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: Yin, Sicheng ; Liu, Shuangxi ; Zhang, Yifan ; Zhang, Wenbo ; Yang, Tong ; 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 ; 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·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.

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 ; Guo, Qingsong ; Xie, Qian ; 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.

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项与 Raludotatug deruxtecan 相关的新闻（医药）

2025-10-29

·默沙东中国

默沙东与第一三共在2025欧洲肿瘤内科学会（ESMO）年会发布II/III期REJOICE-Ovarian01研究II期研究进展

默沙东与第一三共在2025欧洲肿瘤内科学会（ESMO）年会发布II/III期REJOICE-Ovarian01研究II期研究进展美国新泽西州巴斯金里奇与罗威市，2025年10月19日——I/III期REJOICE-Ovarian01研究在2025欧洲肿瘤内科学会（ESMO）年会公布II期研究剂量优化部分数据，评估raludotatug deruxtecan[1]（R-DXd）用于铂耐药高级别卵巢癌、原发性腹膜癌或输卵管癌患者。该数据在2025ESMO最新摘要专场会议上发布（LBA42）。 Raludotatug deruxtecan是一款专门设计、潜在首创的靶向CDH6的DXd抗体偶联药物（ADC），由第一三共发现，并与默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号）联合开发。 Isabelle Ray-Coquard博士欧洲妇科肿瘤试验网络（ENGOT）主席卵巢癌及乳腺癌临床研究者国家协作组（GINECO）研究负责人法国里昂莱昂贝拉尔中心肿瘤科医生 “ 当卵巢癌对铂类化疗产生耐药后，患者的治疗选择变得有限，REJOICE-Ovarian01研究分享的结果提示了raludotatug deruxtecan有望在铂耐药卵巢癌患者的治疗中的重要角色，并支持在III期研究中进一步评估。 ” Ken Takeshita博士第一三共全球研发负责人 “ 在本次剂量优化分析结果促成了美国FDA近期授予的突破性疗法认定，进一步显示了raludotatug deruxtecan为部分铂耐药卵巢癌患者带来新选择的潜力。 ” Eliav Barr博士默沙东实验室全球临床开发高级副总裁首席医疗官 “ 近年来卵巢癌的靶向治疗取得进展，但患者仍有较高的未满足需求。CDH6在卵巢癌中高度表达，凸显了raludotatug deruxtecan的潜力。 ” 关于REJOICE-Ovarian01研究 REJOICE-Ovarian01是一项全球多中心、随机、开放标签的II/III期研究，评估raludotatug deruxtecan在铂耐药高级别卵巢癌、原发性腹膜癌或输卵管癌患者中的疗效和安全性。入组患者需在经1-3线系统治疗后疾病进展，研究允许纳入接受过mirvetuximab oravtansine治疗的高叶酸受体α表达的患者。维持治疗（如贝伐珠单抗、PARP抑制剂）视为前一线治疗的一部分。 REJOICE-Ovarian01研究的II期部分评估三种剂量（4.8 mg/kg、5.6 mg/kg、6.4 mg/kg）的安全性和耐受性，以确定III期推荐剂量。