德达博妥单抗(Datopotamab Deruxtecan) - 药物靶点：Top I x Trop-2_在研适应症：EGFR阳性非小细胞肺癌，ER阳性/HER2阴性乳腺癌，晚期非小细胞肺癌_专利_临床

概要

基本信息

药物类型

ADC

别名

Dato-DXd、Datopotamab Deruxtecan-dlnk、达妥维妥单抗

+ [9]

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

肿瘤呼吸系统疾病皮肤和肌肉骨骼疾病+ [4]

在研适应症

EGFR阳性非小细胞肺癌ER阳性/HER2阴性乳腺癌晚期非小细胞肺癌+ [43]

非在研适应症

非小细胞肺癌 III期鳞状非小细胞肺癌

原研机构

Daiichi Sankyo Co., Ltd.

在研机构

AstraZeneca Canada, Inc.

阿斯利康投资（中国）有限公司

AstraZeneca PLC

+ [12]

非在研机构-

权益机构

AstraZeneca PLC

Daiichi Sankyo Co., Ltd.Gustave Roussy, Cancer Campus, Grand Paris

最高研发阶段批准上市

首次获批日期

日本 (2024-12-27),

HR阳性/HER2阴性乳腺癌

最高研发阶段(中国)批准上市

特殊审评加速批准 (美国)、优先审评 (美国)、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 524309355L

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Sequence Code 524309356H

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关联

47

项与德达博妥单抗相关的临床试验

NCT07357597

/ Not yet recruiting临床4期

A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH)

This is a multicenter, open-label, single-arm study of prophylaxis for Dato-DXd-related stomatitis in eligible patients with metastatic or inoperable locally recurrent breast cancer or locally advanced or metastatic Epidermal Growth Factor Receptor-Mutated (EGFRm) non-small cell lung cancer.

开始日期2026-02-27

申办/合作机构

AstraZeneca PLC

[+1]

NCT07069595

/ Not yet recruiting临床2期

PREDICT-RD: Postoperative Molecular Residual Disease by ctDNA Surveillance in TNBC With Residual Disease

This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II/III triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II/III after conventional neoadjuvant chemo-immunotherapy followed by surgery. Technological advances in ctDNA assays have improved both the sensitivity and reliability of molecular residual disease (MRD) detection to enable real-time measurement with clinical-grade assays.
The primary objective of this study will be to evaluate ctDNA-based MRD status in high-risk, early-stage TNBC patients by defining the proportion of TNBC patients with MRD-only recurrence (ctDNA positive without radiographically measurable recurrence) during post-surgery surveillance. The secondary objectives will evaluate the safety, preliminary efficacy, and survival outcomes of using Dato-DXd in participants with MRD-only TNBC.
Dato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) that has demonstrated promising efficacy in TNBC patients with a manageable safety profile.

开始日期2026-01-01

申办/合作机构

Lineberger Comprehensive Cancer Center

[+1]

NCT07291037

/ Recruiting临床3期

A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)

TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).

开始日期2025-10-31

申办/合作机构

AstraZeneca PLC

[+1]

100 项与德达博妥单抗相关的临床结果

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100 项与德达博妥单抗相关的转化医学

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100 项与德达博妥单抗相关的专利（医药）

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99

项与德达博妥单抗相关的文献（医药）

2026-02-01·CANCER TREATMENT REVIEWS

Intracranial activity of antibody-drug conjugates in advanced non-small cell lung cancer: What have we accomplished so far?

Review

作者: Remon, Jordi ; Hendriks, Lizza E L ; Huang, Derek De-Rui ; Cheo, Seng Wee ; Voon, Pei Jye ; Saw, Stephanie P L ; Addeo, Alfredo ; Li, Molly S C ; Menis, Jessica

