A Phase 3, Randomized, Open-label Study of Raludotatug Deruxtecan (MK-5909, R-DXd) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly-Diagnosed Advanced Non-HRD-Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (ENGOT-ov102/MITO/GOG-3141/ REJOICE-Ovarian 04)

Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:
Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread.
Observation, which is watching to see if cancer grows or worsens. The study medicine, raludotatug deruxtecan- R-DXd, is a targeted therapy. The goal of this study is to learn if people who receive R-DXd maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.

开始日期2026-09-22

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT07743164

/ Not yet recruiting临床3期

A Phase 3, Open-Label, Multicenter, Randomized Study of Raludotatug Deruxtecan (MK-5909, R-DXd) With or Without Bevacizumab Versus Standard-of-Care Platinum-Based Doublet Chemotherapy With or Without Bevacizumab in Participants With Advanced Platinum-Sensitive High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Have Progressed During First-Line PARPi Maintenance (ENGOT-ov107 / GOG-3142 / REJOICE-Ovarian05)

Researchers are looking for new ways to treat advanced, high-grade ovarian cancer (OC). Advanced means the cancer has spread to other parts of the body (metastatic) and may not be removed with surgery. High-grade means the cancer cells grow and spread quickly. This trial includes types of OC that started in cells that cover the ovaries, in the lining of the belly, or in the fallopian tubes.
The usual treatment for high-grade OC may include one or both of these:
* Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing.
* Bevacizumab, which is a targeted therapy that works to control how specific types of cancer cells grow and spread and targets tumor blood vessels.
Researchers want to learn about the trial medicine, raludotatug deruxtecan (also called R-DXd or MK-5909), when given with and without bevacizumab and how participants respond to it. R-DXd is an antibody drug conjugate (ADC). An ADC is a type of medicine that attaches to a specific target on cancer cells and delivers treatment to destroy those cells.
The goals of this trial are to learn if participants who receive R-DXd, with or without bevacizumab, live longer overall and without their cancer growing or spreading compared to those who receive usual treatment.

开始日期2026-07-17

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT06780098

/ Recruiting临床2期

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]

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

389

项与 Raludotatug deruxtecan 相关的新闻（医药）

2026-08-27

·BioSpace

DS1025 Enters Clinical Development in Patients with Advanced Solid Tumors as Novel CD25 Directed ADC in Industry-Leading ADC Portfolio of Daiichi Sankyo

TOKYO--(BUSINESS WIRE)--The first patient has been dosed in a first-in-human phase 1 trial evaluating DS1025 in adult patients with advanced or metastatic solid tumors with disease progression on or after at least one prior line of standard therapy. DS1025 is a specifically engineered, investigational, potential first-in-class CD25 directed antibody drug conjugate (ADC) containing an immuno-oncology optimized cytotoxic payload discovered by Daiichi Sankyo (TSE:4568). CD25 is a cell surface protein that is highly expressed on regulatory T cells (Treg cells) which suppresses the response of the immune system against cancer, 1 making it a promising therapeutic target. Currently, there are no CD25 directed ADCs approved for any type of cancer. “While immunotherapies have transformed cancer treatment, continued innovation in leveraging pathways that can activate the immune system is needed,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “The initiation of this trial evaluating DS1025 reflects continued progress in advancing our pipeline through the development of novel antibody drug conjugates in order to deliver medicines that improve outcomes for patients with cancer.” About the Phase 1 Trial The multicenter, open-label, first-in-human, dose escalation phase 1 trial will assess the safety, tolerability, pharmacokinetics and preliminary efficacy of DS1025 in patients with advanced or metastatic solid tumors with disease progression on or after at least one prior line of standard therapy. The trial will evaluate primary endpoints of safety and tolerability, including dose-limiting toxicities and adverse events. Secondary endpoints include pharmacokinetics and immunogenicity. Exploratory endpoints include overall response rate, duration of response and time to response. The trial is expected to enroll up to 45 patients across multiple sites in Asia and Europe. For more information, please visit ClinicalTrials.gov . About CD25 CD25 is a cell surface protein that is highly expressed on regulatory T cells (Treg cells). Treg cells work to suppress the immune system, helping tumors evade the body’s natural ability to destroy abnormal cells and are thought to be a key contributor to resistance that develops with currently available immunotherapies. 2 About DS1025 DS1025 is an investigational, potential first-in-class CD25 directed ADC that builds on the DXd ADC Technology of Daiichi Sankyo by delivering an immuno-oncology optimized cytotoxic payload that works to deplete immunosuppressive T cells (Treg cells) in the tumor microenvironment and activate the immune system to detect and destroy cancer cells. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of nine 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. DS3939 and DS3790 are being developed by Daiichi Sankyo. Additional ADCs being developed by Daiichi Sankyo include DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING, and DS1025, which consists of a CD25 directed antibody attached to an immuno-oncology optimized cytotoxic payload. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS3939, DS3610, DS3790 and DS1025 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 . REFERENCES: 1 Sureka N, et al. Cell Biol Int . 2025;49(8):897-928. 2 Fares C, et al. Am Soc Clin Oncol Educ Book . 2019 Jan;39:147-164. 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