II期主要终点为BICR评估的ORR，次要终点包括研究者评估的ORR、缓解持续时间（DoR）、无进展生存期（PFS）和疾病控制率（DCR），均由BICR和研究者评估。 REJOICE-Ovarian01研究的III期部分将评估选定剂量（5.6 mg/kg）raludotatug deruxtecan与研究者选择的化疗（紫杉醇、脂质体阿霉素、吉西他滨或托泊替康）的疗效和安全性。III期双主要终点为BICR评估的ORR和PFS，次要终点包括研究者评估的PFS和ORR、DoR和DCR，以及总生存期（OS）。II期和III期部分均将评估药代动力学和生物标志物终点。 [1] 截至目前，raludotatug deruxtecan尚未获中国国家药品监督管理局（NMPA）批准若您想了解更多有关疾病知识的信息，请咨询医疗卫生专业人士 11-2025-CN-NON-00606 关于第一三共与默沙东的合作 2023年10月，第一三共与默沙东达成一项全球合作，除在日本第一三共保留独家权利外，共同对patritumab deruxtecan(HER3-DXd)，ifinatamab deruxtecan(I-DXd)和raludotatug deruxtecan(R-DXd)进行临床开发和商业推广。第一三共将全权负责产品生产和供应。2024年8月，双方进一步扩大了全球共同开发与商业推广合作，新增gocatamig（MK-6070/DS3280），除在日本默沙东保留独家权利外，双方将在全球范围内共同开发和推广该药物。默沙东将全权负责gocatamig的生产和供应。关于默沙东在默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号），我们齐心协力追求共同的目标：我们发挥前沿科学的力量，在全球范围内拯救生命、改善生活。130多年来，我们通过研发重要药物和疫苗，为全人类带来希望。我们致力成为顶尖的研究密集型生物制药公司——当下，我们正处于研发前线，推出创新解决方案，以推进人类和动物疾病的预防和治疗。我们建立了一个多元、包容的全球员工体系，以负责的态度经营每一天，确保所有人、所有社区都能有一个安全、可持续和健康的未来。更多信息，请访问www.msd.com，并在X（前身为Twitter）、LinkedIn和Youtube平台关注我们。关于默沙东中国中国是默沙东全球增长战略中至关重要的一部分。默沙东中国总部设在上海，同时在北京设有研发中心、在杭州、宁波和天津分别设有工厂，实现了研发、制造和商业运营三擎合一。我们全心全意，向中国大众提供高质量的创新药物、疫苗和服务，造福中国社会。更多信息，敬请访问默沙东中国官网，或关注默沙东中国在微信上的官方社交媒体账号。默沙东前瞻性声明默沙东是美国新泽西州罗威市默克公司的公司商号（下称“公司”）。本新闻稿包含根据《1995 年美国私人证券诉讼改革法案》之安全条款而做出的“前瞻性声明”。本文内容基于公司管理层当前的看法和预期，并且受制于可能出现的重大风险和不确定因素。默沙东不保证在研产品能获得所需的监管部门批准或取得商业成功。如果相关假设与现实有所出入、出现风险，或发生不确定情况，实际结果可与前瞻性声明中的预期有实质上的差异。风险和不确定因素包括但不仅限于一般行业情况与竞争、一般经济因素（包括利率与汇率浮动）、美国及其他国家制药行业监管以及医疗政策的影响、全球范围内控制医疗成本的趋势、技术发展、竞争对手获得的新产品与专利、新产品开发固有的挑战（包括获得监管部门批准）、默沙东对未来市场形势做出准确预测的能力、生产上的困难或迟延、国际经济金融状况不稳定与主权风险、对默沙东专利和其它创新产品保护的有效性的依赖程度，以及公司面临专利诉讼和/或监管行动的风险。默沙东没有义务就新信息、未来事件或其它原因对任何前瞻性声明进行公开的更新。尚有其它因素可能导致实际结果与前瞻性声明存在实质性差异，请参见默沙东2024年年报10-K报表以及公司在美国证券交易所备案的其它文件（可在美国证券交易所网站www.sec.gov上查阅）。

