple cancers at the 2026 American Society of Clinical Oncology Annual Meeting (#ASCO26). Data at ASCO will highlight the company’s progress toward advancing new standards of care for patients with cancer, including new analyses from five landmark trials in breast and gastric cancer, including the DESTINY-Breast05 (# 516 ), DESTINY-Breast06 (# 1063 ), DESTINY-Breast09 (# 1021 ) and DESTINY-Gastric04 (# 4111 ) phase 3 trials of Enhertu ® (trastuzumab deruxtecan), and the TROPION-Breast02 (# 1002 ) phase 3 trial of Datroway ® (datopotamab deruxtecan). Additional results from earlier phase trials as well as trials-in-progress across new medicines being developed through the company’s breakthrough generating technology (BGT), a platform-based drug discovery model designed to deliver innovative medicines to patients faster, will be highlighted. Data from DESTINY-Breast05 formed the basis of one of two new Enhertu indications recently approved in the U.S. for certain patients with early-stage HER2 positive breast cancer and data from DESTINY-Gastric04 was included as part of a label update to expand the use of Enhertu in Japan and China to include the second-line treatment of patients with HER2 positive metastatic gastric cancer. Additionally, results from TROPION-Breast02 formed the basis of the recent U.S. approval of Datroway in patients with metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy, the first antibody drug conjugate (ADC) to be approved in this setting of TNBC. “The approvals received just prior to ASCO for Enhertu and Datroway, two of our leading DXd antibody drug conjugates, together with the strong science being showcased across our pipeline, highlight the momentum of our oncology portfolio,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “Daiichi Sankyo is committed to creating new standards of care for patients with cancer and continues to leverage its scientific and technological expertise to advance innovation.” Additional Enhertu Data Spans Broad Range of HER2 Expressing Cancers Additional research updates across several additional HER2 expressing cancers include oral and poster sessions highlighting the preliminary safety run-in results from the DESTINY-Ovarian01 (# 5554 ) phase 3 trial evaluating Enhertu in combination with bevacizumab compared to bevacizumab monotherapy as a first-line maintenance therapy in patients with HER2 expressing ovarian cancer; the primary analysis from part 1 of the DESTINY-PanTumor03 (# 3026 ) phase 2 trial evaluating Enhertu in pretreated patients in China with HER2 positive (IHC 3+) solid tumors (excluding breast and gastric cancer); and, findings from the MYTHOS (# 6011 ) phase 2 trial evaluating Enhertu in patients with HER2-low recurrent or metastatic salivary gland cancer. Additional breast and gastric cancer data for Enhertu include an oral presentation from one arm of the DESTINY-Breast07 (# 1012 ) phase 1b/2 trial evaluating Enhertu in combination with durvalumab as a first-line treatment in patients with HER2 positive metastatic breast cancer and a poster presentation highlighting a safety analysis from the DESTINY-Gastric03 (# 4022 ) phase 1b/2 trial evaluating Enhertu in combination