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

This is 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

开始日期2026-03-01

申办/合作机构

德琪医药有限公司

[+1]

NCT05718895

/ Recruiting临床1期

An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced/Metastatic Solid Tumors

This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with Advanced/metastatic Solid Tumors

开始日期2023-03-27

申办/合作机构

德琪医药有限公司

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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409

项与 ATG-022 相关的文献（医药）

2025-06-12·ACS Medicinal Chemistry Letters

Site-Selective Anti-PD-L1 Antibody–MMAE Conjugate for Enhanced NSCLC Therapy

Article

作者: Kwon, Se Jeong ; Son, Jinyoung ; Chung, Sang J.

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.

2025-06-01·Pharmaceutical Fronts

Design, Development, and Antitumor Potential of CD228-Targeted Antibody–Drug Conjugates

作者: Xie, Liping ; Qiu, Haitao

Abstract:

Melanotransferrin (CD228) is a membrane glycoprotein involved in tumor growth and metastasis and is highly expressed in various solid tumors. Despite its tumor-specific nature, no antibody drugs targeting CD228 are currently available. This study aimed to develop a humanized CD228 monoclonal antibody and its antibody–drug conjugate (ADC) to evaluate in vitro cytotoxicity and in vivo antitumor efficacy against melanoma. In this work, mice were immunized with the extracellular domain of CD228, and specific antibodies were screened using hybridoma technology, followed by humanization. The humanized antibody was conjugated to monomethyl auristatin E (MMAE) with a citrulline–valine linker and purified by protein A chromatography. The drug–antibody ratio (DAR) and purity were analyzed using hydrophobic interaction chromatography and size-exclusion chromatography. CCK8 assay was performed to assess cytotoxicity against tumor cells, and antibody-dependent cell-mediated cytotoxicity (ADCC) was assessed using Jurkat cells. An A2058 melanoma xenograft model was used to examine in vivo efficacy. This work identified a humanized antibody, Ab-2F6A1, with high CD228 binding affinity, with EC50 values of 1.746 ng/mL (protein binding activity) and 83.8 ng/mL (cell binding activity). The ADC, Ab-2F6A1-VcMMAE, had an average DAR of 4.9026 and a purity of 98.24% and showed significant in vitro cytotoxicity against melanoma, breast, and colon cancer cells. Ab-2F6A1-VcMMAE has a stronger ADCC effect compared with the positive control (Ab-hI49-VcMMAE), and exhibited superior melanoma tumor inhibition in vivo. Given the above, a novel humanized anti-CD228 antibody and its ADC were successfully developed. The ADC demonstrated strong antigen binding, in vitro antitumor activity, ADCC effects, and superior in vivo melanoma inhibition, supporting CD228 as a promising therapeutic target.

2025-06-01·JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

A translational physiologically-based pharmacokinetic model for MMAE-based antibody-drug conjugates

Article

作者: Shah, Dhaval K ; Chang, Hsuan-Ping

Abstract:

The objective of this work was to develop a translational physiologically-based pharmacokinetic (PBPK) model for antibody-drug conjugates (ADCs), using monomethyl auristatin E (MMAE)-based ADCs. A previously established dual-structured whole-body PBPK model for MMAE-based ADCs in mice was scaled to higher species (i.e., rats and monkeys) and humans. Species-specific physiological and drug-related parameters for the payload and antibody backbone of ADCs were obtained from literature. Parameters associated with payload release, including the deconjugation rate, were optimized using an allometric scaling approach, and antibody degradation rate was adjusted to account for the enhanced clearance of ADCs due to conjugation across different species. The translational PBPK model predicted the PK profiles for various ADC analytes in rats, monkeys, and humans reasonably well. The optimized PBPK model suggested decreased rate of deconjugation for ADCs in higher species, whereas the effects of payload conjugation on ADC clearance were more pronounced in higher species and humans. The translational PBPK model presented here may enable prediction of different ADC analyte PK at the site-of-action, offering valuable insights for the development of exposure-response relationships for ADCs. The modeling framework presented here can also serve as a platform for the development of PBPK model for other ADCs.

