佐妥昔单抗(Zolbetuximab) - 药物靶点：CLDN18.2_在研适应症：晚期胃食管交界处腺癌，CLDN18.2阳性胃食管交界处腺癌，CLDN18.2阳性胃腺癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Claudiximab、Zolbetuximab-CLZB、佐贝妥昔单抗

+ [9]

靶点

CLDN18.2

作用方式

抑制剂

作用机制

CLDN18.2抑制剂(Claudin 18.2蛋白抑制剂)、ADCC(抗体依赖的细胞毒作用)、补体依赖的细胞毒性作用

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病

在研适应症

晚期胃食管交界处腺癌CLDN18.2阳性胃食管交界处腺癌CLDN18.2阳性胃腺癌+ [9]

非在研适应症

腺癌CLDN18.2阳性胃肠道肿瘤食管癌+ [1]

原研机构

Ganymed Pharmaceuticals AG

在研机构

Astellas Pharma Global Development, Inc.

安斯泰来制药（中国）有限公司Astellas Pharma Europe BV

+ [5]

非在研机构

Ganymed Pharmaceuticals AG

权益机构

上药控股有限公司

Ganymed Pharmaceuticals AG

Astellas Pharma, Inc.

最高研发阶段批准上市

首次获批日期

日本 (2024-03-26),

CLDN18.2阳性胃癌

最高研发阶段(中国)批准上市

特殊审评加速批准 (美国)、孤儿药 (韩国)、孤儿药 (澳大利亚)、优先审评 (美国)

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结构/序列

Sequence Code 431594752L

来源: *****

Sequence Code 524309292H

来源: *****

关联

24

项与佐妥昔单抗相关的临床试验

JPRN-jRCT2031260183

/ Recruiting临床2期

A Phase II Study of Zolbetuximab, Trastuzumab, and CapeOX, with Pembrolizumab Based on PD-L1 Expression, in Patients with HER2-positive and CLDN18.2-positive Advanced Gastric or Gastroesophageal Junction Cancer (ZAP-HETERO study)

开始日期2026-06-01

申办/合作机构-

JPRN-jRCT1031250843

/ RecruitingN/A

A multifaceted analysis for the elucidation of the pathophysiology of hypoalbuminemia occurring during zolbetuximab + chemotherapy

开始日期2026-03-25

申办/合作机构

Astellas Pharma, Inc.

JPRN-jRCTs051250148

/ Recruiting临床2期

OGSG2501:A phase II trial of Zolbetuximab combination with CAPOX or FOLFOX for HER2-negative and Claudin 18.2-positive gastric cancer early relapsed during or after adjuvant chemotherapy(Z-FIGHTERS Study)

开始日期2025-10-31

申办/合作机构-

100 项与佐妥昔单抗相关的临床结果

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100 项与佐妥昔单抗相关的转化医学

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100 项与佐妥昔单抗相关的专利（医药）

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168

项与佐妥昔单抗相关的文献（医药）

2026-06-05·JAPANESE JOURNAL OF CLINICAL ONCOLOGY

Zolbetuximab-based chemotherapy in CLDN18.2-positive gastric cancer: real-world tumor response and early albumin kinetics

Article

作者: Yamamoto, Kei ; Kudo, Toshihiro ; Kobayashi, Shogo ; Gotoh, Kunihito ; Matsuura, Norihiro ; Fukuda, Yasunari ; Kubo, Masahiko ; Kagawa, Yoshinori ; Sueda, Toshinori ; Sakano, Yoshihiro ; Kanemura, Takashi ; Kitakaze, Masatoshi ; Yamamoto, Kazuyoshi ; Mori, Ryota ; Yanagimoto, Yoshitomo ; Miyo, Masaaki ; Sugase, Takahito ; Miyata, Hiroshi ; Ushimaru, Yuki ; Sakai, Daisuke ; Komatsu, Hisateru ; Masuike, Yasunori

Abstract:

Background:

Zolbetuximab combined with fluoropyrimidine–oxaliplatin chemotherapy has demonstrated clinical benefit in CLDN18.2-positive, HER2-negative advanced gastric and gastroesophageal junction adenocarcinoma (GC/GEJC). In clinical practice, however, gastrointestinal toxicity and serum albumin decline are frequently encountered during treatment, and the relationship between early albumin kinetics and antitumor efficacy remains unclear.