Antibody-drug conjugates (ADCs) represent a rapidly evolving class of therapeutics in non-small cell lung cancer (NSCLC), offering targeted delivery of cytotoxic payloads to tumor cells while minimizing off-target toxicity. Although ADCs have demonstrated promising results in NSCLC, their efficacy in treating central nervous system (CNS) metastases has been uncertain due to concerns over blood-brain barrier (BBB) penetration and the lack of dedicated CNS-specific evaluations in clinical trials. However, emerging evidence challenges this paradigm. While earlier-generation ADCs such as T-DM1 exhibited limited CNS efficacy, newer ADCs employing optimized linkers and cytotoxins demonstrate more favorable efficacy and toxicity profiles. Selected agents, including trastuzumab deruxtecan, datopotamab deruxtecan and patritumab deruxtecan, have all shown intracranial responses in patients with advanced NSCLC with brain metastases (BM). Proposed mechanisms facilitating CNS activity include BBB disruption by BM, membrane-permeable and highly potent cytotoxic payloads, and bystander effects that enable tumor cell killing beyond the target antigen. Nevertheless, several limitations remain, including variability in trial designs, limited number of patients with untreated CNS disease, and a lack of CNS-specific endpoints. Given the high incidence of BM in NSCLC and their significant impact on patient outcomes, there is an urgent need to better understand the intracranial activity of ADCs and whether they can prevent the development of CNS metastases, especially as some of these ADCS are being tested in the curative-intent setting. This review synthesizes current evidence and highlights ongoing trials, with a focused examination of the evolving role of ADCs in the management of BM.

2026-02-01·CANCER TREATMENT REVIEWS

Clinical overview of trophoblast surface antigen 2 antibody-drug conjugates in non–small cell lung cancer

Review

作者: Naidoo, Jarushka ; Gadgeel, Shirish ; Mino-Kenudson, Mari ; Sethakorn, Nan ; Patel, Sandip Pravin

Lung cancer remains the leading cause of cancer-related death in the United States, with non-small cell lung cancer (NSCLC) accounting for most lung cancer cases. Improvements in first-line treatment with immuno-oncology and targeted therapies have been observed in patients with NSCLC, but benefits may be limited for those with advanced or metastatic NSCLC (mNSCLC). Following progression on frontline therapies, later-line therapies offer modest benefits and are associated with pronounced adverse effects. Accordingly, there is a need for new, more effective options to improve survival and quality of life. Trophoblast surface antigen 2 (TROP2) antibody-drug conjugates (ADCs) are a novel approach to address unmet treatment needs in NSCLC. There are 5 TROP2-directed ADCs currently under investigation for treatment of NSCLC: datopotamab deruxtecan, sacituzumab govitecan, sacituzumab tirumotecan, DB-1305, and SHR-A1921. Here, we provide an overview of the properties of each ADC as well as efficacy and safety data from clinical trials of patients with NSCLC with or without actionable genomic alterations (AGAs). The unique characteristics of each ADC and its components, particularly the linker chemistry and payload attributes, define the mechanism of action and subsequently influence dosing, efficacy, and safety. TROP2 ADCs have shown antitumor responses with a manageable safety profile in patients with mNSCLC in several ongoing and completed trials. Additional studies are required to understand how these agents can be effectively integrated into the treatment paradigm for lung cancer, taking into consideration sequential use of multiple ADCs, resistance mechanisms, combination therapies, and use in special populations.

2026-02-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

TROP-2–directed antibody–drug conjugates in advanced NSCLC: A systematic review and meta-analysis of efficacy, safety, and reconstructed survival outcomes

Review

作者: Siddiqui, Hafiza Tooba ; Rath, Shree ; Alam, Umama ; Ansab, Muhammad ; Desai, Aakash ; Burhan, Muhammad

INTRODUCTION:

Non-small cell lung cancer (NSCLC) represents the majority of lung cancer cases worldwide, with most patients diagnosed at advanced stages and limited by resistance to existing therapies. TROP-2, an epithelial cell surface glycoprotein overexpressed in many NSCLCs, has emerged as a promising therapeutic target for antibody-drug conjugates (ADCs). This study aims to systematically evaluate the efficacy and safety of TROP-2-directed ADCs in patients with advanced or metastatic NSCLC.

METHODS:

Electronic databases (PubMed, Embase, Clinical Trials and Cochrane Central) were searched up to November 2025 for studies reporting outcomes in advanced NSCLC patients treated with TROP-2-directed ADCs. Eligible studies included adult populations with advanced NSCLC that were treated with datopotamab deruxtecan, sacituzumab govitecan, or sacituzumab tirumotecan, and reported efficacy or safety outcomes. Pseudo-individual patient-level data for survival analyses were reconstructed from published Kaplan-Meier curves. Pooled effect sizes were estimated using random-effects meta-analytic models.