146

项与 ATG-022 相关的新闻（医药）

2026-01-19

·Biotech前瞻

去掉传统化疗丨礼新CLDN18.2 ADC+免疫布局晚期胃癌一线大三期

点击蓝字关注我们本期看点过去一年，晚期胃癌治疗正在悄然完成一场结构性变化：CLDN18.2 从“新兴靶点”迅速跃升为一线胃癌治疗中的核心变量，而 ADC 正在成为承载这一靶点价值的关键技术形态。且与 CLDN18.2 单抗一致（26 ASCO GI丨佐妥昔单抗+免疫+化疗II期研究数据惊艳，有望重塑晚期胃癌一线治疗格局），正在布局胃癌一线大三期。本期内容 01 礼新医药丨BMS丨LM-302 02 国内企业扎推布局CLDN18.2 ADC 03 安斯泰来 CLDN18.2 单抗三联数据将揭晓 04 总结与展望【01 礼新医药丨BMS丨LM-302】近日，礼新医药在CDE药物临床试验登记与信息公示平台网站上，登记了一项CLDN18.2 ADC药物LM-302，联合百济神州PD-1抗体替雷利珠，在既往未接受过系统性治疗的CLDN18.2阳性的局部晚期不可切除或者转移性胃或胃食管交界处腺癌受试者中，启动一项随机、开放、多中心、阳性对照的III期临床研究CTR20260165，这也是首款CLDN18.2 ADC药物进入一线胃癌的三期临床实验。 2022年5月，礼新医药与Turning Point（后被BMS收购）达成合作，首付款2,500万美元，里程碑总额超10亿美元（研发里程碑1.95亿+销售分成）。权益分配：礼新保留大中华区及韩国权益，BMS主导全球其他区域开发。孤儿药资格：FDA授予胰腺癌、胃癌/GEJ腺癌及胆道癌三项资格（2022年）。 III期启动 2024年4月8日公示III期试验（NCT06351020），针对三线CLDN18.2阳性胃癌/GEJ腺癌，对比阿帕替尼或伊立替康。全球覆盖：BMS同步推进国际多中心III期（含美国、欧洲）。无独有偶，在 2025 年 ESMO ASIA 大会上，中山大学肿瘤防治中心阮丹云教授公布了君实生物 CLDN18.2 ADC 药物 JS107 联合特瑞普利单抗 + XELOX 一线治疗不可切除或转移性胃癌/胃食管结合部腺癌的 I 期数据。在 CLDN18.2 高表达人群（≥40% 2+）中，ORR 达 86.7%，DCR 达 100%，中位 PFS 11.14 个月；在整体 CLDN18.2 阳性人群中同样观察到稳定的抗肿瘤活性。安全性方面，在 2 mg/kg 剂量联合 75%–100% 剂量 XELOX 条件下，≥3 级不良事件主要集中于中性粒细胞和血小板减少，整体符合 ADC 联合化疗的可管理安全特征。这组数据的意义，不仅在于疗效数据的惊艳，更在于它用一线真实数据首次系统验证了“CLDN18.2 ADC + PD-1 + 化疗”作为一线强化方案的可行性。随着Ⅲ期临床试验的推进，若安全性和疗效得到进一步验证，这一三联疗法有望改写晚期CLDN18.2阳性胃癌的治疗指南。即晚期胃癌一线的治疗结构，有望从“化疗+免疫”，向“靶向+免疫+化疗”的新框架演进。 02 国内企业扎推布局CLDN18.2 ADC JS107的破局并非偶然，而是过去两年国内CLDN18.2 ADC管线系统化推进、集体进入临床验证期的必然结果。目前，国内进度最快的是信达生物IBI343。其采用TOPO1抑制剂Exatecan作为载荷，并进行了Fc段沉默化改造。在晚期胃癌中，其针对CLDN18.2高表达（≥75%肿瘤细胞染色强度2+/3+）人群的早期数据显示出明确疗效信号（ORR约30%，mPFS 5-6个月）。更具战略意义的是，IBI343在素有“癌王”之称的胰腺癌（PDAC）中取得了突破：在CLDN18.2高表达（≥60%）患者中，确认的ORR达22.7%，DCR为81.8%，中位OS达8.5个月。这使其成为全球在该适应症上进展最快的CLDN18.2 ADC之一。目前，IBI343已同步启动针对胃癌和胰腺癌的全球多中心III期研究，并凭借PDAC数据先后获得NMPA突破性治疗认定和FDA快速通道资格，目标直指成为全球首个在胰腺癌获批的CLDN18.2 ADC，旨在开辟全新的治疗市场。德琪医药ATG-022的临床数据最显著的特点是疗效对CLDN18.2表达水平的宽泛依赖性。在CLINCH I/II期研究中，不仅在中高表达人群（IHC 2+ >20%）中观察到约40%的ORR，更在CLDN18.2低及超低表达（IHC 2+ ≤20%）患者中仍实现了33.3%的ORR，并出现了完全缓解（CR）。这一定位使其有望覆盖更广泛的患者群体。基于此，ATG-022已获NMPA突破性治疗认定，其开发策略清晰系统：在布局三线单药及二线联合的同时，已启动一线联合帕博利珠单抗及化疗的全球研究。荣昌生物的CLDN18.2 ADC药物RC118，在II期研究中与自研的PD-1/VEGF双抗RC148联合，在CLDN18.2阳性晚期胃癌患者中取得了ORR 57.1%、DCR 95.2%的优异数据。