Methods:

We conducted a single-center retrospective exploratory study of patients with unresectable or recurrent CLDN18.2-positive GC/GEJC treated with zolbetuximab-based chemotherapy between July 2024 and August 2025. Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in patients with measurable disease. The objective response rate (ORR) and early tumor shrinkage (ETS ≥20%) were assessed. Serum albumin kinetics were analyzed using baseline albumin, landmark nadir albumin measured at or immediately before the first radiological evaluation, and relative change in albumin from baseline (ΔAlb). Associations between albumin metrics and tumor response were explored using exploratory analyses, including continuous-variable modeling. Relative dose intensity and chemotherapy backbone (CAPOX vs FOLFOX) were also descriptively examined.

Results:

Among 38 eligible patients, 24 had measurable disease and were evaluable for RECIST-based response. Partial response was observed in 18 patients, yielding an ORR of 75.0% (95% CI, 55.1–88.0). Early tumor shrinkage ≥20% was achieved in a proportion of evaluable cases. Baseline serum albumin showed a moderate positive correlation with landmark nadir albumin (Spearman’s ρ = 0.35, P = .030) and with ΔAlb (ρ = 0.52, P = .0007), indicating that patients with higher baseline albumin tended to experience greater absolute albumin decline. Neither landmark nadir albumin nor ΔAlb was significantly associated with the ORR or ETS. Early reductions in serum albumin were frequently observed during initial treatment cycles but did not correspond to impaired tumor response.

Conclusions:

In this real-world exploratory cohort, zolbetuximab-based chemotherapy achieved objective tumor responses consistent with prior clinical trials. Early serum albumin decline was not associated with inferior tumor response. These findings suggest that early albumin decline should not be interpreted as a surrogate marker of treatment failure or reduced antitumor efficacy but rather as a treatment-related physiological change. Prospective studies are warranted to clarify the clinical implications of albumin dynamics and optimize supportive care during anti-CLDN18.2 therapy.

2026-06-01·EUROPEAN JOURNAL OF CANCER

Gastric cancer: French intergroup clinical practice guidelines for diagnosis, staging, treatment and follow-up (TNCD, SNFGE, FFCD, UNICANCER, GERCOR, SFCD, SFED, AFEF, SFRO, SFP, SFR, ACHBPT, RENAPE, SNFCP)

Review

作者: Ducreux, Michel ; Abdelghani, Meher Ben ; Dubreuil, Olivier ; Renaud, Florence ; Jary, Marine ; Palle, Juliette ; Zaanan, Aziz ; Gagniere, Johan ; Mariani, Antoine ; Buecher, Bruno ; Barret, Maximilien ; Durand-Labrunie, Jerome ; Chapelle, Nicolas ; Palmieri, Lola-Jade ; Bouché, Olivier ; Fares, Nadim

INTRODUCTION:

The updated edition of the French intergroup guidelines for the management of patients with gastric and gastroesophageal junction adenocarcinoma is a collaborative work of several national medical societies, and available on the website of the French Society of Gastroenterology (SNFGE) (www.tncd.org).

METHODS:

The recommendations are graded into three categories (A, B, and C), based on the level of scientific evidence published until January 2026.

RESULTS:

Initial staging and risk assessment should include physical evaluation, endoscopy and computed tomography-scan of the thorax, abdomen, and pelvis. For resectable disease, endoscopic ultrasonography can be used for T and N staging, while laparoscopic exploration may be performed to exclude occult peritoneal metastases, especially for cT3/cT4 and poorly cohesive tumors. Endoscopic or surgical resection alone is appropriate for very early cT1N0 tumors. For locally advanced disease ≥cT2 and/or cN + , the perioperative FLOT chemotherapy is recommended as the standard of care. Recently, the addition of durvalumab to perioperative FLOT followed by durvalumab for 10 months as maintenance therapy was associated with a significant improvement of survival. For metastatic disease, the first-line chemotherapy is based on platinum-fluoropyrimidine combination. The addition of targeted therapy and/or immunotherapy to doublet chemotherapy depends on the tumor biomarker profile, including HER2 (trastuzumab), claudin18.2 (zolbetuximab), PD-L1 and dMMR/MSI phenotype (anti-PD1 monoclonal antibodies). The addition of docetaxel, based on the triplet TFOX regimen may be considered for selected patients with biomarker-negative tumors. Resection of primary tumor and metastases cannot be recommended but may be considered on an individual basis in highly selected patients with oligometastatic disease who respond to systemic treatment. Various drugs are indicated beyond first-line of treatment, including trastuzumab-deruxtecan for HER2-positive tumors.