抗体药物偶联物免疫疗法临床1期

2026-08-26

·今日头条

【注册报告】2026年7月药品注册受理与审评审批分析报告

药品注册审批月报（2026年7月）统计周期：2026年7月1日—7月31日查询时间：2026年8月1日。数据可能动态更新，请以官方最新公示为准。本月CDE受理2188个受理号，化药占比49.7%，1类创新药195个（化药）；NMPA批准上市395个（化药新药1个、生物类似药2个、中药新药1个）。一、受理概况药品类型受理号数占比化药 1,087 49.7% 中药 732 33.5% 生物制品 369 16.9% 合计 2,188 100% *注：生物制品含治疗用344个、预防用20个、未细分5个。二、化药受理 2.1 按申请类型分布 2.2 按注册分类分布（仅新药+进口+仿制，共601个） *注：2.2,2.4（4个）和2.22.4（2个）已合并计入对应类别。 2.3 化药1类创新药（新药+进口，部分代表性品种）药品名称申请类型企业名称承办日期 YF550片新药益祺生物 07-01 HS-10582片新药翰森/豪森 07-01 注射用PTT-121 新药北京炎明生物 07-01 AHB-137注射液新药杭州浩博 07-01 MDR-001片新药杭州德睿智药 07-02 QLS1510片新药齐鲁制药 07-02 注射用JY1001 新药浙江杭煜 07-02 AZD6234注射液进口阿斯利康 07-03 PF-08653944注射液进口辉瑞 07-03 AZD5305 进口阿斯利康 07-03 SYH2083滴眼液新药上海翊石 07-03 VV147片新药旺山旺水 07-06 FXS5626片新药复星医药 07-06 Rinzimetostat 进口 ORIC Pharma 07-02 *化药1类（含新药+进口）共195个受理号，上表为部分代表性品种。 2.4 重点品种 HS-10582片（翰森制药/豪森药业） - 化药1类新药，具体靶点与适应症待后续披露。本品为翰森自主研发的小分子创新药，7月1日首次提交IND申请。 - 翰森是国内头部创新药企，管线覆盖肿瘤、自免、代谢等领域，2026年以来已有多款1类新药进入临床。 - 本次承办日期：2026-07-01，申请类型：新药IND。 AZD6234注射液（阿斯利康） - 化药1类进口药，为阿斯利康全球在研的长效Amylin类似物，拟用于肥胖/超重适应症。AZD6234作为单药或联合疗法在海外已推进至II期临床。 - 2026年7月3日，阿斯利康在中国一次性提交12个规格的IND申请，涵盖不同剂量组，显示其在中国临床开发力度。 - 本次承办日期：2026-07-03，申请类型：进口IND。三、生物制品受理本月生物制品受理369个，治疗用344个，预防用20个，一次性进口5个。 3.1 治疗用生物制品1类新药（部分代表性品种）药品名称企业名称承办日期注射用VDJ010 北京伟德杰 07-01 NW-301V注射液新景智源 07-01 乐德奇拜单抗注射液先声药业 07-02 CM313(SC)注射液康诺亚 07-03 CM336注射液康诺亚 07-03 CM529D1 康诺亚 07-06 DS-6000a 第一三共 07-03 DS-1103a 第一三共 07-08 DS-3939a 第一三共 07-08 Telisotuzumab Adizutecan AbbVie 07-08 注射用HS-20197 翰森/常州恒邦 07-09 GenSci148注射液长春金赛 07-07 BA1203注射液山东博安 07-08 AZD7003 阿斯利康 07-08 LBL-034注射液南京维立志博 07-08 SYS6043 石药巨石 07-08 注射用SHR-4595 苏州盛迪亚 07-07 *1类生物制品（新药+进口）共约174个受理号，康诺亚、第一三共、翰森等企业密集申报。 3.2 进口生物制品上市申请（NDA/BLA）药品名称注册分类企业名称承办日期帕博利珠单抗注射液 2.2 MSD(默沙东) 07-01 注射用维恩妥尤单抗 2.2 Astellas(安斯泰来) 07-06 纳武利尤单抗注射液 3.1 BMS(百时美施贵宝) 07-09 3.3 重点品种：乐德奇拜单抗注射液（先声药业） - 治疗用生物制品1类新药，为先声药业自主研发的单克隆抗体，靶向IL-4Rα（推测），拟用于特应性皮炎等自免疾病。本品于2026年7月2日提交IND申请（2个规格）。 - 先声药业近年来在自免领域持续投入，此前已有多个生物创新药进入临床阶段。 - 本次承办日期：2026-07-02，申请类型：新药临床申请。四、中药受理中药受理732个，补充申请710个，新药18个（IND 12个、NDA 6个），一次性进口4个，仿制药0个。 