更具前瞻性的是，荣昌同期布局了全球领先的HER2/CLDN18.2双特异性抗体HC-2G4S，旨在攻克HER2与CLDN18.2共表达（约占胃癌患者5%-10%）这一细分且顽固的临床难题，构建下一代技术护城河。此外，中国CLDN18.2 ADC的平台技术价值已获得全球顶级药企的持续认可与争夺。康诺亚/乐普生物的CMG901与礼新医药的LM-302，分别以高达11.88亿和超10亿美元的重磅交易授权给阿斯利康和百时美施贵宝（BMS），并已由合作方主导开展全球III期临床研究。信诺维的XNW27011在2025年被安斯泰来以独家许可协议收入囊中，成为该巨头在CLDN18.2领域（除其自研单抗佐妥昔单抗外）的关键ADC布局。XNW27011已获得FDA快速通道资格，并正在中国开展针对局部晚期或转移性胃癌/胃食管结合部腺癌的III期临床试验。安斯泰来的双重布局尤其值得玩味：其一边推进自研CLDN18.2单抗佐妥昔单抗的“单抗+免疫+化疗”三联方案数据，另一边又通过BD将中国ADC技术纳入版图。这既印证了CLDN18.2靶点一线三联疗法已成为国际共识，也凸显了中国在ADC技术迭代上的领先优势正被巨头以“资本+合作”的方式快速整合。综上所述，从信达的全球攻坚、德琪的广谱覆盖、荣昌的联合与迭代，到康诺亚/乐普、礼新、信诺维的技术接连出海，中国CLDN18.2 ADC领域已形成层次分明、优势互补、且与国际巨头深度绑定的战略阵列。这场竞争，不仅是产品效力的比拼，更是临床开发策略、国际化能力、管线生态与产业资本整合能力的全面较量。【03 安斯泰来 CLDN18.2 单抗三联数据将揭晓】在国产ADC全面进击一线治疗的同时，跨国药企同样在这一核心靶点上加注了战略筹码。安斯泰来作为CLDN18.2赛道的先行者，其自研的CLDN18.2单抗佐妥昔单抗，在“单抗+化疗”方案已获全球批准的基础上，正将战线前移至更具前景的“单抗+PD-1+化疗”一线三联方案，相关关键临床数据即将揭晓。这标志着，晚期胃癌一线治疗围绕CLDN18.2靶点的竞争，正清晰地分化为两条并行的技术路径：以国产ADC（如JS107、IBI343等）为代表的“靶向递送+强效细胞毒”路线：核心是通过抗体将高活性化疗药物（如MMAE、Exatecan）精准递送至肿瘤细胞内部，实现“内部爆破”式杀伤，并与免疫治疗、基础化疗形成机制协同。以安斯泰来为主导的“单抗+免疫+化疗”强化路线：侧重于通过单抗阻断CLDN18.2信号通路、并可能激发抗体依赖性细胞介导的细胞毒性（ADCC）等免疫效应，再联合PD-1抑制剂与化疗，实现多机制叠加。二者的根本差异在于是否通过ADC技术前置性引入强效细胞毒载荷，这将直接影响疗效强度、安全性谱和耐药机制。值得注意的是，“单抗+免疫+化疗”路径的潜力已获初步临床验证。例如，在2025年ASCO年会上公布的TranStar102研究显示，创胜集团的CLDN18.2单抗Osemitamab（TST001）联合纳武利尤单抗与CAPOX化疗，一线治疗CLDN18.2中高表达晚期胃癌患者，取得了确认的客观缓解率（cORR）68%、中位无进展生存期（mPFS）16.6个月、中位总生存期（mOS）21.7个月的卓越数据。尤为关键的是，该方案在大量PD-L1低表达患者中同样有效，展现了其广谱潜力。目前，这一路径已形成国内外企业共同推进的集群态势。除安斯泰来外，多家中国公司也已将其CLDN18.2单抗推至三期临床，旨在优化人群与方案：创胜集团Osemitamab (TST001)：全球三期研究（TranStar301）已启动，联合纳武利尤单抗+CAPOX，对比标准免疫化疗，其入组标准（CLDN18.2阳性定义为≥10%肿瘤细胞1+）旨在覆盖更广泛人群。奥赛康ASKB589：全球三期研究采用“ASKB589+CAPOX+替雷利珠单抗”对比标准免疫化疗，针对CLDN18.2中高表达（≥40%肿瘤细胞2+/3+）人群。明济生物FG-M108：三期研究聚焦于CLDN18.2阳性且PD-L1低表达（CPS<5）这一细分人群，评估FG-M108联合CAPOX的疗效。未来一线治疗的真实格局，将取决于这两条路径在疗效（ORR、PFS、OS）、安全性、用药便捷性、可及性与支付成本等多维度的直接或间接竞争。国产ADC凭借其强效杀伤特性迅猛前移，而单抗路线则凭借已验证的成药性、与免疫治疗的协同潜力及更低的毒性风险，同样在快速迭代。这种技术与商业的双轨竞赛，最终将共同推动晚期胃癌一线治疗标准的全面升级，并为不同特征的患者提供更丰富的分层治疗选择。 04 总结与展望总的来说，CLDN18.2靶向联合免疫治疗和化疗的三联方案目前仍处于临床探索阶段，并非当前的标准治疗选择。患者是否适合参与此类研究，或选择何种治疗方案，务必由专业的肿瘤科医生根据患者的具体情况（如CLDN18.2表达水平、PD-L1表达状态、体力状况、既往治疗史等）综合判断。 ★