RESULTS:

Seven studies encompassing 1365 patients with advanced or metastatic NSCLC were included. The pooled median overall survival (OS) was 16.38 months (95 % CI: 11.17-22.96), and the median progression-free survival (PFS) was 6.08 months (95 % CI: 4.93-8.55). The objective response rate (ORR) across studies was 29 % (95 % CI: 19 %-39 %), with a disease control rate (DCR) of 79 % (95 % CI: 74 %-84 %). Subgroup analysis revealed patients with EGFR-mutated tumors had a significantly higher likelihood of response (risk ratio 1.70, 95 % CI: 1.11-2.61). Safety analysis showed treatment-emergent adverse events (TEAEs) in 98 % (95 % CI: 94 %-100 %), grade ≥ 3 TEAEs in 52 % (95 % CI: 38 %-67 %), and interstitial lung disease (ILD) in 9 % (95 % CI: 3 %-16 %).

CONCLUSION:

TROP-2-directed ADCs demonstrate meaningful efficacy in previously treated advanced NSCLC, especially among EGFR-mutant and non-squamous histology patients, with survival and response outcomes superior to traditional chemotherapy. However, high rates of adverse events, particularly ILD, necessitate close monitoring. Further randomized and biomarker-driven studies are warranted to refine patient selection and optimize the therapeutic potential of these agents.

