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更新于：2025-11-24
Anbenitamab repodatecan
更新于：2025-11-24
概要
基本信息
药物类型 ADC |
别名 JSKN 003、JSKN-003、JSKN003 |
作用方式 拮抗剂、抑制剂 |
作用机制 HER2拮抗剂(受体蛋白酪氨酸激酶 erbB-2拮抗剂)、TOP1抑制剂(DNA拓扑异构酶I抑制剂) |
在研适应症 |
非在研适应症- |
原研机构 |
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评快速通道 (美国)、孤儿药 (美国)、突破性疗法 (中国) |
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结构/序列
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Sequence Code 18481L
来源: *****
Sequence Code 525560003H
来源: *****
Sequence Code 525560004H
来源: *****
关联
14
项与 Anbenitamab repodatecan 相关的临床试验ChiCTR2500111317
A Phase Il Clinical Study to Evaluate the Safety,Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients With Advanced Non-Small Cell Lung Cancer
NCT06998771
A Phase II Trial to Evaluate the Safety and Efficacy of JSKN003 Combination Therapy as First-line Treatment in HER2-positive Unresectable Locally Advanced or Metastatic Gastric Cancer or Resectable Gastric Cancer
CTR20251968
评价JSKN003联合治疗在HER2阳性不可切除局部晚期或转移性一线胃癌治疗，或可切除胃癌围手术期治疗中的安全性和有效性的II期临床研究
100 项与 Anbenitamab repodatecan 相关的临床结果
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100 项与 Anbenitamab repodatecan 相关的转化医学
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100 项与 Anbenitamab repodatecan 相关的专利（医药）
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11
项与 Anbenitamab repodatecan 相关的文献（医药）2024-11-14JOURNAL 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.
2024-10-01BIOORGANIC 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.
2024-10-01MOLECULAR 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.
100 项与 Anbenitamab repodatecan 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 晚期 HER2 阳性乳腺癌 | 临床3期 | 中国 | 2025-02-18 | |
| HER2阳性乳腺癌 | 临床3期 | 中国 | 2025-02-18 | |
| 铂耐药性输卵管癌 | 临床3期 | 中国 | 2025-01-20 | |
| 铂耐药上皮性卵巢癌 | 临床3期 | - | 2025-01-15 | |
| 铂耐药性卵巢癌 | 临床3期 | - | 2025-01-15 | |
| 铂类耐药性原发性腹膜癌 | 临床3期 | - | 2025-01-15 | |
| 复发性铂耐药性输卵管癌 | 临床3期 | - | 2025-01-15 | |
| HER2低表达乳腺癌 | 临床3期 | 中国 | 2023-11-14 | |
| 晚期非小细胞肺癌 | 临床2期 | 中国 | 2025-09-23 | |
| HER2阳性胃癌 | 临床2期 | 中国 | 2025-06-12 |
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临床结果
临床结果
适应症
分期
评价
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临床1/2期 | 21 | JSKN003 6.3 mg/kg Q3W | 範鑰觸夢衊餘艱簾構鬱(遞餘願顧製夢廠憲襯願) = 顧淵餘積獵艱積艱壓範 襯壓蓋夢顧積鏇選積糧 (鏇衊鑰選襯壓築壓夢網 ) 更多 | 积极 | 2025-10-17 | ||
临床1/2期 | 铂耐药性卵巢癌 HER2 Expression | 46 | 憲鏇範構夢製淵觸衊鏇(壓壓鏇範積壓餘廠膚蓋) = 膚觸繭積鬱願範鏇鑰夢 壓壓鏇醖簾觸積壓衊願 (遞鏇鏇鑰衊憲鬱衊簾齋, 48.8 ~ 78.1) 更多 | 积极 | 2025-05-30 | ||
(HER2 IHC 1+/2+/3+) | 憲鏇範構夢製淵觸衊鏇(壓壓鏇範積壓餘廠膚蓋) = 蓋憲糧遞憲鬱鹹遞選遞 壓壓鏇醖簾觸積壓衊願 (遞鏇鏇鑰衊憲鬱衊簾齋, 46.5 ~ 90.3) 更多 | ||||||
临床1/2期 | 40 | 鹹餘網範齋襯遞齋鑰構(鑰夢製網簾蓋憲糧鹹築) = ILD occurred in 3 (7.5%; n = 2 G1; n = 1 G2) pts 選醖餘遞鬱窪製觸鑰選 (鑰糧遞積夢鹹糧積鏇鹹 ) 更多 | 积极 | 2025-05-30 | |||
临床1/2期 | 71 | 齋廠繭壓鏇壓範獵壓選(蓋簾糧觸襯網範膚齋願) = ILD occurred in three patients (4.2%), all Grade 1-2, with no Grade ≥3 events 蓋糧齋觸繭壓鏇齋襯淵 (醖範衊壓淵齋廠餘糧齋 ) 更多 | 积极 | 2025-05-30 | |||
临床1/2期 | HER2阳性实体瘤 HER2 Positive | 29 | 觸淵築醖繭齋遞獵壓範(簾積遞蓋觸積艱獵襯糧) = 鑰衊壓範範膚網糧鬱遞 襯膚蓋獵範窪範鏇醖鬱 (壓遞艱夢夢窪範鏇鑰淵 ) 更多 | 积极 | 2024-09-17 | ||
临床1/2期 | 卵巢癌 HER2 | 50 | 衊鹹襯願蓋築鹽廠範襯(糧壓築選願製夢鬱範淵) = 遞網顧蓋製淵鑰衊窪鑰 築淵築積積積鹽選醖衊 (製壓衊艱艱衊齋糧齋鹽 ) 更多 | 积极 | 2024-09-17 | ||
临床1/2期 | HER2阳性实体瘤 HER2 Positive | 24 | 憲蓋齋鹽觸憲糧鏇簾選(餘鹹網築觸艱鹹遞構糧) = 鏇構鑰築鑰鏇蓋廠廠膚 繭壓鏇鹽範廠夢淵糧醖 (蓋廠膚艱夢艱鹽醖糧選 ) 更多 | 积极 | 2024-09-14 | ||
临床1/2期 | 27 | 繭艱簾蓋獵糧衊製淵夢(選壓顧膚壓糧積膚製範) = 醖齋壓憲廠夢襯範蓋構 憲衊鏇鏇簾艱艱艱鑰夢 (廠積選鏇淵獵夢餘積遞 ) 更多 | 积极 | 2024-09-14 | |||
(HER2 IHC 1+、2+ 和 3+) | 憲積糧蓋構繭範廠壓鬱(廠繭壓選壓餘構獵壓願) = 積獵繭願衊鹽糧壓網窪 憲選觸糧鑰襯蓋製獵夢 (齋淵觸膚積鹹憲獵願夢 ) | ||||||
临床1/2期 | 实体瘤 HER2 Expression | 46 | 鏇襯觸醖網鏇遞艱顧觸(蓋憲網觸憲糧選壓製鹽) = 夢範糧齋繭鹹鑰遞網遞 齋鏇簾繭淵艱餘積鏇衊 (簾顧壓窪鏇衊遞構願鬱, 35.8 ~ 66.3) 更多 | 积极 | 2024-06-04 | ||
临床1/2期 | 实体瘤 HER2-expressing | HER2-mutant | 46 | 壓衊繭製願願襯艱鏇構(鏇夢遞構遞衊糧齋鏇鏇) = No pts experienced DLT or interstitial lung disease, and no TRAE led to death or discontinuation 糧範襯製築願蓋鹹壓遞 (糧範壓遞網膚膚築餘襯 ) 更多 | 积极 | 2024-05-24 | ||
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