临床3期孤儿药抗体药物偶联物并购引进/卖出

2026-01-17

·辰小飞的log

JMP2026——德琪医药All in TCE平台

美国西部时间2025年1月15日，一年一度的生物制药盛会J. P. Morgan Healthcare Conference大会于旧金山落幕。期间除了Boston Scientific以145亿美元收购聚焦于血管/神经血管领域的Penumbra之外，无其他超级重磅的并购出现。据悉，更多的交易和沟通偏向于非公开场合，让备受期待的“生物医药春晚”略显平淡，然而在这一份平淡的背后是更丰富的临床数据的展示，是更多Biotech开启强劲盈立的时刻，也是新技术新疗法开始展露头角的时刻。新兴领域之外，减重、TCE以及ADC依旧是最受关注的全球赛道。新兴领域中再生医学备受关注，其中Vericel上调了MACI在膝关节软骨损伤的销售指引，2026年将继续双位数增长；小核酸领域Arrowhead旗下的Redemplo获FDA批准上市，而Arrowhead在JPM上披露Redemplo在适应症SHTG上的III期顶线数据将于2026年Q3公布，继而在Q4提交sNDA。减重领域，Amgen更新了MariTide，一款GLP-1/GIP双激动剂，在减重维持中的数据，是Amgen在减重领域的重磅产品；与此同四诺和诺德以及礼来都在积极推进口服减重药物的商业化，其中Novo表示虽然口服制剂的渗透仍然需要时间但是具备潜力；Madrigal的口服GLP-1管线将在2026年Q2进入临床I期，而礼来与中外制药株式会社共同开发的Orforglipron于1月13日向NMPA提交了上市申请。 TCE领域，强生在ASH上公布了BCMA/CD3令人经验的数据之后，在JPM上更新了另一款GPRC5D/BCMA/CD3有望在2026年进入III期临床，旨在对比 JNJ-79635322与抗BCMA×CD3双特异性抗体在接受过至少 3线既往治疗（含蛋白酶体抑制剂、免疫调节剂以及抗CD38抗体）RRMM 患者中的疗效。 ADC领域，Merck CEO强调Keytruda仍是未来管线的核心，阿斯利康的sone-vedo（Claudin 18.2）在二线胃癌的数据也将在2026年H1读出。ADC领域的持续加码对于MNC而言不是选择题，而是必选题，罗氏与宜联生物就一款靶向B7-H3的临床后期ADC管线达成的交易则是这种趋势的最好注脚。双抗领域的TCE是另一种形式的“体内细胞治疗”，强生的BCMA/CD3已经向全球展现出了媲美传统CAR-T疗法的有效性，而ADC则是在生物药时代对于传统化疗的最好狙击。TCE已然从血液瘤以及自免领域扩展到实体瘤，而ADC则随着双/多靶点以及双/多载荷等新技术的应用而进化到下一范式。在JPM大会上，艾伯维研发副总裁兼首席科学官表示公司将继续在全球范围内寻找ADC以及血液瘤的合适管线。而在亮相2026JPM的中国公司中，德琪医药则是少有的在ADC以及TCE领域均有布局的Biotech。 CLDN18.2的持续推进与ADC平台终见真章商业化与临床开发并进的德琪医药。德琪医药目前有一款处于商业化阶段的药品——塞利尼索，在亚太十个国家和地区获批了R/R MM、MM（≥1 线既往治疗）以及R/R DLBCL三个适应症，2025年H1营收为5320万元，相较于2024年同期降低约12%，环比增长超过70%。潜在BIC的ATG-022。临床项目最受关注的莫过于在低表达领域有潜在BIC的靶向CLDN18.2的ADC管线ATG-022。据德琪医药研发日的最新临床数据，ATG-022在CLDN18.2高表达胃癌患者中，2.4mg/kg的高剂量组展现了40%的ORR以及90%的DCR；1.8mg/kg的低剂量组展现了40%的ORR以及86.7%的DCR。在2026JPM上公布的最新数据显示在1.8mg/kg组中，随着观察时间的延长ORR从40%进一步提升至46.7%。最亮眼的数据是在低表达以及超低表达患者（IHC 2≤20%）中展现了28.6%的ORR以及52.4%的DCR。与此对应的是，同靶点ADC的其他管线在该部分患者中几乎没有临床获益。安全性上，1.8mg/kg组中≥3级TEAE仅为25.8%，≥3级TRAE仅为16.1%。 JPM首发Non‑GI肿瘤临床最新数据。在2026JPM上，德琪医药公布了ATG-022在胃癌之外泛肿瘤中的最新临床结果，在9例可评估的患者中实现了22.2%的ORR以及88.9%的DCR。 ATG-022在泛肿瘤的临床疗效处于什么水准？作为同靶点的ADC管线，信达生物旗下的IBI343在胰腺导管腺癌（PDAC）上的临床结果已经于2024年ESMO上公布，在CLDN18.2阳性患者中展现了32.6%的ORR（cORR为23.3%）以及81.4%的cDCR，随后于2025年ASCO公布的更新数据显示在6mg/kg队列中，cORR为22.7%，DCR为81.8%。