CONCLUSION:

These national guidelines on gastric cancer are intended to facilitate decision-making in daily clinical practice. These recommendations are subject to ongoing review. Each individual case should be discussed within a multidisciplinary team.

2026-06-01·SURGERY TODAY

Spatial discordance of claudin18.2 in gastric cancer: clinical implications for patient selection in Zolbetuximab therapy

Article

作者: Maruyama, Suguru ; Mochizuki, Kunio ; Amemiya, Hidetake ; Takiguchi, Koichi ; Ozawa, Takaomi ; Saito, Ryo ; Kawaida, Hiromichi ; Shoda, Katsutoshi ; Kawaguchi, Yoshihiko ; Tanaka, Hiroto ; Izumo, Wataru ; Ichikawa, Daisuke ; Matsuoka, Koichi ; Higuchi, Yudai ; Mizukami, Akihito ; Furuya, Shinji ; Shiraishi, Kensuke ; Nakayama, Takashi

578

项与佐妥昔单抗相关的新闻（医药）

2026-06-12

·上海丰能数字健康技术研究院

【文献解读120】靶向肿瘤驱动基因的胃癌治疗研究进展

——基于《浙江大学学报（医学版）》综述文献的深度剖析 | 吴世英，徐平龙，张飞团队导语胃癌作为全球第五大常见癌症，其高发病率和死亡率，尤其在我国，构成了严峻的公共卫生挑战。传统放化疗虽为基础手段，但其缺乏特异性与显著的毒副作用促使研究者寻求更精准的治疗策略。肿瘤驱动基因的发现与鉴定，开启了胃癌靶向治疗的新时代。从首个靶向药物曲妥珠单抗的获批，到针对VEGF、FGFR2、CLDN18.2等新靶点的药物进入临床试验，靶向治疗正逐步改变胃癌的治疗格局。本文基于吴世英等学者在《浙江大学学报（医学版）》发表的综述，系统梳理胃癌关键驱动基因及其靶向治疗的最新进展，旨在为临床决策与新药研发提供参考。一、 HER2：确立一线地位与耐药突围1.1 生物学基础与临床意义 HER2是EGFR家族的关键成员，其过表达或扩增见于约20%的胃癌患者。不同于其他家族成员，HER2无固定配体，需通过异源二聚化激活，持续驱动Ras/MAPK和PI3K/Akt等促癌通路。重要的是，HER2还能抑制肿瘤免疫中的关键核酸识别信号，促进免疫逃逸。因此，靶向HER2不仅直接抑制肿瘤增殖，还可能改善肿瘤微环境。1.2 临床实践与药物迭代曲妥珠单抗联合化疗作为一线方案，其里程碑式的ToGA试验证实，可将HER2阳性晚期胃癌患者的中位总生存期从11.1个月延长至13.8个月，确立了其标准地位。针对围手术期患者，曲妥珠单抗联合方案也显示出提高病理完全缓解率的潜力。面对耐药与异质性挑战，新型药物不断涌现。德喜曲妥珠单抗（T-DXd）作为一种抗体药物偶联物（ADC），在二线治疗中展现出惊人的疗效，总反应率可达51%，其“旁观者效应”能杀伤周边HER2阴性细胞。小分子抑制剂如图卡替尼、高亲和力抗体如马吉妥昔单抗等也在临床试验中积极探索。研究/药物治疗线数关键疗效数据意义/阶段 ToGA (曲妥珠单抗) 一线 OS: 13.8 vs 11.1个月确立HER2阳性胃癌一线标准 NEOHX (曲妥珠单抗) 围手术期 pCR率: 9.6%；18个月DFS率>70% 显示新辅助治疗潜力 DESTINY-Gastric01 (T-DXd) 二线及以上 ORR: 51% vs 14% (化疗) ADC药物突破，Ⅱ期关键研究 (NCT04499924) (图卡替尼) 二线评估联合方案疗效小分子TKI的联合探索，Ⅱ/Ⅲ期进行中二、 VEGF/VEGFR：抗血管生成的二线基石与一线探索2.1 作用机制与药物现状 VEGF通过促进血管通透性增加、内皮细胞迁移和增殖，为肿瘤生长提供营养，是抗血管生成治疗的核心靶点。雷莫芦单抗作为VEGFR2单抗，单药或联合紫杉醇在二线治疗中已确立地位。RAINBOW试验证实，联合治疗能显著延长患者总生存期（OS）。国内小分子药物阿帕替尼也在临床试验中显示出对晚期胃癌患者的生存获益。2.2 一线治疗的困境与未来方向值得关注的是，抗血管生成药物在未经选择的晚期胃癌一线治疗中表现不佳，如RAINFALL研究中雷莫芦单抗联合化疗未达到主要终点。这提示该疗法可能仅适用于特定人群。然而，在围手术期（如FLOT联合雷莫芦单抗的RAMSES/FLOT7研究）的探索中，观察到对较大肿瘤患者可能有益，提示其应用场景或需精准筛选。三、 FGFR2：从基因变异到精准抗体 FGFR2基因变异（主要为扩增，约占71.7%）在胃癌中发生率为2%-9%，其过表达与肿瘤侵袭性强、预后差相关。