4.1 中药新药列表药品名称申请类型注册分类企业名称承办日期柴芍肠宁颗粒 IND 1.1 玉森(佛山) 07-02 糖宁通络乳膏 IND 1.1 百灵毓秀 07-13 ZYY-757颗粒 IND 1.1 扬子江龙凤堂 07-15 CHA756丸 IND 1.1 诺贝生物 07-23 TDX105颗粒 IND 1.1 天士力 07-27 藿连消滞颗粒 IND 1.1 和光中药 07-31 复方野菊花颗粒 IND 1.1 浙江中医药大学 07-31 塞络通胶囊 NDA 1.1 神威药业 07-30 注射用和厚朴酚脂质体冻干粉 IND 1.2 北京金瑞基业 07-08 骨龙胶囊 IND 2.3 东阿阿胶 07-01 季德胜蛇药片 IND 2.3 精华制药 07-17 舒筋健腰丸 IND 2.3 白云山陈李济 07-23 银杏二萜内酯滴丸 IND 2.12.22.3 江苏康缘 07-23 桃红四物汤颗粒 NDA 3.1 株洲千金 07-02 当归饮子颗粒 NDA 3.1 海南斯达 07-13 温经汤颗粒 NDA 3.1 山东齐都 07-21 当归四逆汤颗粒 NDA 3.1 广东经典名方 07-28 桃红四物颗粒 NDA 3.1 国药广东环球 07-28 *亮点：塞络通胶囊（神威药业，1.1类NDA）为中药创新药直接申报上市；古代经典名方3.1类集中申报5个品种（桃红四物汤、当归饮子、温经汤、当归四逆汤、桃红四物），显示经典名方研发热度持续。本月无中药仿制药。五、药品上市 NMPA批准上市药品395个（批准文号/受理号计），化药约390个（新药1个、仿制药约385个、进口1个），生物制品2个，中药1个。 5.1 重点获批品种药品名称注册分类企业名称批准日期左乙拉西坦缓释颗粒 2.2(化药新药) 浙江赛默 07-14 利拉鲁肽注射液 3.3(生物类似药) 重庆宸安 07-08 注射用奥马珠单抗 3.3(生物类似药) 远大蜀阳 07-28 五味消毒饮颗粒 3.1(中药经典名方) 瑞阳制药 07-21 他达拉非片 5.2(进口仿制) Sawai(日本) 07-08 5.2 重点品种详情左乙拉西坦缓释颗粒（浙江赛默制药，化药2.2类改良型新药） - 企业：浙江赛默制药有限公司。左乙拉西坦为第二代广谱抗癫痫药物，缓释颗粒剂型可改善儿童及吞咽困难患者的服药依从性，属改良型新药（2.2类）。 - 本品于2024年8月23日承办（CXHS2400081），以NDA路径申报，2026年7月14日获批生产，审评周期约23个月。 - 左乙拉西坦国内已有片剂、口服溶液、注射剂等多种剂型，缓释颗粒为首家获批，差异化优势明显。利拉鲁肽注射液（重庆宸安生物制药，3.3类生物类似药） - 企业：重庆宸安生物制药有限公司。利拉鲁肽为GLP-1受体激动剂，原研诺和诺德，适应症为2型糖尿病及肥胖。本品为生物类似药（3.3类）。 - 2024年12月3日承办（CXSS2400132），以"上市"通道申报，2026年7月8日获批生产，审评周期约19个月。 - GLP-1赛道国内竞争激烈，利拉鲁肽生物类似药已有华东医药、通化东宝等获批，重庆宸安为又一家获批企业。注射用奥马珠单抗（远大蜀阳生命科学，3.3类生物类似药） - 企业：远大蜀阳生命科学（成都）有限公司，委托澳斯康生物（南通）生产。奥马珠单抗为抗IgE单克隆抗体，原研诺华/罗氏，用于中重度过敏性哮喘及慢性自发性荨麻疹。 - 2024年12月31日承办（CXSS2400143），2026年7月28日获批生产，审评周期约19个月。 - 国内奥马珠单抗生物类似药此前已有石药集团巨石生物获批，远大蜀阳为第二家。六、CDE文件/公告/新闻（7月） 1. 《药品审评书面发补标准》征求意见（07-24） CDE发布征求意见稿，统一发补要求，规定14种允许发补情形，旨在严控发补次数、提高审评效率。 https://www.cde.org.cn 2. 《原发免疫性血小板减少症创新药临床研发技术指导原则》征求意见（07-24） CDE公开征求ITP创新药临床研发技术指导原则意见，推动罕见血液病药物研发规范化。 https://www.cde.org.cn 3. CDE"先锋计划"征求意见：推进NAMs研究和应用（07-07）就"推进新方法（NAMs）研究和应用试点计划"公开征求意见，类器官和器官芯片正式进入监管审评通道，标志中国药物非临床评价迈向"去动物化"。 https://www.cde.org.cn 4. 国家药监局发布CGT审评审批优化公告征求意见（07-03）拟将细胞与基因治疗药品纳入30日审评通道，政策红利从"沟通环节"延伸至"审评审批全链条"。 https://www.nmpa.gov.cn 5. 药审中心召开鼓励和促进抗结核创新药物临床研发技术研讨会（07-15）聚焦抗结核新药研发难点，推动该领域创新药的临床开发。 https://www.cde.org.cn 想查更多？药达·isearch 免费体验文末「阅读原文」直达戊戌数据 · 注册报告数据来源：药达isearch（https://isearch.wuxuwang.com）戊戌数据（www.wuxuwang.com）内容仅供参考，不构成投资或用药建议 END