而恒瑞旗下的SHR‑A1904 虽然在2021年就注册了临床但是至今未有明确的数据读出。综合目前已有的数据，ATG-022在Non‑GI肿瘤上相较于临床推进顺利的IBI343有所不及，但是与恒瑞的SHR‑A1904等登记临床却没有最终读出结果的管线相比在疗效上或具有潜在优势。当然，当下患者数量太少统计数据具有较大的不确定性。临床进度和疗效同样重要。对于ATG-022，纵观整个2025年德琪医药仅新开了一个临床，联合帕博利珠单抗联合/不联合化疗治疗Claudin 18.2阳性、HER2阴性、不可切除或转移性胃癌或胃食管结合部腺癌患者的Ib/II期研究。虽然当下ATG-022临床研究已经覆盖了胃癌1线、2线以及3线疗法，并开展了一揽子Non-GI肿瘤临床计划，但是当竞争对手都已经进入临床III期且与MNC达成全球合作之时，德琪医药的在该核心管线上的临床推进相较而言不尽如人意。下一代双抗ADC。ATG-022之外德琪医药在PD-L1 ADC展露头角的ADC+IO领域给出的答案是一款B7H3/PD-L1双靶点ADC管线，ATG-025。临床前数据显示ATG-025相较于但单靶点ADC展现出更强的疗效，并在实现毒素载荷肿瘤杀伤的同时激活肿瘤免疫。这是一个非常好的靶点组合，结合ATG-022在胃癌领域的优秀表现，ATG-025有望成为ADC+IO的潜在BIC。问题依旧是进度，2027年Q1提交IND。参考德琪医药在2025年年中业绩会上表示将在2025年Q4提交旗下第一款TCE，ATG-201 (CD19 x CD3)，的IND申请已经miss到2026年Q1。希望能在2027年Q1如期见到ATG-025的IND申请。 ADC之外，德琪医药All in TCE 公司在ADC以及CD73之外储备管线最多的领域便是TCE，而公司宣传了许久的具有遮蔽肽效应且拥有CD3自主自主知识产权的TCE平台终于要在近期提交第一个IND申请，来自旗下的ATG-201 (CD19 x CD3)。ATG-201之外，公司在TCE领域还储备了一众处于pre-clinical的管线，包括ATG-106（CDH6 x CD3）、ATG-112（ALPPL2 x CD3）以及ATG-110（LY6G6D x CD3）。德琪医药的TCE技术平台AnTenGager™ 通过诱导疾病相关抗原（DAA）依赖的T细胞结合和激活，在实现较强的活性的同时降低发生CRS的风险。与此同时，可实现与DAA（包括表达水平较低的DAA）的二价结合，利用长度优化过的连接子将一个CD3单链抗体（scFv）结合至TAA抗体铰链区，这让起初被Fab抗体臂掩盖的CD3结合域仅在DAA交联条件下暴露，进而实现T细胞的条件性激活。 ATG-201临床前数据优异。基于德琪医药的遮蔽肽技术，在靶细胞缺乏DAA时其结合相对较少，而在存在DAA时又能以更低的浓度实现更高的细胞杀伤效果。而在TCE领域最具风险的安全性问题CRS上，在临床前数据中ATG-201相较于第一代TCE诱导更低的T细胞耗竭。单次给药即可在CD34人源化小鼠中将B细胞进行完全且深度清除，治疗后第14天，在血液、骨髓或脾脏中均检测不到B细胞。与Benchmark 4相比，ATG-201诱导的IL-6和TNF-α释放显著更低。 FIC的实体瘤TCE，ATG-106（CDH6 x CD3）。CDH6在正常组织（如脑、肾）中表达有限，而在70%-80%的卵巢癌、肾癌，以及部分胆管癌、胃癌中显著高表达。作为实体瘤的新兴靶点之一，目前在ADC领域已经有第一三共以及先声药业的两条管线处于临床阶段，其中第一三共的R-Dxd已经处于III期临床，全球进度领先。目前尚无该靶点的TCE在研。实体瘤TCE的研发难度在于抗原的异质性、实体瘤的物理屏障以及肿瘤微环境。目前实体瘤TCE领域进展最快的是已经在2024年获得FDA批准的tarlatamab，用于ES‑SCLC（铂化疗后进展）的治疗，但是依旧带着CRS的毒性标签。而主流的应对实体瘤的方式有剂量递增、条件激活以及延长半衰期，而上述三者对于TCE平台将是巨大的考验。 ATG-106也将在2027年Q1提交IND，期待德琪医药TCE平台在真实世界的临床数据。最后还是需要强调一下，临床进度和临床疗效一样重要。与此同时在资本市场，是否与MNC有管线合作（MNC严选）已经成为Biotech的试金石。当药明生物2025年新签订单中超过60%分子来自ADC和双多抗，当艾伯维在2026JPM公开宣称将继续在ADC以及血液瘤领域寻找合适的合作标的时，作为肿瘤以及部分自免治疗的基石性产品，生物医药行业未来最大的市场依旧会是双多抗以及ADC。 For future 更多创新药内容尽在辰小飞的log~ 欢迎添加Murphy微信，备注公司/姓名。Base上海，欢迎线下交流。