靶向FGFR2的单抗贝马利珠单抗在Ⅱ期FIGHT研究中表现亮眼。对于FGFR2b高表达患者，联合化疗相比单纯化疗，将中位总生存期从11.1个月大幅提升至25.4个月，且疗效与靶标表达水平呈正相关，展现了生物标志物指导下的精准治疗前景。口服FGFR1-3抑制剂德拉赞替尼的相关联合治疗研究也在进行中。四、 CLDN18.2：新兴靶点的崛起 CLDN18.2是一种在正常胃黏膜中隐蔽，但在癌变后暴露的细胞表面蛋白，为治疗提供了理想的靶点。佐妥昔单抗是其代表性单抗。Ⅱ期FAST研究显示，联合化疗可显著延长CLDN18.2阳性胃癌患者的无进展生存期和总生存期，且疗效与表达水平相关。目前，两项关键的Ⅲ期试验（SPOTLIGHT和GLOW）已取得积极结果，有望推动其成为新的标准疗法。此外，靶向CLDN18.2的CAR-T细胞疗法（如CT041）和双特异性抗体也显示出早期活性，为该靶点的治疗开辟了更多可能。五、其他驱动基因：MET、ARID1A、KRAS与NTRK MET扩增/过表达与胃癌不良预后相关，但靶向其通路的单抗（如奥那妥组单抗、利妥木单抗）在大型Ⅲ期试验中均告失败，挑战巨大。染色质重塑蛋白ARID1A的突变在EBV阳性及MSI型胃癌中高频出现，其缺失可能导致对DNA损伤修复药物（如PARP抑制剂）或mTOR抑制剂敏感，相关策略尚处临床前阶段。KRAS突变在胃癌中虽不如肺癌常见，但仍是难治靶点，目前主要策略是靶向其下游通路。NTRK融合在胃癌中极为罕见（1%），但针对该靶点的广谱TRK抑制剂在其他癌种中的成功，仍为这部分极少数患者带来了希望。驱动基因胃癌中变异频率主要靶向策略临床研究现状 MET ~18%阳性；扩增见于弥漫型 HGF/MET单抗，小分子TKI Ⅲ期临床试验失败，策略遇冷 ARID1A 8%-27%突变（亚型依赖）合成致死（PARP/mTOR/EZH2抑制剂）临床前研究活跃，无胃癌临床试验 KRAS 较低（相比其他癌种）靶向下游RAF/MEK/ERK, PI3K/AKT通路在胃癌中疗效有限，研究深入 NTRK融合极罕见 ( 1%) 泛TRK抑制剂（拉罗替尼、恩曲替尼）个案报道，基于其他癌种获批核心要点总结与展望靶向治疗已改变格局：针对HER2（曲妥珠单抗、T-DXd）和VEGFR2（雷莫芦单抗）的靶向药物已成为晚期胃癌标准治疗的一部分，显著改善了特定患者群体的生存。新兴靶点前景可期： FGFR2（贝马利珠单抗）和CLDN18.2（佐妥昔单抗）在临床试验中展现出超越传统化疗的生存获益，有望成为下一代标准治疗，推动胃癌进入更精细的靶向治疗时代。挑战与机遇并存：胃癌的高度时空异质性、现有靶点的耐药性、以及MET、KRAS等难治靶点的药物开发失败，仍是当前面临的主要挑战。未来方向：① 精准生物标志物筛选是关键，需通过更全面的基因组学、转录组学检测指导用药。② 联合治疗是趋势，将靶向治疗与化疗、免疫治疗、放疗等手段有机结合，发挥协同作用。③ 新药与新策略开发，包括ADC、双特异性抗体、CAR-T细胞疗法等新型疗法，以及针对ARID1A缺陷的合成致死策略。参考文献： [1] SUNG H, et al. CA Cancer J Clin, 2021, 71(3): 209-249. [2] XIA C F, et al. Chin Med J (Engl), 2022, 135(5): 584-590. [3] ALSINA M, et al. Nat Rev Gastroenterol Hepatol, 2023, 20(3): 155-170. [4] DENG N, et al. Gut, 2012, 61(5): 673-684. [6] BASS A J, et al. Nature, 2014, 513(7517): 202-209. [19] OH D Y, et al. Nat Rev Clin Oncol, 2020, 17(1): 33-48. [20] BANG Y J, et al. Lancet, 2010, 376(9742): 687-697. [23] SHITARA K, et al. N Engl J Med, 2020, 382(25): 2419-2430. [43] CATENACCI D V T, et al. J Clin Oncol, 2021, 39(15): 4010. [50] SAHIN U, et al. Ann Oncol, 2021, 32(5): 609-619. [51] SHAH M A, et al. Nat Med, 2023, 29(8): 2133-2141. [52] SHITARA K, et al. Lancet, 2023, 401(10389): 1655-1668. [59] CATENACCI D, et al. Lancet Oncol, 2017, 18(11): 1467-1482. [60] SHAH M A, et al. JAMA Oncol, 2017, 3(5): 620-627. [78] PU X, et al. J Clin Pathol, 2023. DOI:10.1136/jcp-2023-208865. 注：本文基于公开文献内容进行解读与梳理，不构成任何医疗建议。临床决策请参考最新指南并咨询专业医师。

