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更新于：2026-09-05
ATG-022
更新于：2026-09-05
概要
基本信息
药物类型 ADC |
别名 ATG 022、ATG-022、ATG-022 ADC + [1] |
作用方式 抑制剂 |
作用机制 CLDN18.2抑制剂(Claudin 18.2蛋白抑制剂)、微管蛋白抑制剂 |
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 |
特殊审评孤儿药 (美国)、突破性疗法 (中国) |
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结构/序列
分子式C11H22N4O4 |
InChIKeyAGGWFDNPHKLBBV-YUMQZZPRSA-N |
CAS号159858-33-0 |
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关联
3
项与 ATG-022 相关的临床试验NCT07795346
A Randomized, Controlled, Open-label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ATG-022 Compared With Investigator's Choice of Treatment in Subjects With Claudin18.2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
NCT07327229
A Phase Ib/II Study of ATG-022 Plus Pembrolizumab With/Without Chemotherapy in Participants With Claudin (CLDN) 18.2-positive, HER2-negative, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
NCT05718895
An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced/Metastatic Solid Tumors
100 项与 ATG-022 相关的临床结果
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100 项与 ATG-022 相关的转化医学
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100 项与 ATG-022 相关的专利（医药）
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523
项与 ATG-022 相关的文献（医药）2025-12-31mAbs
A bispecific antibody-drug conjugate targeting pCAD and CDH17 has antitumor activity and improved tumor-specificity
Article
作者: Gesner, Thomas ; Logel, Claude ; Xie, Kathleen T. ; Cebe, Regis ; Wu, Nila C. ; Li, Xun ; Shi, Xingyi ; Velazquez, Roberto ; Simmons, Quincey ; Tschantz, William R. ; Korn, Joshua ; Sagar, Vivek ; Hainzl, Dominik ; Barzaghi-Rinaudo, Patrizia ; Malamas, Anthony ; Mercan, Samuele ; Green, Andrew ; McLaughlin, Margaret ; Huber, Thomas ; Mueller, Kathrin ; D’Alessio, Joseph A. ; Synan, Alyssa
P-cadherin (pCAD) and LI-cadherin (CDH17) are cell-surface proteins belonging to the cadherin superfamily that are both highly expressed in colorectal cancer. This co-expression profile presents a novel and attractive opportunity for a dual targeting approach using an antibody-drug conjugate (ADC). In this study, we used a unique avidity-driven in vitro screening approach to generate pCAD x CDH17 bispecific antibodies that selectively target cells expressing both antigens over cells expressing only pCAD or only CDH17. Based on in vitro binding and inhibition of cell proliferation results, we selected a lead bispecific antibody to link to the cytotoxic payload monomethyl auristatin E (MMAE) to generate a pCAD x CDH17 bispecific MMAE ADC. In in vivo dual flank mouse models, we demonstrated antitumor activity of the bispecific ADC in tumors expressing both antigens but not in tumors expressing only pCAD or only CDH17. Overall, the preclinical data presented here support the proof-of-concept bispecific antibody discovery approach, demonstrating a rational design for screening antibodies by prioritizing cross-arm avid IgGs to target dual-positive cells.
2025-06-12ACS Medicinal Chemistry Letters
Site-Selective Anti-PD-L1 Antibody–MMAE Conjugate for Enhanced NSCLC Therapy
Article
作者: Sang J. Chung ; Se Jeong Kwon ; Jinyoung Son
Nonsmall cell lung cancer (NSCLC) presents significant therapeutic challenges, causing advancements in targeted therapies. We have developed a site-selective antibody-drug conjugate (ADC), durvalumab-monomethyl auristatin E (MMAE), with a drug-antibody ratio (DAR) of 4, specifically targeting programmed death-ligand 1 (PD-L1), aimed at enhancing NSCLC therapy. Utilizing the innovative AbClick Pro linker, this ADC ensures stable, site-specific conjugation of MMAE to durvalumab, preserving antibody functionality and integrity. In vivo studies demonstrate that durvalumab-MMAE achieves substantial tumor growth inhibition in NSCLC xenograft models, with an impressive tumor growth inhibition rate of over 60% at lower dosages without significant toxicity. These results, combined with a favorable pharmacokinetic profile featuring extended half-life and low clearance, highlight the potential of durvalumab-MMAE (DAR4) as a potent next-generation ADC for treating PD-L1-expressing cancers, offering a promising avenue for improved NSCLC patient outcomes.