1,507

项与德达博妥单抗相关的新闻（医药）

2026-02-04

·小白学药

ADC赛道变局! 巨头终止下一代药物, AOC携 PNA技术杀入ADC下一代精准治疗2.0

点击关注小白学药 ADC 赛道迎变局：巨头终止下一代药物，这家公司用 AOC 开辟新战场 2026 年初，抗体偶联药物（ADC）领域迎来了 “冰与火” 交织的消息：一边是巨头 Daiichi Sankyo 突然终止下一代 ADC 药物 DS-9606 的开发，引发行业对赛道前景的讨论；另一边是韩国 HLB Panagene 宣布进军 AOC 疗法，以突破性技术向 ADC 的 “下一代” 发起冲击。 ADC 行业早已进入深度竞争与技术迭代的关键期。巨头的 “战略取舍”：ADC 研发没有 “坦途” 2 月 3 日，日本制药巨头 Daiichi Sankyo 宣布终止下一代抗癌 ADC 药物 DS-9606 的内部开发，这一决定来自公司的战略组合审查。作为首款计划采用修饰型吡咯并苯并二氮杂䓬（mPBD） payload 的 ADC，DS-9606 曾被寄予厚望，且已在生殖细胞肿瘤中验证了效用，但最终因 “portfolio 布局考量” 止步。这并非 Daiichi 在 ADC 领域的首次挫折。其另一款核心 ADC 药物 Datroway 近年来波折不断：2024 年 5 月晚期非小细胞肺癌（NSCLC）III 期试验失败，9 月乳腺癌 III 期研究再遇阻，原本预计 2025 下半年公布的联合疗法 III 期数据，如今也推迟至 2026 年下半年。尽管 Datroway 已获批用于部分乳腺癌和经治 EGFR 突变 NSCLC，但频繁的研发波折，折射出 ADC 药物从实验室到临床的艰难。欢迎关注小白学药视频号值得注意的是，Daiichi 并未放弃 mPBD 平台 —— 公司明确表示，该平台的有效性已得到确认，后续将继续探索其他靶点和载体抗体。这种 “弃药物、保平台” 的战略，也反映出 ADC 研发的核心逻辑：单一药物的成败不代表技术路线的终结，精准的靶点选择与平台优化才是长久之道。ADC 的 “核心密码”：抗体才是决定成败的关键为何 ADC 研发如此 “坎坷”？欧洲生物技术杂志的最新研究给出了答案：ADC 的成功，关键不在于毒素 payload 或连接子（linker），而在于抗体本身。作为 ADC 的 “导航系统”，抗体直接决定了药物的靶向精度、治疗窗口和安全性。传统 ADC 常面临 “脏靶点” 难题 —— 肿瘤抗原与健康组织抗原交叉表达，容易导致脱靶毒性；而抗原密度、内化效率等变量，更让抗体优化成为 “精细活”。临床数据显示，未充分优化的抗体，即便搭配强效 payload 和稳定连接子，也可能导致疗效不佳或毒性超标。如今，抗体工程技术正在破解这些难题：双特异性抗体、双表位抗体能强化肿瘤选择性，pH 敏感型、蛋白酶可切割型等条件激活设计能减少全身暴露；更前沿的 TCR 模拟抗体（TCRm），还能突破细胞膜限制，靶向细胞内抗原，拓宽 ADC 的靶点边界。从 “单纯载体” 到 “工程化核心”，抗体技术的升级，正在推动 ADC 从 “广谱精准” 走向 “超精准”。下一代疗法登场：AOC 能否超越 ADC？就在 ADC 巨头调整步伐之际，HLB Panagene 推出抗体 - 寡核苷酸偶联物（AOC），为精准治疗开辟了新方向(继ADC之后，下一个千亿赛道？AOC技术全景解析)。 AOC 延续了 ADC “抗体 - 连接子 - payload” 的核心结构，但做出了关键革新：将 payload 从细胞毒性药物，替换为能直接调控基因表达的核酸疗法。这一改变让疗法的适用范围从癌症拓展到遗传疾病，同时减少了细胞毒性带来的副作用，堪称 “精准治疗 2.0”。不过，核酸 payload 面临天然短板：细胞穿透性差、易被酶降解、易困在内涵体中难以起效。 HLB Panagene 给出的解决方案是 —— 采用肽核酸（PNA）作为 payload 核心。 PNA 结构稳定，能抵抗核酸酶降解，且靶向结合精度极高，即便通过抗体递送进入细胞，也能精准抵达目标位点，完美解决了传统核酸疗法的 “递送难题”。目前，HLB Panagene 已将杜氏肌营养不良症（DMD）作为首个研发方向。这种由基因缺陷导致的疾病，恰好契合 AOC“基因调控 + 精准递送” 的优势。借助 PNA 技术的积累，公司正从精准诊断领域向疗法领域延伸，试图打造下一代精准治疗的 “标杆产品”。赛道迭代启示：精准治疗的未来，在于 “持续进化” 从 ADC 的 “取舍” 到 AOC 的 “破局”，不难看出精准治疗领域的核心趋势：没有永远的 “明星疗法”，只有不断迭代的技术创新。 ADC 赛道虽面临研发挑战，但抗体工程的突破正在持续拓宽其边界；而 AOC 等下一代技术，通过替换核心组件、解决底层痛点，正在开辟新的治疗场景。对于药企而言，既要像 Daiichi 那样保持战略灵活性，不被单一药物的成败束缚；也要像 HLB Panagene 那样，深耕核心技术，找到差异化突破口。未来，精准治疗的竞争将不再是 “谁的 payload 更强”，而是 “谁的递送更准、谁的技术更稳、谁的场景更广”。 ADC 与 AOC 的同台竞技，最终受益的将是更多患者 —— 毕竟，医学进步的本质，就是在不断试错与创新中，为生命寻找更多可能。你觉得 AOC 会成为下一个 ADC 级别的 “风口疗法” 吗？欢迎在评论区留下你的观点～点击关注小白学药喜欢就点个感恩一路相伴推荐阅读破解耐药+全球突围! 信达三抗获FDA快车道, 亚洲43%创新管线领跑世界艾伯维ADC落地韩国改写卵巢癌治疗; 弼领生物 2 亿 B 轮加码纳米偶联下一代抗体药物浪潮来袭：ADC、双抗领衔，研发、生产、商业化全解析2026上半年10大核心临床trial干货：巨头卡位、Biotech翻身战全解析GSK联手韩国公司, 改写PD-1给药规则; 2026 Biotech复苏藏三大隐忧！艾伯维双抗命悬一线, 但故事没完! ADC赛道再添狠角色! 乐天生物, 2026 新基地剑指全球JPM26落幕，2026医药行业格局已定？并购回暖、巨头冲刺、赛道内卷, 谁将笑到最后？医药人必藏双平台:「小白学药」公众号+视频号2026 年全球生物制药领域核心会议指南：见证医学突破与行业风向HER2 阳性膀胱癌患者福音！RC48-ADC 免疫联合疗法，疗效提升 6.75 倍，安全性可控百亿布局! Ipsen联手先声药业押注ADC新赛道, 靶向LRRC15资产引关注2025创新药年终考: 融资超40亿美元, BD破千亿美金, ADC/双抗扛起大旗！不止双特异性抗体！新型表达载体技术，多链生物疗法加速落地从 License-out 到联合研发，抗体与 ADC 引领创新，全球药企竞逐大分子赛道1 月医药圈炸场：荣昌生物 56 亿 BD 交易、科伦 ADC 获突破性疗法，中国创新药的 “出海 + 内卷” 双节奏继ADC之后，下一个千亿赛道？AOC技术全景解析声明：本公众号所有推文不构成任何投资意见和建议，科普性质内容，非医疗建议。转载请注明出处：小白学药公众号。部分内容源于网络公开信息，仅用于交流学习传播知识，侵删。因水平有限，若出现错误，欢迎指出。 #ADC #AOC #偶联药物