临床2期临床结果抗体药物偶联物突破性疗法临床成功

2025-10-27

·泽桥医学服务

一周药闻：跨国药企竞相布局中国创新药，ADC 领域合作与研发成果成 ESMO 焦点

导言近期，武田、罗氏、默克等跨国药企与中国生物科技公司达成多项高额授权交易，涉及前沿的ADC药物技术。在欧洲肿瘤内科学会（ESMO）大会上，这些合作成果集中展示，相关临床试验数据积极，推动药物进入关键研发阶段。一周药闻 01 武田为癌症资产预付信达生物12亿美元，潜在里程碑付款总额超百亿美元在涉及中国生物科技公司的数十亿美元许可交易频发之年，武田与信达的合作脱颖而出。这家日本制药巨头为获得中国药物开发商的两款癌症资产，同意预付12亿美元，并提供超过100亿美元的潜在里程碑付款。对武田而言，此次交易旨在为未来十年寻找增长源，以应对炎症性肠病药物 Entyvio 逐渐临近的专利悬崖。 02 Nkarta 首席执行官 Hastings 警告勿对中国生物技术施加制裁在本月早期的"亚洲生物科技周"活动上，Nkarta 公司首席执行官 Paul Hastings 呼吁美国联邦政府不要限制行业从中国引进候选药物的授权合作。这位生物科技公司高管解释道："我们能使用TikTok"，那为何不能合作研发药物？"此番言论发表之际，地缘政治局势紧张，但中国的许可交易是美国生物制药行业创新的关键来源。 03 授权交易热潮：罗氏与翰森制药就抗体偶联药物达成合作，Rani与中外制药签订协议上周末，多家亚洲生物制药公司签署了高额授权协议。其中，罗氏同意支付高达14.5亿美元，以获得翰森制药一款实验性抗 CDH17 抗体偶联药物（ADC）HS-20110 在中国大陆以外地区的研发、生产和销售授权。此外，Rani Therapeutics 还与罗氏子公司——日本中外制药（Chugai）达成一项口服给药技术合作协议，其价值可能超过10亿美元。 04 默克对'主力产品' TROP2 ADC 信心倍增，合作伙伴科伦博泰公布三期试验胜利上周末举办的欧洲肿瘤内科学会（ESMO）大会上，包括默克（Merck）抗体偶联药物（ADC）合作伙伴科伦博泰生物（Kelun-Biotech）在内的多家亚洲生物制药企业公布了试验数据。根据大会公布的数据，由科伦博泰研发、默克获得授权的抗体偶联药物芦康沙妥珠单抗（sacituzumab tirumotecan, sac-TMT），在肺癌和乳腺癌的两项独立研究中表现出色。默克公司高级副总裁、肿瘤全球临床开发负责人Marjorie Green 医学博士表示，这些结果让默克对该候选药物更有信心。 05 第一三共与默克合作的卵巢癌抗体偶联药物II期试验达标，即将推进关键III期试验同样在欧洲肿瘤内科学会（ESMO）大会上，默克（Merck）与其合作伙伴第一三共（Daiichi Sankyo）公布了抗 CDH6 抗体偶联药物 raludotatug deruxtecan（R-DXd）的最新数据。在一项针对对铂类化疗耐药的复发性卵巢癌、原发性腹膜癌或输卵管癌患者的二期临床试验中，研究人员记录到该药物的总缓解率（ORR）达到50.5%。目前，双方合作伙伴正准备推进该药物的 III 期临床试验。 06 阿斯利康、第一三共释放 Enhertu 双重威力，旨在重塑早期乳腺癌格局第一三共（Daiichi Sankyo）在欧洲肿瘤内科学会（ESMO）大会上的亮相不仅限于公布 R-DXd 的数据。事实上，这家日本公司与阿斯利康在抗体偶联药物（ADC）领域的合作还取得了另外两项令人瞩目的成果。目前，双方正与吉利德科学（Gilead Sciences）在 TROP2 抗体偶联药物（ADC）领域展开竞争，新一轮试验数据显示注射用德达博妥单抗（Datroway）更具优势。而对于上市时间更早的注射用德曲妥珠单抗（Enhertu），其在早期乳腺癌领域的两项试验数据不仅为改善患者治疗带来了潜在机遇，同时也引发了一个新的问题。原文链接： https://www.fiercepharma.com/pharma/fierce-pharma-asia-licensing-deal-flow-china-crackdown-warning-and-esmo-readouts -End- 点赞在看转发留言欢迎您与我们互动

抗体药物偶联物引进/卖出临床2期临床3期临床成功

2025-10-24

·FiercePharma

Fierce Pharma Asia—Licensing deal flow, China crackdown warning and ESMO readouts