2026-08-21

·医药笔记

默沙东：CDH6 ADC启动卵巢癌三期临床

▎Armstrong 2026年8月20日，默沙东在Clinicaltrials.gov网站上注册了CDH6 ADC新药R-DXd的首个三期临床试验REJOICE-Ovarian 04，用于一线维持治疗晚期卵巢癌。该三期临床计划入组802例晚期卵巢癌患者，预计2032年3月初步完成。 R-DXd同步在开展多项早期临床，此前已经启动二线或以上治疗铂耐药卵巢癌的全球2/3期临床REJOICE-Ovarian01。第一三共计划今年下半年ESMO会议上公布REJOICE-Ovarian01的二期临床部分的最新数据。总结默沙东预期2028年完成REJOICE-Ovarian01注册临床，满足申报上市需求。CDH6为FRα之后卵巢癌领域又一个潜在的重要靶点。国内方面，拓济医药的FRα/CDH6双毒素ADC新药TJ102已经申报IND，即将进入临床试验阶段。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

100 项与 Raludotatug deruxtecan 相关的药物交易

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研发状态

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
HRD 阳性卵巢癌	临床3期	-	Merck Sharp & Dohme LLC	2026-09-22
卵巢浆液性肿瘤	临床3期	-	Daiichi Sankyo Co., Ltd.	2026-09-01
铂敏感性输卵管癌	临床3期	-	Merck Sharp & Dohme LLC	2026-07-17
铂敏感性卵巢癌	临床3期	-	Merck Sharp & Dohme LLC	2026-07-17
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	美国	Daiichi Sankyo Co., Ltd.	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	Merck Sharp & Dohme LLC	2024-02-27
铂耐药性输卵管癌	临床3期	日本	Daiichi Sankyo Co., Ltd.	2024-02-27