抗体药物偶联物临床3期引进/卖出

2026-02-04

·搜狐新闻

ADC药物德达博妥单抗（Dato-DXd）治疗三阴性乳腺癌的临床数据

2026年2月3日，第一三共和阿斯利康共同宣布，其联合开发的TROP-2靶向ADC药物Dato-DXd（商品名：Datroway/达卓优，通用名：Datopotamab deruxtecan/德达博妥单抗，代号：DS-1062a）的补充生物制剂许可申请（sBLA）已获美国FDA受理，并被授予优先审评资格，用于一线治疗无法切除或转移性三阴性乳腺癌（TNBC）成人患者，这些患者不适合接受PD-1/PD-L1抑制剂治疗。此前，该sBLA已在2025年12月获得中国国家药品监督管理局（NMPA）受理。TROP-2（滋养层细胞表面抗原2）是一种跨膜糖蛋白，在多种肿瘤中表达水平会显著升高，包括乳腺癌、肺癌、胃癌、结肠直肠癌、胰腺癌、前列腺癌、宫颈癌、头颈癌和卵巢癌等。其高度表达在肿瘤生长过程中起关键作用，还与更具侵袭性的疾病和预后不良相关，其高表达和表达差异化的特点是很好的ADC药物靶点选择。Dato-DXd是一种靶向TROP-2的ADC药物，由人源化抗TROP2 IgG1单克隆抗体与有效载荷强效拓扑异构酶I抑制剂通过稳定的四肽可裂解连接子偶联而成。值得一提的是，Dato-DXd分别于2025年1和8月在美国和中国批准上市，用于治疗无法切除或转移性激素受体（HR）阳性、HER2阴性的成年乳腺癌患者，这些患者曾接受过内分泌疗法和化疗。商品名：Datroway（达卓优）通用名：Datopotamab deruxtecan（德达博妥单抗）代号：DS-1062a靶点：TROP2厂家：第一三共（Daiichi Sankyo）、阿斯利康（AstraZeneca）规格：100mg/每瓶美国首次获批：2025年1月中国首次获批：2025年8月日本首次获批：2024年12月获批适应症：HR阳性/HER2阴性乳腺癌、EGFR突变肺癌推荐剂量：6mg/kg，每3周静脉输注一次，21天作为一个治疗周期。储存条件：2-8°C冷藏临床数据该补充生物制剂许可申请是基于III期TROPION-Breast02临床试验的研究结果。该数据已在2025年欧洲肿瘤内科学会（ESMO）大会上公布。研究结果显示，与化疗作为一线治疗相比，Dato-DXd在该患者群体中实现了具有统计学意义且临床意义明确的总生存期改善，中位总生存期延长5.0个月，并将疾病进展或死亡风险降低43%。Dato-DXd组的中位总生存期（OS）为23.7个月，而化疗组为18.7个月。两组的中位无进展生存期（PFS）分别为10.8个月和5.6个月。此外，Dato-DXd还带来了更强且更持久的治疗缓解，其客观缓解率（ORR）为62.5%，中位缓解持续时间（DOR）为12.3个月；而化疗组的ORR为29.3%，中位DOR为7.1个月。在安全性方面，Dato-DXd在TROPION-Breast02研究中的安全性与先前Dato-DXd针对乳腺癌的临床试验结果一致。Dato-DXd组报告的最常见任何级别治疗相关不良事件（TRAEs）为干眼症、口腔炎、恶心、便秘、呕吐和食欲下降等。小结对于不适合免疫治疗的转移性三阴性乳腺癌患者，Dato-DXd可能成为首个在一线治疗中获批的药物。与化疗相比，Dato-DXd可显著延长总生存期，并将无疾病进展或死亡的生存时间延长近一倍。期待未来有望为这类转移性三阴性乳腺癌患者提供一种新治疗选择。【重要提示】印塔健康旗下公众号【全球好药资讯】所有文章信息仅供参考，具体治疗谨遵医嘱！返回搜狐，查看更多