A group of licensing agreements, a CEO's warning about overenforcement of China dealmaking and multiple ESMO readouts made our news this week. Among a string of licensing deals from last week, Takeda's tie-up with Innovent stole the show. Nkarta CEO Paul Hastings recently spoke to the importance of the industry's collaborations with Chinese biopharma companies. Asian biopharmas had a large presence at a major cancer conference over the weekend. Plus more.1. Takeda pays Innovent $1.2B upfront, offers whopping $10B-plus in biobucks for cancer assets In a year full of billion-dollar licensing deals involving Chinese biotechs, Takeda’s tie-up with Innovent stands out. The Japanese pharma giant agreed to put down $1.2 billion upfront and offered up more than $10 billion in potential milestones to get its hands on a pair of cancer assets from the Chinese drug developer. For Takeda, the deal represents an effort to identify sources of growth for the next decade as inflammatory bowel disease medicine Entyvio creeps toward its patent cliff. 2. ‘We can have TikTok. Why can’t we have drugs?’: Nkarta CEO Hastings warns against China biotech penalties At Fierce Biotech Week earlier this month, Nkarta CEO Paul Hastings urged the federal government to not crack down on the industry’s licensing of drug candidates from China. “We can have TikTok,” the biotech CEO explained, so “why can’t we have drugs?” The comments come at a time of geopolitical tensions, but China's licensing deals represent a critical source of innovation for the U.S. biopharma industry. 3. Licensing galore: Roche ties up with Hansoh on ADCs as Rani rounds out week with Chugai pact 4. Kite puts $1.6B on the line to pair up with China’s Pregene for another in vivo CAR-T deal Toward the end of last week, several Asian biopharma companies inked high-dollar licensing deals. In one deal, Roche agreed to pay up to $1.45 billion in exchange for an ex-China license to develop, manufacture and sell Hansoh's experimental CDH17-targeted antibody-drug conjugate (ADC) dubbed HS-20110. In addition to that deal, Rani Therapeutics linked up with Japan’s Chugai, a Roche subsidiary, in an oral delivery technology pact that could climb to more than $1 billion in value. Rounding out the action, Gilead’s Kite Pharma showcased its interest in in vivo CAR-T tech by striking an agreement with China’s Pregene. 5. Merck grows more ambitious about 'workhorse' TROP2 ADC as partner Kelun posts phase 3 wins The European Society for Medical Oncology (ESMO) congress over the weekend featured data presentations from numerous Asian biopharmas, including Merck’s ADC partner Kelun-Biotech. Sacituzumab tirumotecan (sac-TMT), developed by China’s Kelun and licensed by Merck, excelled in separate studies in lung cancer and breast cancer, according to data presented at ESMO. The results contribute to Merck’s optimism about the candidate, Marjorie Green, M.D., Merck’s senior vice president and head of oncology global clinical development, told Fierce. 6. ESMO: Daiichi, Merck power ovarian cancer ADC toward pivotal test after passing phase 2 Also at ESMO, Merck and partner Daiichi Sankyo released new data for their CDH6-directed ADC raludotatug deruxtecan (R-DXd). In a phase 2 study assessing the candidate in patients with recurrent ovarian, primary peritoneal or fallopian tube cancer that was resistant to platinum chemotherapy, investigators recorded an overall response rate of 50.5%. The partners are now readying a push into phase 3. 7. ESMO: AZ, Daiichi’s Datroway outshines Gilead’s Trodelvy in first global TROP2 showdown 8. ESMO: AZ, Daiichi unleash Enhertu's 2-fisted power, aiming to reshape early breast cancer landscape Daiichi Sanyko’s presence at ESMO wasn’t limited to the R-DXd presentation. In fact, the Japanese company’s ADC alliance with AstraZeneca yielded two more impressive showings. As the partners duel with Gilead Sciences in the TROP2 ADC field, a new round of readouts points to an advantage for Datroway. And for the older Enhertu, a pair of trial readouts in early breast cancer open the door to a potential opportunity to advance patient care—while raising a new question. 9. China pricing pressure continues to weigh on Roche's diagnostics business Even as Roche contends with pricing pressures in China, the company’s diagnostics division was able to eke out 1% sales growth during the first 9 months of 2025. Overall, Roche’s diagnostic sales in the Asia-Pacific region were down 15% during the period, while sales in all other geographic regions were up. Year-to-date, Roche’s China diagnostic sales fell 27%, Matt Sause, CEO of Roche Diagnostics, said on Thursday. 10. ESMO: Akeso, Summit's ivonescimab beats PD-1 in first chemo combo win in 1st-line NSCLC As China’s Akeso and its U.S. partner Summit Therapeutics continue to break new ground with their PD-1xVEGF bispecific ivonescimab, the drug delivered another first at ESMO. Data revealed at the conference show that the therapy can delay tumor progression versus a PD-1 inhibitor as part of a combination with chemotherapy. The results come from a study limited to China.Other News of Note: 11. Lilly, Cipla link up in India tirzepatide distribution pact (release) 12. Japan VC firm Fast Track Initiative raises roughly $130M (release) 13. ESMO: GSK says 'stay tuned' for more ADC data after partner Hansoh posts 49% response rate 14. Regeneron settles Eylea patent dispute with Celltrion, allowing another biosimilar to launch at end of 2026 15. Astellas walks away from gene therapy pact with Taysha before pivotal trial launch