with chemotherapy and immunotherapy as a first-line treatment in patients with HER2 expressing metastatic gastric cancer, gastroesophageal junction (GEJ) adenocarcinoma or esophageal adenocarcinoma. Results from cohort two of the EPOC2203 (# 4024 ) phase 1b/2 trial evaluating Enhertu in combination with nivolumab and capecitabine and oxaliplatin in patients with HER2 low gastroesophageal adenocarcinoma and an exploratory analysis of translational data from the EPOC2003 (# 3129 ) phase 2 trial evaluating neoadjuvant chemotherapy in combination with Enhertu in patients with HER2 positive gastric cancer will be highlighted as poster presentations. New Data and Trials-in-Progress Presentations Across Oncology Portfolio Poster presentations will include a trial-in-progress update of REJOICE-Ovarian01 ( TPS5637 ) for the phase 3 part of a phase 2/3 trial evaluating raludotatug deruxtecan (R-DXd) compared to treatment of physician’s choice in patients with platinum-resistant ovarian cancer. Two additional poster presentations will highlight an exposure-response analysis (# 5570 ) and a population pharmacokinetic analysis (# 5571 ) of data from both the REJOICE-Ovarian01 phase 2/3 trial and the phase 1 trial evaluating raludotatug deruxtecan in patients with advanced ovarian cancer or renal cell carcinoma. An oral presentation will highlight results from a phase 1/2 trial (# 6504 ) of Vanflyta® (quizartinib) plus decitabine and venetoclax in patients with newly diagnosed or relapsed/refractory FLT3 -ITD acute myeloid leukemia. Trials-in-progress poster presentations across the DXd ADC portfolio include the TROPION-Urothelial03 ( TPS4642 ) phase 2/3 trial evaluating Datroway and platinum chemotherapy compared to gemcitabine plus platinum chemotherapy in patients with locally advanced or metastatic urothelial carcinoma; the HERTHENA-Breast04 ( TPS1149 ) phase 3 trial evaluating patritumab deruxtecan (HER3-DXd) compared to treatment of physician’s choice in patients with HR positive, HER2 negative unresectable locally advanced or metastatic breast cancer; and the DESTINY-PanTumor04 ( TPS11202 ) hybrid observational trial evaluating Enhertu in patients with HER2 positive (IHC 3+) solid tumors. Trials-in-Progress Presentations Highlight Breakthrough Generating Technology Focus Daiichi Sankyo is leveraging its strength in science and technology to create new medicines for patients with cancer through its BGT approach which is designed to deliver innovative medicines to patients faster and with a higher probability of success. Trials-in-progress poster presentations featuring three potential new medicines include DS3610 ( TPS3159 ), a STING (stimulator of interferon genes) ADC, in patients with advanced or metastatic solid tumors; DS5361 ( TPS2680 ), a small-molecule, nonsense-mediated mRNA decay inhibitor, in patients with advanced or metastatic solid tumors; and, DS9051 ( TPS3179 ), a novel targeted protein degradation molecule, in patients with advanced or metastatic adrenocortical carcinoma or metastatic castration-resistant prostate cancer. Overview of clinical data and trials-in-progress from oncology pipeline of Daiichi Sankyo include: Presentation Title