2026-06-12

·达安欣-RAS靶向原料供应商

全球首个！IBI343申报上市——CLDN18.2 ADC即将改写胃癌治疗版图

全球首个！IBI343申报上市——CLDN18.2 ADC即将改写胃癌治疗版图 2026年6月4日，信达生物宣布其自主研发的IBI343——全球首个靶向CLDN18.2的ADC药物——新药上市申请（NDA）获国家药品监督管理局（NMPA）受理，并被纳入优先审评。这一事件具有明确的里程碑意义：全球首个进入监管审查阶段的CLDN18.2 ADC。与此同时，IBI343在胰腺癌领域的布局也在同步推进，让这个分子的想象空间远不止于胃癌。G-HOPE-001：支撑NDA的关键III期数据 IBI343的NDA基于G-HOPE-001 III期临床研究，旨在评估IBI343在CLDN18.2阳性、至少接受过两线治疗的晚期胃或胃食管结合部腺癌患者中的疗效与安全性。该研究达到主要终点，具体数据将在近期学术会议上公布。 IBI343的设计颇具特色：糖基化CLDN18.2特异性抗体 + 拓扑异构酶I抑制剂（exatecan）payload + 可裂解连接子，DAR值约为4。与第一代ADC使用的MMAE（微管抑制剂）payload不同，exatecan作为拓扑异构酶I抑制剂具有更强效的细胞毒性活性和不同的旁观者效应。CLDN18.2赛道三线并进：单抗 vs 双抗 vs ADC CLDN18.2是胃癌领域过去五年最炙手可热的靶点之一，目前形成了三条清晰的竞争路线：路线代表药物现状特点单克隆抗体 Zolbetuximab（安斯泰来）中国已获批联合化疗一线胃癌双特异性抗体 Spevatamig（CLDN18.2/CD47） II期胰腺癌 mOS 14.7月 ADC IBI343（信达） NDA优先审评全球首个CLDN18.2 ADC NDA CLDN18.2在胃癌中的阳性率约为30-50%，而在胰腺癌中阳性率更高，达到50-70%。这为IBI343从胃癌向胰腺癌的跨瘤种扩展提供了强有力的生物学基础。信达已在胰腺癌后线治疗中布局了IBI343的临床研究，如果数据积极，胰腺癌将成为这一分子的第二增长曲线。中国ADC军团在CLDN18.2赛道的全球地位 IBI343的NDA只是中国CLDN18.2 ADC军团的一个缩影。目前在该赛道上，中国药企的布局深度和广度全球无出其右： - 信达生物 IBI343：NDA阶段，exatecan payload - 科济药业 AB011：CLDN18.2 CAR-T + ADC，I期 - 康诺亚 CMG901：CLDN18.2 ADC，I/II期 - 石药集团 SYSA1801：CLDN18.2 ADC，授权Elevation Oncology - 礼新医药 LM-302：CLDN18.2 ADC，授权Turning Point/BMS 在CLDN18.2这个靶点上，中国企业已经从"跟随者"变成了"引领者"。全球范围内，进入关键临床阶段的CLDN18.2 ADC中，中国企业的比例超过70%。这不仅是单一药物层面的领先，更代表了中国在ADC技术平台上的系统性优势。CLDN18.2 ADC vs 单抗：下一代疗法已在路上 Zolbetuximab联合化疗一线治疗CLDN18.2阳性胃癌已在中国获批，但单抗的局限性也显而易见：仅约30-40%的ORR、需联合化疗、无跨瘤种证据。 ADC的优势在于"精确制导+核弹载荷"——抗体部分负责精准定位CLDN18.2阳性细胞，payload则释放强效细胞毒性直接杀伤肿瘤，旁观者效应则进一步扩大杀伤范围。理论上，ADC可以在CLDN18.2表达水平较低的患者中同样产生抗肿瘤活性，这大大扩展了适用人群。如果IBI343顺利获批，CLDN18.2赛道的格局将从"单抗独大"进入"ADC与单抗分治"的新阶段，届时患者将有更精准、更有效的分层治疗选择。关于达安欣上海达安欣生物医药有限公司专注 RAS 通路靶向原料药研发与生产全球首家获 FDA DMF 认证的 Daraxonrasib 原料药企业关注本号，回复「RAS」获取 Daraxonrasib 技术资料