抗体药物偶联物细胞疗法免疫疗法临床3期临床2期

2026-01-16

·PRNewswire

Antengene Presents at JPM: Strong Clinical Data Update and Strategic Focus on Next-Generation ADCs and TCEs

SHANGHAI and HONG KONG, Jan. 15, 2026 /PRNewswire/ -- Antengene Corporation Limited ( " Antengene ", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, announced that it recently presented at the 44th Annual J.P. Morgan Healthcare Conference held in San Francisco. At the conference, Antengene shared the latest data and clinical development plans for its core clinical asset, ATG-022 (a CLDN18.2 antibody-drug conjugate [ADC]), as well as R&D progress on ATG-125 (a B7-H3 x PD-L1 bispecific ADC), its steric hindrance masking AnTenGager™ T cell engager (TCE) platform, and other key preclinical programs. 1 . Core Clinical Program: ATG-022 Latest data from the Phase I/II CLINCH study: As of December 25, 2025, among patients with moderate to high CLDN18.2 expression (IHC 2+ > 20%) in the 2.4 mg/kg dose cohort, the objective response rate (ORR) was 40% (12/30) and the disease control rate (DCR) was 90% (27/30), with a median progression-free survival (mPFS) of 5.09 months and a median overall survival (mOS) of 14.72 months. In the 1.8 mg/kg dose cohort, the ORR was 46.7% (14/30), the DCR was 86.7% (26/30), the mPFS was 6.97 months, and the mOS has not yet been reached. Among patients with low/ultra-low CLDN18.2 expression (IHC 2+ ≤ 20%) treated at the efficacious dose range of 1.8-2.4 mg/kg, the ORR was 28.6% (6/21). In addition, one patient in each of the three dose groups achieved a complete response (CR). These results demonstrated the potent anti-tumor activity of ATG-022 across all levels of CLDN18.2 expression. Promising frontline combination potential: Compared with the data presented at the Company's R&D Day in November last year, the 1.8 mg/kg dose group demonstrated a further improvement in ORR and a meaningful prolongation in mPFS, while maintaining a favorable safety profile. The incidence of Grade 3 or higher treatment-related adverse events (TRAEs) was only 19.4%. This differentiated safety profile positions ATG-022 as a potentially best-in-class ADC in terms of safety, with the potential to be combined with checkpoint inhibitors (CPIs) and chemotherapy to transform the current frontline standard-of-care regimen. First Disclosure of Positive Clinical Signals of ATG-022 in Non-Gastrointestinal Tumors: As of January 6, 2025, among 9 efficacy evaluable patients, the ORR was 22.2% (2/9), and DCR was 88.9% (8/9). These data suggest that ATG-022 may have the potential to treat CLDN18.2-positive non-gastrointestinal tumors, which could expand the treatable patient population beyond gastrointestinal cancers. The efficacy observed to date also supports further exploration of CLDN18.2 as a pan-tumor therapeutic target. Advancing clinical development across 1L to 3L gastric cancer: Antengene is currently conducting the Phase I/II CLINCH study and the Phase Ib/II CLINCH-2 study of ATG-022 in Mainland of China and Australia. The Company continues to advance the clinical development of ATG-022 across different lines of gastric cancer treatment, including first-line therapy in combination with checkpoint inhibitors (CPIs) and chemotherapy (CAPOX/FOLFOX); second-line therapy in combination with CPIs; and third-line therapy as monotherapy, covering patients with varying levels of CLDN18.2 expression. In addition, the CLINCH study of ATG-022 includes a basket trial cohort evaluating multiple tumor types, with the majority of patients continuing to receive treatment. 