2025-06-02MOLECULAR PHARMACEUTICS
Cleavable PEGylation Enhances the Antitumor Efficacy of Small-Sized Antibody–Drug Conjugates
Article
作者: Ding, Yu ; Zhang, Hongru ; Yang, Liu ; Yin, Dongming ; Hong, Zhangyong ; Han, Jiani ; Wang, Jian ; Wang, Xi ; Xu, Keyuan
Antibody-drug conjugates (ADCs) have emerged as a promising class of cancer therapeutics. However, traditional ADCs are often limited by poor tumor penetration due to their large molecular size. While the use of small-sized antibody fragments or analogues can improve tumor permeability, this approach typically results in an extremely shortened blood circulation half-life, which diminishes the therapeutic benefits and brings other metabolic challenges. In addition, the expression of target antigens on normal tissues often leads to unnecessary on-target/off-tumor toxicity. To address these issues, we developed a novel tumor site-specific cleavable PEGylation strategy for small-sized ADC design. The small ADC molecule ZHER2-MMAE was site-specifically PEGylated at its N-terminus with a 20 kDa polyethylene glycol (PEG) chain and a uPA (LSGRSDNH) cleavage sequence was inserted between them (PEG20k-U-ZHER2-MMAE). Our results showed that PEG20k-U-ZHER2-MMAE achieves a similar half-life extension (6.4 and 6.0 h) compared to the conventional PEG20k-ZHER2-MMAE, both representing about a 26-fold improvement compared to ZHER2-MMAE. Importantly, PEG20k-U-ZHER2-MMAE exhibited significantly higher drug accumulation at the tumor site, leading to the complete eradication of NCI-N87 and SK-OV-3 tumors at a dose of 5.5 mg/kg. Additionally, it demonstrated a maximum tolerated dose (MTD) exceeding 35 mg/kg, while the noncleavable PEG20k-ZHER2-MMAE could only slow tumor growth. In addition, compared to ZHER2-MMAE, the in vitro cytotoxic activity of PEG20k-ZHER2-MMAE or PEG20k-U-ZHER2-MMAE was reduced by about 50 times, with the latter expected to reduce the on-target/off-tumor side effects due to the specific activation by uPA at tumor sites. These data fully demonstrate the effectiveness and high safety of our tumor-specific cleavable PEGylation strategy, supporting the potential in the development of next-generation ADCs for cancer therapy.
100 项与 ATG-022 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 |
|---|---|---|---|---|
| 晚期胃食管交界处腺癌 | 临床3期 | 中国 | 2026-09-01 | |