Author Abstract Presentation (CDT) Breast A DESTINY-Breast09 analysis of treatment duration and clinical outcomes by best response to trastuzumab deruxtecan (T-DXd) + pertuzumab Y. Park 1021 Rapid Oral Presentation Sunday, May 31 11:30 am – 1:00 pm Secondary safety analysis of trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in DESTINY-Breast05: clinical and demographic risk factors of interstitial lung disease and radiation pneumonitis M. Untch 516 Rapid Oral Presentation Monday, June 1 9:45 – 11:15 am Neoadjuvant rilvegostomig (R) + trastuzumab deruxtecan (T-DXd) in high-risk HER2-negative breast cancer: Results from the I-SPY 2.2 trial C. O’Sullivan LBA514 Rapid Oral Presentation Monday, June 1 9:45 – 11:15 am Trastuzumab deruxtecan (T-DXd) + durvalumab in patients with previously untreated HER2 positive unresectable/metastatic breast cancer (mBC): final analysis from DESTINY-Breast07 S. Loi 1012 Oral Presentation Sunday, May 31 8:30 – 10:00 am First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option: additional efficacy endpoints from the TROPION-Breast02 study D. Cescon 1002 Oral Presentation Tuesday, June 2 9:45 am – 12:45 pm Impact of adherence to interstitial lung disease (ILD)/pneumonitis toxicity management guidelines on ILD/pneumonitis outcomes: a retrospective analysis of patients treated with trastuzumab deruxtecan (T-DXd) in DESTINY-Breast06 C. Mateo 1063 Poster Session Monday, June 1 1:30 – 4:30 pm HERTHENA-Breast04: a phase 3, randomized, open-label study evaluating the efficacy and safety of patritumab deruxtecan (HER3-DXd) versus treatment of physician’s choice in hormone receptor positive (HR +)/HER2-) unresectable locally advanced or metastatic breast cancer B. Pistilli TPS1149 Poster Session Monday, June 1 1:30 – 4:30 pm Identifying patients with human epidermal growth factor receptor 2 (HER2) low and ultralow breast cancer: use of digital, artificial intelligence-based computational algorithms to assist HER2 scoring by pathologists S. Krishnamurthy 1022 Poster Session Monday, June 1 1:30 – 4:30 pm Gastric Additional health-related quality of life analysis from DESTINY-Gastric04, a randomized phase 3 study of trastuzumab deruxtecan (T-DXd) vs ramucirumab + paclitaxel in patients with HER2 positive unresectable/metastatic gastric cancer/gastroesophageal junction adenocarcinoma K. Shitara 4111 Poster Session Saturday, May 30 9:00 am – 12:00 pm First-line trastuzumab deruxtecan (T-DXd)-based regimens in advanced HER2 expressing gastric cancer, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma: safety results from DESTINY-Gastric03 Part 2 arms D and F, and Part 4 Y. Janjigian 4022 Poster Session Saturday, May 30 9:00 am – 12:00 pm An open-label phase 1b/2 study of trastuzumab deruxtecan combined with nivolumab and CAPOX in patients with HER2 low gastroesophageal adenocarcinoma (EPOC2203) Y. Aoki 4024 Poster Session Saturday, May 30 9:00 am – 12:00 pm Tumor and immune microenvironment remodeling with neoadjuvant trastuzumab deruxtecan in HER2 positive gastric cancer: exploratory analyses from the phase 2 EPOC2003 study A. Kawazoe 3129 Poster Session Saturday, May 30 1:30 – 4:30 pm Ovarian Trastuzumab deruxtecan (T-DXd) + bevacizumab (BEV) as first-line (1L) maintenance therapy in patients with HER2 expressing ovarian cancer: results from the DESTINY-Ovarian01 safety run-in A. Gonzalez Martin 5554 Poster Session Monday, June 1 9:00 am – 12:00 pm REJOICE-Ovarian01: phase 3 part of a phase 2/3 study evaluating raludotatug deruxtecan (R-DXd) versus treatment of physician’s choice in patients with platinum-resistant ovarian cancer D. Richardson TPS5637 Poster Session Monday, June 1 9:00 am – 12:00 pm Exposure-response analyses of efficacy and safety with raludotatug deruxtecan (R-DXd), a CDH6-directed ADC, to inform dose selection for phase 3 development in platinum-resistant ovarian cancer F. Hurtado 5570 Poster Session Monday, June 1 9:00 am – 12:00 pm Population pharmacokinetic analysis of raludotatug deruxtecan (R-DXd), a CDH6-directed ADC, in patients with advanced ovarian cancer or renal cell carcinoma F. Hurtado 5571 Poster Session Monday, June 1 9:00 am – 12:00 pm Urothelial TROPION-Urothelial03: a phase 2/3 study of datopotamab deruxtecan (Dato-DXd) + platinum chemotherapy vs gemcitabine + platinum chemotherapy in participants with locally advanced or metastatic urothelial carcinoma with progression on or after enfortumab vedotin + pembrolizumab M. Galsky TPS4642 Poster Session Sunday, May 31 9:00 am – 12:00 pm Salivary Trastuzumab deruxtecan in patients with HER2 low recurrent/metastatic salivary gland carcinoma: results from the phase 2 MYTHOS trial I. Kinoshita 6011 Oral Presentation Monday, June 1 8:00 – 9:30 am AML Quizartinib in combination with decitabine and venetoclax for newly diagnosed and relapsed/refractory FLT3 mutated acute myeloid leukemia M. Yilmaz 6504 Oral Presentation Tuesday, June 2 9:45 am – 12:45 pm Pan Tumor Trastuzumab deruxtecan (T-DXd) for pretreated patients in China with HER2 IHC 3+ solid tumors: DESTINY-PanTumor03 Part 1 primary analysis Y. Zhang 3026 Poster Session Saturday, May 30 1:30 – 4:30 pm A pragmatic, hybrid observational study evaluating the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with HER2 IHC3+ solid tumors: DESTINY-PanTumor04 B. Monk TPS11202 Poster Session Monday, June 1 9:00 am – 12:00 pm HER2 independent antitumor and pharmacodynamic responses to trastuzumab deruxtecan in patients with advanced solid tumors S. Shin 3031 Poster Session Saturday, May 30 1:30 – 4:30 pm Topoisomerase 1 and DNA damage: pharmacodynamic responses and mechanism of trastuzumab deruxtecan in HER2-expressing advanced solid tumors D. Wilsker 3092 Poster Session Saturday, May 30 1:30 – 4:30 pm BGT A phase 1, first-in-human study of DS3610, a stimulator of interferon genes (STING) agonist ADC, in patients with advanced/metastatic solid tumors S. Koganemaru TPS3159 Poster Session Saturday, May 30 1:30 – 4:30 pm A phase 1, first-in-human study of DS5361, a small-molecule, nonsense-mediated mRNA decay inhibitor, in patients with advanced/metastatic solid tumors (Parts 1 and 2) S. Sen TPS2680 Poster Session Saturday, May 30 1:30 – 4:30 pm A phase 1, first-in-human study of DS9051, a novel targeted protein degradation molecule, in patients with advanced/metastatic adrenocortical carcinoma or metastatic castration-resistant prostate cancer M. Patel TPS3179 Poster Session Saturday, May 30 1:30 – 4:30 pm About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include Enhertu and Datroway, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo. An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit . Contacts MEDIA CONTACTS: Global: Jennifer Brennan jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) Japan: DS-PR_jp@daiichisankyo.com INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com