优先审批上市批准临床3期抗体药物偶联物申请上市

2026-02-04

·Business Wire

DS3790 Enters Clinical Development as First DXd ADC in Hematology from Industry-Leading ADC Portfolio of Daiichi Sankyo

TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--The first patient has been dosed in a first-in-human phase 1/2 trial evaluating DS3790 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. DS3790 is a specifically engineered, potential first-in-class CD37 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568). CD37 is a transmembrane protein that plays a role in regulating cell survival and is overexpressed on malignant B-cells, making it a promising therapeutic target.1 Currently, there are no CD37 directed therapies approved for any type of cancer. “The initiation of this trial of DS3790 with its novel CD37 target marks a significant milestone as our first DXd antibody drug conjugate in hematology,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “DS3790 expands our portfolio to seven DXd antibody drug conjugates, all developed using our in-house technology, underscoring our dedication to scientific innovation to create new medicines for patients with cancer.” About the Phase 1/2 Trial The multicenter, open-label, multi-cohort, first-in-human phase 1/2 trial will assess the safety and efficacy of DS3790 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The first part of the trial (dose escalation) is evaluating DS3790 as a monotherapy to determine the recommended dose for expansion. The second part of the trial (dose expansion) will consist of multiple expansion cohorts to further evaluate DS3790 as a monotherapy. Following the assessment of preliminary safety and efficacy in the monotherapy part of the trial, subsequent cohorts will evaluate DS3790 in combination with other targeted therapies in both dose escalation and dose expansion phases. The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events, as well as efficacy endpoints including overall response, disease control rate, duration of response, time to response, progression-free survival and overall survival. Pharmacokinetics and biomarker endpoints also will be assessed. The trial is expected to enroll approximately 420 patients across multiple sites globally, including Asia, Europe and North America. For more information, please visit ClinicalTrials.gov. About CD37 CD37 is a transmembrane protein that plays a role in regulating cell survival and is overexpressed in various B-cell hematological malignancies.1 B-cells, which are a type of white blood cell (B-lymphocyte) that help the body fight infection, can uncontrollably multiply and fail to function properly.2 Because of its high prevalence on B-cells, CD37 is considered a promising therapeutic target for the treatment of B-cell cancers.3 Currently, there are no CD37 directed therapies approved for any type of cancer. About B-cell Non-Hodgkin Lymphoma More than 604,000 cases of non-Hodgkin lymphoma were diagnosed in 2021, with approximately 267,000 deaths globally.4 B-cell non-Hodgkin lymphoma accounts for more than 85% of all non-Hodgkin lymphoma cases with a five-year survival rate of 74%.5 While advances in targeted therapies have improved outcomes in B-cell non-Hodgkin lymphoma, many patients with relapsed or refractory disease continue to face limited treatment durability and poor long-term survival.6 About DS3790 DS3790 is an investigational, potential first-in-class CD37 directed ADC. Designed using the proprietary DXd ADC technology of Daiichi Sankyo, DS3790 is comprised of a humanized anti-CD37 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. 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 is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com. References: Moore K, et al. J Pathol . 1987; 152 (1): 13-21. Mayo Clinic. Diffuse large B-cell lymphoma . Accessed November 2025. Payandeh Z, et al. Biotechnol Lett . 2018; 40 (11-12): 1459-66. Li T, et al. Ann Hematol . 2025; doi:10.1007/s00277-025-06559-9. Cleveland Clinic. Non-Hodgkin Lymphoma . Accessed November 2025. Ayyappan A, et al. J Hematol Oncol . 2019; 12 (82): 1.

抗体药物偶联物

100 项与德达博妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16410

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阳性非小细胞肺癌	美国	Daiichi Sankyo, Inc.	2025-06-23
ER阳性/HER2阴性乳腺癌	澳大利亚	AstraZeneca Pty Ltd.	2025-05-20
晚期非小细胞肺癌	加拿大	AstraZeneca Canada, Inc.	2025-03-01
HR阳性/HER2阴性乳腺癌	日本	Daiichi Sankyo Co., Ltd.	2024-12-27