2. Next-Generation ADCs and Proprietary TCEs ATG-125 (B7-H3 × PD-L1 bispecific ADC): ATG-125 is an "IO+ADC " dual-function molecule targeting B7-H3 and PD-L1, integrating the direct cytotoxic activity of an ADC with the durable immune activation of immuno-oncology (IO) therapies. By simultaneously blocking B7-H3- and PD-L1-mediated immunosuppressive signaling, ATG-125 effectively activates T cells and induces immunological memory. Preclinical studies demonstrate that the bispecific ADC delivers superior in vivo efficacy compared with single-target B7-H3-ADC or PD-L1-ADC approaches. The Company plans to submit an IND for ATG-125 in Q1 2027. TCE platform with steric hindrance masking technology: AnTenGager™ is Antengene's proprietary, second-generation T cell engager (TCE) platform featuring "2+1" bivalent binding for low-expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform's broad applicability across autoimmune diseases, solid tumors and hematological malignancies indications. Leveraging this platform, Antengene has discovered multiple investigational programs: ATG-201 (CD19 x CD3 TCE): ATG-201 is a novel "2+1" CD19-targeted T-cell engager developed on the AnTenGager™ TCE platform for the treatment of B cell related autoimmune diseases. Preclinical data presented at the 2025 American College of Rheumatology (ACR) Annual Meeting showed that in non-human primate (NHP) models, the monkey surrogate of ATG-201 achieved deep and durable depletion of naïve B cells with a favorable safety profile, characterized by only a very mild and transient increase in cytokine levels. The IND-enabling study of ATG-201 has been completed and the IND-submission is under preparation. ATG-106 (CDH6 x CD3 TCE): A global first-in-class CDH6 x CD3 targeted TCE being developed for the treatment of ovarian cancer and kidney cancer. The Company plans to submit an IND for ATG-106 in the first half of 2027. ATG-112 (ALPPL2 x CD3 TCE): A global first-in-class ALPPL2 x CD3 targeted TCE being developed for the treatment of gynecologic tumor, non-small cell lung cancer, and pancreatic ductal adenocarcinoma. The Company has nominated a preclinical candidate (PCC) in January 2026. Additional TCE programs for solid tumors: Antengene plans to submit an IND for ATG-110 (LY6G6D × CD3 TCE) in the first half of 2027 for the treatment of microsatellite-stable colorectal cancer. In addition, ATG-115 (an undisclosed bispecific antibody) and two undisclosed trispecific antibody programs are currently in preclinical development. 3. Innovative Treatment for Autoimmune Diseases: Globally First-in-Class ATG-207 ATG-207 is a globally first-in-class dual-function biologic being developed for the treatment of T cell–mediated autoimmune diseases. The Company plans to present the preclinical data for ATG-207 for the first time at an international scientific conference in 2026. About Antengene Antengene Corporation Limited (" Antengene", SEHK: 6996.HK) is a global, R&D-driven, commercial-stage biotech company focused on developing first-in-class/best-in-class therapeutics for diseases with significant unmet medical needs. Its pipeline spans from preclinical to commercial stages and includes several in-house discovered programs, including ATG-022 (CLDN18.2 ADC) , ATG-037 (oral CD73 inhibitor) , ATG-101 (PD-L1 × 4-1BB bispecific antibody) , ATG-031 (CD24-targeting macrophage activator) , and ATG-042 (oral PRMT5-MTA inhibitor). Antengene has also developed AnTenGager™, a proprietary T cell engager 2.0 platform featuring "2+1" bivalent binding for low-expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform's broad applicability across autoimmune disease, solid tumors and hematological malignancies indications. To date, Antengene has obtained 32 investigational new drug (IND) approvals in the U.S. and Asia, and submitted new drug applications (NDAs) in 11 Asia Pacific markets. Its lead commercial asset, XPOVIO® (selinexor) , is approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia, and has been included in the national insurance schemes in five of these markets (Mainland of China, Taiwan China, Australia, South Korea and Singapore). Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2024, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] BD Contacts: Ariel Guo E-mail: [email protected] SOURCE Antengene Corporation Limited 21% more press release views with Request a Demo