临床3期临床结果临床1期ASCO会议临床2期

100 项与 Raludotatug deruxtecan 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
铂耐药性输卵管癌	临床3期	美国	Daiichi Sankyo Co., Ltd.	2024-02-27
铂耐药性输卵管癌	临床3期	美国	Merck Sharp & Dohme LLC	2024-02-27
铂耐药性输卵管癌	临床3期	中国	Merck Sharp & Dohme LLC	2024-02-27
铂耐药性输卵管癌	临床3期	中国	Daiichi Sankyo Co., Ltd.	2024-02-27
铂耐药性输卵管癌	临床3期	日本	Daiichi Sankyo Co., Ltd.	2024-02-27
铂耐药性输卵管癌	临床3期	日本	Merck Sharp & Dohme LLC	2024-02-27
铂耐药性输卵管癌	临床3期	澳大利亚	Merck Sharp & Dohme LLC	2024-02-27
铂耐药性输卵管癌	临床3期	澳大利亚	Daiichi Sankyo Co., Ltd.	2024-02-27
铂耐药性输卵管癌	临床3期	巴西	Daiichi Sankyo Co., Ltd.	2024-02-27
铂耐药性输卵管癌	临床3期	巴西	Merck Sharp & Dohme LLC	2024-02-27

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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


NCT06161025 (REJOICE-Ovarian01, ASCO2026)	临床3期	铂耐药性卵巢癌 CDH6 expression	600	R-DXd 5.6 mg/kg	艱窪繭齋窪膚艱製夢淵(鏇膚鏇鏇艱鹹壓鏇廠廠) = 遞鑰憲獵範餘鬱齋網願選繭範壓顧憲餘簾襯鏇 (鬱醖醖繭獵夢鬱餘壓淵, 42.9 ~ 57.1) 更多	积极	2026-05-29
NCT04707248 (REJOICE-Ovarian01, ASCO2026)	临床1/2期	铂耐药性卵巢癌 CDH6 expression	286	Raludotatug deruxtecan 5.6 mg/kg Q3W	鹹顧鬱壓構蓋衊構鹹鬱(鹽醖鹹醖遞淵壓獵鬱齋) = Higher R-DXd or DXd payload exposure was associated with an increase in drug-related TEAEs, including Grade ≥3 (G3+) AEs, any-grade ILD, G2+ gastrointestinal AEs (nausea/vomiting), G3+ cytopenias (anemia, neutropenia, thrombocytopenia), and AEs leading to dose reduction. 襯蓋餘窪壓繭簾築衊築 (餘鹽餘蓋築齋齋壓遞糧 ) 更多	积极	2026-05-29
NCT04707248 (REJOICE-PanTumor01, ASCO_GU2026)	临床2期	泌尿生殖系统肿瘤 \| 妇科疾病 CDH6	40	R-DXd 5.6 mg/kg (Cervical Cancer)	壓網餘蓋網築鬱繭廠衊(廠餘簾憲夢願淵簾壓網) = 繭鏇鏇構鑰鏇簾簾簾鑰築鹹遞齋膚淵構醖鏇憲 (網簾範鹹窪鑰鏇衊鏇鹹 )	积极	2026-02-26
				R-DXd 5.6 mg/kg (Non-HGSOC)	壓網餘蓋網築鬱繭廠衊(廠餘簾憲夢願淵簾壓網) = 鏇顧繭繭廠淵顧築蓋築築鹹遞齋膚淵構醖鏇憲 (網簾範鹹窪鑰鏇衊鏇鹹 )
NCT06161025 (REJOICE-Ovarian01, ESMO 12025 \| ESMO 22025) 人工标引	临床2期	铂耐药性输卵管癌 \| 铂类耐药性原发性腹膜癌 \| 铂耐药性卵巢癌	107	R-DXd (4.8 mg/kg)	鏇鏇淵顧繭餘繭醖壓窪(鏇廠簾鑰壓積觸糧範鏇) = 構膚艱顧顧鬱繭製築糧繭選淵淵簾鏇糧獵餘製 (醖衊範鹽築餘夢製遞醖, 27.9 ~ 61.9) 更多	积极	2025-10-17
				R-DXd (5.6 mg/kg)	鏇鏇淵顧繭餘繭醖壓窪(鏇廠簾鑰壓積觸糧範鏇) = 積築積夢獵鏇鹹獵膚壓繭選淵淵簾鏇糧獵餘製 (醖衊範鹽築餘夢製遞醖, 32.9 ~ 67.1) 更多
NCT06780085 (KEYMAKER-U01, ESMO2025)	临床2期	转移性非小细胞肺癌	240	R-DXd 5.6 mg/kg Q3W	鹽艱構網艱顧簾顧淵鹽(願廠遞觸淵簾憲繭壓糧) = 積襯壓顧齋願網獵鏇餘襯範蓋糧鑰窪艱築獵餘 (齋壓獵顧齋遞積壓糧觸 )	积极	2025-10-17
				I-DXd 12 mg/kg Q3W	鹽艱構網艱顧簾顧淵鹽(壓觸鏇齋窪淵構艱簾鏇) = 網製獵憲艱壓獵遞襯鏇選壓顧餘觸窪淵積壓窪 (鬱衊窪獵壓壓製範選鬱 ) 更多
NCT04707248 (Corporate Publications) 人工标引	临床1期	卵巢癌	50	Raludotatug deruxtecan	鹽衊觸壓窪繭醖獵範築(簾獵獵醖艱糧蓋選鏇築) = 築選繭構鏇齋醖鏇鹹築願壓夢淵網膚夢艱鏇簾 (糧艱構構簾鑰艱積齋鏇, 32 ~ 61) 更多	积极	2023-10-22
NCT04707248 (ESMO 12023 \| ESMO 22023) 人工标引	临床1期	卵巢癌	42	R-DXd at 4.8 mg/kg	網廠窪糧膚選廠鹽醖構(淵憲網製夢蓋夢窪窪蓋) = 齋膚製廠鑰艱構蓋憲鹹糧範鹹夢淵願膚繭鹹鏇 (膚鏇遞遞構網齋鹹餘膚 ) 更多	积极	2023-10-22
				R-DXd at 6.4 mg/kg	網廠窪糧膚選廠鹽醖構(淵憲網製夢蓋夢窪窪蓋) = 範齋構鑰製築憲鹹製鏇糧範鹹夢淵願膚繭鹹鏇 (膚鏇遞遞構網齋鹹餘膚 ) 更多
NCT04707248 (ASCO2022) 人工标引	临床1期	卵巢癌 \| 晚期肾细胞癌	22	DS-6000a	簾窪夢艱鏇選壓網艱鬱(壓窪鏇獵齋選艱選觸遞) = 襯艱觸衊餘鑰壓淵醖顧鏇艱築膚觸餘壓鬱鑰鹽 (窪鏇夢積顧顧齋襯蓋繭 ) 更多	积极	2022-06-02