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
三阴性乳腺癌	申请上市	中国	Baxter Oncology GmbH	2025-12-22
三阴性乳腺癌	申请上市	中国	Daiichi Sankyo Europe GmbH	2025-12-22
EGFR突变的非小细胞肺癌	申请上市	美国	Daiichi Sankyo Co., Ltd.	2024-11-12
EGFR突变的非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-11-12
局部晚期非鳞状非小细胞肺癌	申请上市	美国	Daiichi Sankyo, Inc.	2024-02-19
局部晚期非鳞状非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-02-19
转移性非鳞状非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-02-19
转移性非鳞状非小细胞肺癌	申请上市	美国	Daiichi Sankyo, Inc.	2024-02-19
膀胱癌	临床3期	美国	Daiichi Sankyo Co., Ltd.	2025-09-26
膀胱癌	临床3期	中国	Daiichi Sankyo Co., Ltd.	2025-09-26

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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


NCT05104866 (TROPION-Breast01, CTgov)	临床3期	转移性HER2阴性乳腺癌	732	Dato-DXd	範選襯鹽鏇壓顧製範壓(遞築餘蓋鬱鹹窪顧構範) = 齋範夢網夢糧餘願艱膚糧鏇鬱範鏇製鬱簾廠積 (艱網艱選壓夢鏇製壓蓋, 獵簾鹽衊襯範夢鑰艱窪 ~ 蓋顧構糧夢窪顧淵衊鏇) 更多	-	2026-02-04
NCT06176261 (DATO-BASE, SABCS 12025 \| SABCS 22025)	临床2期	HER2 阴性乳腺癌 \| 脑膜肿瘤 HER2-negative	10	Datopotamab deruxtecan (Dato-DXd) 6 mg/kg IV	製鬱壓淵鑰艱壓獵選繭(壓鏇醖簾齋壓膚範鬱淵) = 襯糧膚淵範觸範簾衊夢顧鏇艱鑰膚夢鹽襯衊顧 (餘選觸膚糧願構範鹹鹹, 0.7 ~ not reached) 更多	积极	2025-12-10
				Datopotamab deruxtecan (Dato-DXd) 6 mg/kg IV (ADC-naïve patients)	製鬱壓淵鑰艱壓獵選繭(壓鏇醖簾齋壓膚範鬱淵) = 鹹鹽衊顧憲艱觸顧窪願顧鏇艱鑰膚夢鹽襯衊顧 (餘選觸膚糧願構範鹹鹹 ) 更多
NCT05374512 (TROPION-Breast02, ESMO2025) 人工标引	临床3期	三阴性乳腺癌一线 HR Negative \| HER2 Negative	644	Dato-DXd (6 mg/kg IV Q3W)	鹽糧蓋繭鹹鏇鏇範蓋構(鬱窪獵齋鏇範蓋糧憲網) = 齋願顧選簾艱膚築淵鹹膚醖齋廠鹹蓋構築蓋鏇 (鹽餘範醖簾窪積構艱獵, 19.8 ~ 25.6) 更多	积极	2025-10-17
				Investigator’s choice of chemotherapy (ICC)	鹽糧蓋繭鹹鏇鏇範蓋構(鬱窪獵齋鏇範蓋糧憲網) = 鹹窪鹹醖醖蓋衊餘鏇築膚醖齋廠鹹蓋構築蓋鏇 (鹽餘範醖簾窪積構艱獵, 16.0 ~ 21.8) 更多
NCT03742102 (BEGONIA, ESMO2025) 人工标引	临床1/2期	三阴性乳腺癌一线 HER2 Negative \| HR Negative	95	Dato-DXd + durvalumab	淵鹹鏇網餘糧選製選遞 \| 選遞艱憲鑰鑰衊夢夢廠(淵觸積醖網憲鏇網醖憲) = 鹽艱膚範築構積構範糧構鹹艱構廠獵衊餘網鏇 (鏇積獵廠衊築積繭憲襯, 10.5 ~ 27.3) 更多	积极	2025-10-17