临床结果上市批准

100 项与 ATG-022 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
转移性胃食管结合部腺癌	临床2期	中国	德琪医药有限公司	2026-03-01
CLDN18.2阳性胃食管交界处腺癌	临床2期	中国	德琪（杭州）生物有限公司	2025-12-09
CLDN18.2阳性胃癌	临床2期	中国	德琪（杭州）生物有限公司	2025-12-09
转移性胃癌	临床2期	中国	德琪医药有限公司	2024-03-20
转移性胃癌	临床2期	澳大利亚	德琪医药有限公司	2024-03-20
晚期恶性实体瘤	临床1期	澳大利亚	德琪（杭州）生物有限公司	2023-03-01
CLDN18.2阳性实体瘤	临床1期	澳大利亚	德琪（杭州）生物有限公司	2023-03-01
胃癌	临床前	美国	德琪（杭州）生物有限公司	2023-05-22
胰腺癌	临床前	美国	德琪（杭州）生物有限公司	2023-05-16

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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


NCT05718895 (CLINCH, Company_Website) 人工标引	临床1/2期	肿瘤 CLDN18.2 Positive	-	ATG-022 2.4mg/kg (CLDN18.2中高表达患者 (IHC 2+ > 20%))	夢窪願築膚醖積選顧願(願鬱鹹獵淵艱繭淵襯鬱) = 艱蓋廠網鑰齋繭醖憲蓋衊顧選膚廠觸顧範夢襯 (願膚襯憲廠窪築膚範選 ) 更多	积极	2026-01-06
				ATG-022 1.8mg/kg (CLDN18.2中高表达患者 (IHC 2+ > 20%))	夢窪願築膚醖積選顧願(願鬱鹹獵淵艱繭淵襯鬱) = 糧觸築憲窪積襯壓糧壓衊顧選膚廠觸顧範夢襯 (願膚襯憲廠窪築膚範選 ) 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%))	窪衊膚顧壓膚鑰夢艱齋(繭鑰構艱壓醖觸築艱蓋) = 醖選壓衊鹽餘鹽壓獵餘觸餘齋範積簾願襯範願 (選獵網蓋蓋壓鹹簾範願 ) 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%))	窪衊膚顧壓膚鑰夢艱齋(繭鑰構艱壓醖觸築艱蓋) = 窪壓鏇襯鏇餘膚廠齋鑰觸餘齋範積簾願襯範願 (選獵網蓋蓋壓鹹簾範願 ) 更多
NCT05718895 (CLINCH, Corporate Publications \| Company_Website) 人工标引	临床1/2期	CLDN18.2阳性胃食管交界处腺癌 \| CLDN18.2阳性胃腺癌 CLDN18.2 Positive \| HER2 Negative	81	ATG-022 2.4 mg/kg (CLDN18.2 Moderate-to-high expression (IHC 2+ > 20%))	廠選鹹獵廠鏇襯獵構構(壓鏇選積構願觸糧繭繭) = 簾齋衊繭繭蓋選醖築獵鹹簾窪選鹽顧積鹽願鑰 (鹽糧蓋餘壓衊壓衊觸鏇 ) 更多	积极	2025-08-19
				ATG-022 1.8 mg/kgATG-022 1.8 mg/kg (CLDN18.2 Moderate-to-high expression (IHC 2+ > 20%))	廠選鹹獵廠鏇襯獵構構(壓鏇選積構願觸糧繭繭) = 觸膚淵網願願鏇構夢簾鹹簾窪選鹽顧積鹽願鑰 (鹽糧蓋餘壓衊壓衊觸鏇 ) 更多
NCT05718895 (CLINCH, NEWS) 人工标引	临床1期	CLDN18.2阳性实体瘤 CLDN18.2 Positive	-	ATG-022 (CLDN18.2 IHC 2+ ≥ 20%)	餘遞鹽選獵廠選夢襯膚(遞壓遞齋願衊衊襯構網) = 衊餘齋鬱構構醖醖憲選願構鹹蓋願選選餘獵構 (艱繭憲積積顧窪築蓋範 ) 更多	积极	2025-05-20
				ATG-022 (CLDN18.2 IHC 2+ < 20%)	餘遞鹽選獵廠選夢襯膚(遞壓遞齋願衊衊襯構網) = 齋鏇鑰艱淵餘獵觸膚糧願構鹹蓋願選選餘獵構 (艱繭憲積積顧窪築蓋範 ) 更多
NCT05718895 (CLINCH, ASCO_GI2025) 人工标引	临床1期	晚期恶性实体瘤 \| 胃癌 CLDN18.2 Positive	37	ATG-022 (dose escalation phase)	積網夢鏇繭構壓遞顧範(觸齋艱鏇築齋鏇簾衊範) = in dose escalation, 1 DLT of grade 3 nausea found at 3 mg/kg among 6 pts 遞艱繭鏇壓構繭顧網衊 (壓築窪憲蓋憲顧夢壓築 ) 更多	积极	2025-01-23
				ATG-022 (dose expansion phase)
NEWS 人工标引	临床2期	胃癌 CLDN6 Positive	12	ATG-022	艱鏇醖網鹽鏇構淵艱醖(齋齋範窪鏇廠選觸範構) = 範艱網遞願築廠範鏇糧獵夢觸築製衊蓋鬱鑰構 (糧簾壓夢窪餘艱構鏇選 ) 更多	积极	2024-08-23
				ATG-022 (Claudin18.2中高表达)	艱鏇醖網鹽鏇構淵艱醖(齋齋範窪鏇廠選觸範構) = 醖鹹艱醖衊齋窪願餘顧獵夢觸築製衊蓋鬱鑰構 (糧簾壓夢窪餘艱構鏇選 ) 更多
NCT05718895 (CLINCH, ASCO2024) 人工标引	临床1期	实体瘤 CLDN18.2 Positive	10	ATG-022 0.9 mg/kg	積選齋鏇蓋簾襯鹽糧齋(齋齋醖網網廠壓餘鏇願) = 繭範襯衊範選窪觸窪觸願鹽蓋鏇襯衊網鏇獵壓 (鹹選鑰製鑰艱艱醖築網 )	-	2024-05-24
				ATG-022 1.8 mg/kg	積選齋鏇蓋簾襯鹽糧齋(齋齋醖網網廠壓餘鏇願) = 築製鹽觸鑰襯顧選繭鏇願鹽蓋鏇襯衊網鏇獵壓 (鹹選鑰製鑰艱艱醖築網 ) 更多