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临床结果

适应症

分期

评价

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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	醖簾餘遞壓壓範蓋鹽齋(願範醖襯製襯繭壓餘網) = 衊窪鹽築觸淵網糧觸淵鏇窪遞糧壓製製構願築 (鏇鬱範範觸願鏇艱艱選, 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	壓築網窪鬱選膚積膚鏇(衊鑰簾壓構餘簾窪鏇蓋) = 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. 鬱夢構顧構網壓壓選鬱 (構築積範鬱齋觸鏇範構 ) 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)	壓壓獵顧鏇觸網憲遞餘(壓鹹糧衊衊鹽憲廠壓夢) = 壓觸鏇醖艱製鑰窪鏇蓋願顧願繭鹽範膚觸構獵 (積鬱簾構鹹鑰蓋願遞顧 )	积极	2026-02-26
				R-DXd 5.6 mg/kg (Non-HGSOC)	壓壓獵顧鏇觸網憲遞餘(壓鹹糧衊衊鹽憲廠壓夢) = 齋網顧願鏇夢夢鑰網壓願顧願繭鹽範膚觸構獵 (積鬱簾構鹹鑰蓋願遞顧 )
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)	網淵選鹽鹹遞積夢繭遞(齋獵餘簾鹽醖網願襯願) = 製廠築觸簾醖憲獵鹹鑰餘淵顧範鏇築構鏇餘積 (艱觸獵壓鏇築選膚構鏇, 27.9 ~ 61.9) 更多	积极	2025-10-17
				R-DXd (5.6 mg/kg)	網淵選鹽鹹遞積夢繭遞(齋獵餘簾鹽醖網願襯願) = 獵獵鏇襯獵構觸齋襯蓋餘淵顧範鏇築構鏇餘積 (艱觸獵壓鏇築選膚構鏇, 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	築範醖選繭憲窪夢網遞(鬱齋網製衊繭顧鬱鏇範) = 鬱膚蓋網衊齋願繭選築鏇鏇獵範鏇窪窪襯蓋窪 (積鬱膚鹹顧淵壓憲鹹鑰 )	积极	2025-10-17
				I-DXd 12 mg/kg Q3W	築範醖選繭憲窪夢網遞(製鬱鏇膚簾鑰製觸鏇積) = 築構範襯選製觸艱醖膚憲製範範壓衊糧築願鏇 (鹹獵蓋衊願獵齋衊夢艱 ) 更多
NCT04707248 (Corporate Publications) 人工标引	临床1期	卵巢癌	50	Raludotatug deruxtecan	廠膚網衊構餘網網構鏇(廠壓餘鏇構獵淵艱遞願) = 製鏇鏇蓋觸選艱範衊襯網簾鹽夢鏇觸鏇觸憲鏇 (膚憲築鏇鏇鑰醖艱繭膚, 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	遞簾積願製網鹹膚鹽遞(壓糧艱憲壓醖齋築衊積) = 淵積願窪積鹽製鏇齋餘衊遞遞觸簾網襯簾構鏇 (膚範觸淵壓簾夢蓋餘憲 ) 更多	积极	2023-10-22
				R-DXd at 6.4 mg/kg	遞簾積願製網鹹膚鹽遞(壓糧艱憲壓醖齋築衊積) = 製艱壓遞範壓鬱蓋襯簾衊遞遞觸簾網襯簾構鏇 (膚範觸淵壓簾夢蓋餘憲 ) 更多
NCT04707248 (ASCO2022) 人工标引	临床1期	卵巢癌 \| 晚期肾细胞癌	22	DS-6000a	齋獵衊獵鏇鏇膚淵網窪(淵獵淵遞選廠膚醖觸齋) = 廠餘壓鏇襯膚艱鏇艱築壓構憲範顧網繭襯蓋網 (製淵製繭鹽襯淵構觸鏇 ) 更多	积极	2022-06-02