引进/卖出临床2期临床3期临床结果抗体药物偶联物

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
输卵管癌	临床3期	美国	Daiichi Sankyo Propharma Co., Ltd.	2024-02-27
输卵管癌	临床3期	美国	第一三共（中国）投资有限公司	2024-02-27
输卵管癌	临床3期	美国	Daiichi Sankyo, Inc.	2024-02-27
输卵管癌	临床3期	日本	Daiichi Sankyo, Inc.	2024-02-27
输卵管癌	临床3期	日本	第一三共（中国）投资有限公司	2024-02-27
输卵管癌	临床3期	日本	Daiichi Sankyo Propharma Co., Ltd.	2024-02-27
输卵管癌	临床3期	澳大利亚	Daiichi Sankyo Propharma Co., Ltd.	2024-02-27
输卵管癌	临床3期	澳大利亚	Daiichi Sankyo, Inc.	2024-02-27
输卵管癌	临床3期	澳大利亚	第一三共（中国）投资有限公司	2024-02-27
输卵管癌	临床3期	巴西	第一三共（中国）投资有限公司	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, ESMO2025) 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)	構遞醖願顧窪製餘鹹齋(鹽製蓋選遞願鑰餘選築) = 衊築選積壓齋夢艱廠積範襯顧衊夢餘範簾願鑰 (鑰顧鹹顧觸選齋獵餘齋, 27.9 ~ 61.9) 更多	积极	2025-10-17
NCT06161025 (REJOICE-Ovarian01, ESMO2025) 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 (5.6 mg/kg)	構遞醖願顧窪製餘鹹齋(鹽製蓋選遞願鑰餘選築) = 鹽憲獵夢製醖衊鹽簾糧範襯顧衊夢餘範簾願鑰 (鑰顧鹹顧觸選齋獵餘齋, 32.9 ~ 67.1) 更多	积极	2025-10-17
NCT04707248 (Corporate Publications) 人工标引	临床1期	卵巢癌	50	Raludotatug deruxtecan	構鏇鏇積餘窪鑰艱簾網(膚網齋鹹鹹簾繭淵衊膚) = 淵餘淵醖鬱衊製築範醖顧鏇餘糧夢遞鬱簾艱鬱 (憲憲獵襯顧襯憲鹽壓廠, 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	觸窪選繭壓糧積鏇艱構(醖築壓網觸選廠遞簾獵) = 窪觸築遞選網醖簾壓糧鑰糧繭簾衊憲糧鹹遞襯 (糧壓選醖選鑰範獵衊夢 ) 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 6.4 mg/kg	觸窪選繭壓糧積鏇艱構(醖築壓網觸選廠遞簾獵) = 觸網餘餘簾獵憲願壓膚鑰糧繭簾衊憲糧鹹遞襯 (糧壓選醖選鑰範獵衊夢 ) 更多	积极	2023-10-22
NCT04707248 (ASCO2022) 人工标引	临床1期	卵巢癌 \| 晚期肾细胞癌	22	DS-6000a	觸範夢範廠齋蓋鏇範願(築齋構壓蓋遞選製夢願) = 齋糧繭憲衊齋醖製壓鏇憲構糧鏇網艱醖餘築膚 (觸獵餘選衊鹹齋願簾觸 ) 更多	积极	2022-06-02