2026-06-12

·allsci.com

PeptiDream’s CLDN18.2 radiopharmaceutical enters first-in-human study in gastric cancer

Japan-based PeptiDream Inc. (Tokyo Stock Exchange: 4587) has announced the first patient dosing in a first-in-human radiopharmaceutical clinical trial of 64Cu-PD-29875, a macrocyclic peptide conjugate targeting Claudin 18.2 (CLDN18.2) in patients with gastric or gastroesophageal junction (GEJ) cancer. The PeptiDream claudin18.2 radiopharmaceutical program is structured as a Phase 0 imaging study, using copper-64 (⁶⁴Cu) labelling to generate PET/CT imaging data on safety, pharmacokinetics, tumor uptake, and dosimetry. The study’s diagnostic data are intended to inform the development of a companion ²²⁵Ac-labeled therapeutic, forming an integrated radiotheranostic pair. Patient enrollment numbers and a projected completion date were not disclosed. Endpoints center on diagnostic performance characterization and dosimetry, with the imaging data expected to support the design of subsequent therapeutic trials. The program received funding from Japan’s Agency for Medical Research and Development (AMED) under its Practical Research for Innovative Cancer Control initiative in 2024. CLDN18.2 is a tight-junction transmembrane protein whose normal expression is tightly restricted to differentiated gastric epithelial cells, where it remains physically inaccessible to circulating agents. In gastric and GEJ cancer specifically, CLDN18.2 expression is retained through metastatic progression, making it relevant across disease stages rather than only at diagnosis. The clinical validation of this target arrived with the 2024 FDA approval of zolbetuximab-clzb (Vyloy), a CLDN18.2-directed monoclonal antibody from Astellas Pharma, in first-line HER2-negative, CLDN18.2-positive gastric/GEJ adenocarcinoma — the first approved therapy directed at this target. PD-29875 is a macrocyclic peptide discovered using PeptiDream’s proprietary Peptide Discovery Platform System (PDPS) technology and further optimized through in vivo imaging and efficacy studies at PDRadiopharma, PeptiDream’s wholly owned subsidiary. In its diagnostic configuration, the peptide is conjugated to ⁶⁴Cu, a positron emitter with a 12.7-hour half-life suited to the timescale of peptide biodistribution and tumor accumulation. The claudin18.2 PET imaging data generated in this Phase 0 study are designed to confirm tumor uptake, establish dosimetry parameters, and identify patients most likely to benefit from the therapeutic counterpart — a ²²⁵Ac-labeled version of the same peptide scaffold delivering targeted alpha-particle radiation. This theranostic strategy mirrors the PSMA paradigm in prostate cancer, where ⁶⁸Ga-PSMA PET imaging and ¹⁷⁷Lu-PSMA-617 (Pluvicto) therapy operate as a diagnostic-therapeutic pair. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