| CLDN18.2阳性胃食管交界处腺癌 | 临床3期 | 中国 | 2026-09-01 | |
| 胃食管交界处腺癌 | 临床3期 | 中国 | 2026-05-28 | |
| CLDN18.2阳性胃癌 | 临床2期 | 中国 | 2026-02-27 | |
| 转移性胃食管结合部腺癌 | 临床2期 | 中国 | 2026-02-27 | |
| 转移性胃癌 | 临床2期 | 中国 | 2024-03-20 | |
| 转移性胃癌 | 临床2期 | 澳大利亚 | 2024-03-20 | |
| 晚期恶性实体瘤 | 临床1期 | 澳大利亚 | 2023-03-01 | |
| CLDN18.2阳性实体瘤 | 临床1期 | 澳大利亚 | 2023-03-01 | |
| 胃癌 | 临床前 | 美国 | 2023-05-22 |
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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 | 肿瘤 CLDN18.2 Positive | - | (CLDN18.2中高表达患者 (IHC 2+ > 20%)) | 窪築廠衊繭繭淵餘鏇顧(膚齋築觸鏇選窪築糧膚) = 遞顧鏇醖鏇願壓積蓋襯 衊餘廠鏇獵糧衊鬱餘餘 (鑰積鬱廠製築製壓衊蓋 ) 更多 | 积极 | 2026-01-06 | |
(CLDN18.2中高表达患者 (IHC 2+ > 20%)) | 窪築廠衊繭繭淵餘鏇顧(膚齋築觸鏇選窪築糧膚) = 憲醖淵膚構齋膚艱淵網 衊餘廠鏇獵糧衊鬱餘餘 (鑰積鬱廠製築製壓衊蓋 ) 更多 | ||||||
NEWS 人工标引  | 临床1/2期 | CLDN18.2阳性胃癌 CLDN18.2 Positive | 76 | ATG-022 2.4mg/kg (CLDN18.2表达中高(免疫组化[IHC]2+>20%)) | 蓋膚鬱鹽鑰壓鏇鏇窪艱(鬱繭鹹製夢衊糧憲齋窪) = 齋鹹鏇衊範簾淵願憲糧 壓餘製獵夢糧糧範網鏇 (醖齋膚遞構鹽觸艱夢憲 ) 更多 | 积极 | 2025-11-25 |
ATG-022 1.8mg/kg (CLDN18.2表达中高(免疫组化[IHC]2+>20%)) | 蓋膚鬱鹽鑰壓鏇鏇窪艱(鬱繭鹹製夢衊糧憲齋窪) = 構築齋膚鏇衊膚醖夢願 壓餘製獵夢糧糧範網鏇 (醖齋膚遞構鹽觸艱夢憲 ) 更多 | ||||||
临床1/2期 | 81 | (CLDN18.2 Moderate-to-high expression (IHC 2+ > 20%)) | 願網獵壓鹽鑰齋夢顧餘(餘蓋積齋憲糧醖衊構壓) = 鑰繭構鬱鬱餘鹹範製築 獵憲夢糧艱窪醖壓艱鹽 (製憲觸糧鹹鹹醖鬱齋築 ) 更多 | 积极 | 2025-08-19 | ||
(CLDN18.2 Moderate-to-high expression (IHC 2+ > 20%)) | 願網獵壓鹽鑰齋夢顧餘(餘蓋積齋憲糧醖衊構壓) = 膚蓋顧觸願鑰網築願糧 獵憲夢糧艱窪醖壓艱鹽 (製憲觸糧鹹鹹醖鬱齋築 ) 更多 | ||||||
临床1期 | CLDN18.2阳性实体瘤 CLDN18.2 Positive | - | (CLDN18.2 IHC 2+ ≥ 20%) | 觸襯獵淵繭鏇簾艱艱襯(鬱鑰遞築網構艱齋鬱蓋) = 淵憲築齋構遞範艱膚鏇 糧獵餘鹽鑰鹹艱範觸蓋 (網膚積廠網觸蓋鏇願夢 ) 更多 | 积极 | 2025-05-20 | |
(CLDN18.2 IHC 2+ < 20%) | 觸襯獵淵繭鏇簾艱艱襯(鬱鑰遞築網構艱齋鬱蓋) = 壓窪餘齋網餘廠糧鏇獵 糧獵餘鹽鑰鹹艱範觸蓋 (網膚積廠網觸蓋鏇願夢 ) 更多 | ||||||
临床1期 | 37 | (dose escalation phase) | 願鏇醖獵構選網鑰簾鏇(膚鑰壓艱襯積積醖膚顧) = in dose escalation, 1 DLT of grade 3 nausea found at 3 mg/kg among 6 pts 糧獵積襯醖鑰夢糧廠願 (淵選醖製鬱餘醖鹽遞糧 ) 更多 | 积极 | 2025-01-23 | ||
(dose expansion phase) | |||||||
NEWS 人工标引 | 临床2期 | 胃癌 CLDN6 Positive | 12 | 製遞鹽遞淵遞壓憲膚鏇(積襯襯遞鹽廠顧觸繭鑰) = 壓繭蓋餘夢構襯簾鏇醖 廠窪醖膚鹽鏇齋蓋獵齋 (餘築餘窪鬱淵網衊積製 ) 更多 | 积极 | 2024-08-23 | |
(Claudin18.2中高表达) | 製遞鹽遞淵遞壓憲膚鏇(積襯襯遞鹽廠顧觸繭鑰) = 構顧簾廠鹽蓋製膚齋鑰 廠窪醖膚鹽鏇齋蓋獵齋 (餘築餘窪鬱淵網衊積製 ) 更多 | ||||||
临床1期 | 实体瘤 CLDN18.2 Positive | 10 | ATG-022 0.9 mg/kg | 簾積範積壓夢艱築鏇鹽(廠獵遞範鑰觸壓築選鏇) = 衊鏇窪製餘艱構衊網顧 繭願淵餘鬱襯艱壓遞選 (夢繭壓鬱積衊艱鬱顧築 ) | - | 2024-05-24 | |
ATG-022 1.8 mg/kg | 簾積範積壓夢艱築鏇鹽(廠獵遞範鑰觸壓築選鏇) = 夢構鹹襯鹹鏇顧艱鑰淵 繭願淵餘鬱襯艱壓遞選 (夢繭壓鬱積衊艱鬱顧築 ) 更多 |
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