				Dato-DXd + durvalumabDurvalumab (PD-L1-high)	選遞艱憲鑰鑰衊夢夢廠 \| 襯積鑰襯艱簾齋齋淵製(夢憲艱鏇壓鏇網壓鹹製) = 醖鏇製鏇廠觸網鏇鹹壓簾淵艱齋獵襯顧鑰襯糧 (網鹽範淵顧積觸顧膚餘, 64.5 ~ 93.0) 更多
NCT05489211 (TROPION-PanTumor03, ESMO2025)	临床2期	局部晚期尿路上皮癌二线 \| 一线	40	Dato-DXd + rilvegostomig (1L population)	繭築膚蓋鏇構積鹽鏇壓(夢顧築衊餘製網廠鏇觸) = 夢艱淵淵壓鬱製積憲選憲願簾鏇願選網鹹衊衊 (鑰鹹遞膚淵鑰餘壓構壓 ) 更多	积极	2025-10-17
				Dato-DXd + rilvegostomig (2L population)	繭築膚蓋鏇構積鹽鏇壓(夢顧築衊餘製網廠鏇觸) = 窪鏇醖築糧餘艱憲壓觸憲願簾鏇願選網鹹衊衊 (鑰鹹遞膚淵鑰餘壓構壓 ) 更多
NCT05374512 (TROPION-Breast02, Company_Website) 人工标引	临床3期	转移性三阴性乳腺癌一线 Hormone Receptor Negative \| HER2 Negative	-	Datroway	積構鹹衊壓窪顧淵顧鑰(壓蓋鑰顧鏇淵蓋願簾鬱) = Datroway demonstrated a statistically significant and clinically meaningful improvement for overall survival compared to investigator's choice of chemotherapy. 選鏇餘築壓蓋夢衊願獵 (範獵鹹夢築繭鑰鹽壓餘 ) 更多	积极	2025-10-06
				chemotherapy
NCT04656652 (TROPION-Lung 01 \| TROPION-Lung01, CTgov)	临床3期	转移性非小细胞肺癌	605	DS-1062a (DS-1062a 6.0 mg/kg)	構夢夢齋糧襯衊膚憲醖(製遞築蓋餘構遞衊獵餘) = 範廠網齋積簾鏇餘憲鏇淵網憲範簾餘獵鹹夢鬱 (糧積鹽襯襯蓋醖艱夢憲, 鏇鑰鏇壓獵窪齋醖選鏇 ~ 觸齋構鑰淵齋齋遞餘鏇) 更多	-	2025-07-23
				Docetaxel (Docetaxel 75 mg/m^2)	構夢夢齋糧襯衊膚憲醖(製遞築蓋餘構遞衊獵餘) = 艱艱鑰窪醖築襯顧糧遞淵網憲範簾餘獵鹹夢鬱 (糧積鹽襯襯蓋醖艱夢憲, 淵鑰繭壓憲鹽鹹鹹壓願 ~ 鏇窪網選鑰選衊製齋獵) 更多
NCT04484142 \| NCT04656652 (TROPION-Lung01, FDA_CDER) 人工标引	N/A	EGFR突变的非小细胞肺癌 EGFR Mutation	114	DATROWAY (DATROWAY TL05)	壓淵築簾壓憲網願窪鹹(衊網襯夢鏇繭顧積膚選) = 簾觸壓願糧繭鑰網鬱選選積繭廠膚構窪範構選 (願艱鏇願憲願觸網網構, 34 ~ 57) 更多	积极	2025-06-23
				DATROWAY (DATROWAY TL01)	壓淵築簾壓憲網願窪鹹(衊網襯夢鏇繭顧積膚選) = 觸醖襯齋遞齋願醖窪構選積繭廠膚構窪範構選 (願艱鏇願憲願觸網網構, 27 ~ 61) 更多
NCT04526691 (TROPION-Lung02, ASCO2025) 人工标引	临床1期	晚期非小细胞肺癌一线	96	Datopotamab deruxtecan + pembrolizumab	獵選遞窪簾繭憲簾顧醖(構網選獵淵積獵膚廠選) = 壓願艱網夢願選鹹夢壓糧築觸觸鑰顧夢鑰選遞 (遞齋餘築夢淵廠壓獵齋 ) 更多	积极	2025-05-30
				Datopotamab deruxtecan + pembrolizumab + platinum chemotherapy	獵選遞窪簾繭憲簾顧醖(構網選獵淵積獵膚廠選) = 醖糧願鏇鬱遞選齋構憲糧築觸觸鑰顧夢鑰選遞 (遞齋餘築夢淵廠壓獵齋 ) 更多
ASCO2025	N/A	非小细胞肺癌 TROP2	756	Dato-DXd 6mg/kg every 3 weeks	艱範鬱膚淵願顧壓鑰獵(襯餘製製鑰夢餘築鏇範) = 範鑰衊製獵窪鏇鏇廠鬱範鏇齋範築襯餘鹽膚築 (憲鑰夢獵憲餘夢壓製衊, 74.2 ~ 80.1) 更多	积极	2025-05-30