100 项与佐妥昔单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	佐妥昔单抗	-	DB15118

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
晚期胃食管交界处腺癌	加拿大	Astellas Pharma Canada, Inc.	2025-01-09
CLDN18.2阳性胃食管交界处腺癌	英国	Astellas Pharma, Inc.	2024-08-14
CLDN18.2阳性胃腺癌	英国	Astellas Pharma, Inc.	2024-08-14
CLDN18.2阳性胃癌	日本	Astellas Pharma, Inc.	2024-03-26

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
局部晚期胃食管交界处腺癌	临床3期	美国	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	中国	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	日本	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	阿根廷	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	加拿大	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	克罗地亚	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	希腊	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	爱尔兰	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	马来西亚	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	荷兰	Astellas Pharma Global Development, Inc.	2018-11-28

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临床结果

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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


NCT06901531 (LUCERNA, ASCO_GI2026)	临床3期	局部晚期胃食管交界处腺癌 \| PD-L1阳性实体瘤 \| CLDN18.2阳性胃腺癌一线 CLDN18.2-positive \| HER2-negative \| PD-L1-positive	500	Zolbetuximab + pembrolizumab + CAPOX/mFOLFOX6	積鹽簾積廠簾鏇鏇窪遞(選範鑰製淵選餘膚築蓋) = 網鏇構淵顧醖製淵願壓製淵願遞餘鹽鏇餘淵艱 (觸鑰鑰製糧壓齋製顧襯, 24.9 ~ NR)	积极	2026-01-08
				Placebo + pembrolizumab + CAPOX/mFOLFOX6	鬱顧齋襯襯廠糧繭醖範(積餘鹽鑰選選鹽鏇獵鹽) = 鹹製襯網鑰鏇鑰網遞鑰獵窪醖糧襯餘鏇糧齋鑰 (衊窪遞築齋顧蓋鹹夢餘, 43.1 ~ 56.9) 更多
ESMO_ASIA2025	N/A	晚期胃食管交界处腺癌一线	22	Zolbetuximab (Zolb) + chemo	積繭鏇顧願築膚齋廠鏇(壓衊窪獵繭願獵繭獵蓋) = abdominal pain (18%) 蓋鬱構憲網醖鬱顧蓋獵 (觸選齋遞艱網顧鹽獵淵 ) 更多	积极	2025-12-05
ESMO_ASIA2025	N/A	晚期胃癌	17	Zolbetuximab+antiemetic therapy+atypical antipsychotics	壓廠願衊願築憲齋衊願(醖醖醖膚淵鑰構鏇窪構) = 襯鹽夢餘憲餘築積鹽壓鑰窪襯壓遞艱憲願廠膚 (襯製鬱簾鏇鹹製壓衊餘 ) 更多	积极	2025-12-05
NCT03504397 (SPOTLIGHT, ESMO_ASIA2025)	临床3期	CLDN18.2阳性胃食管交界处腺癌 \| CLDN18.2阳性胃腺癌一线 CLDN18.2+ \| HER2−	374	Zolbetuximab plus mFOLFOX6/CAPOX	餘衊築鬱顧繭齋艱淵齋(醖鑰鹹觸網蓋範鬱築觸) = The most common grade ≥3 AEs occurring in ≥20% of patients in zolbetuximab arm were neutropenia (20.7%) and vomiting (20.2%). 範鏇遞遞襯選觸築觸鹹 (餘糧衊蓋鬱壓淵膚艱艱 ) 更多	积极	2025-12-05
				Placebo plus mFOLFOX6/CAPOX
NCT03504397 (SPOTLIGHT \| SPOTLIGHT study, CTgov)	临床3期	-	565	folinic acid+zolbetuximab+oxaliplatin+fluorouracil	壓醖鏇淵憲淵餘糧鏇鑰(鏇獵膚選糧夢繭餘淵製) = 淵鑰淵築齋淵鹹艱鏇選鬱憲窪鹹範餘壓選壓鬱 (獵顧餘醖糧壓築膚蓋簾, 襯網鹹願鹹蓋齋鏇鏇襯 ~ 鏇鬱築夢齋鹹憲鏇襯遞) 更多	-	2025-02-26
NCT03653507 (GLOW, CTgov)	临床3期	局部晚期胃食管交界处腺癌 \| 转移性胃食管结合部腺癌	507	CAPOX+Zolbetuximab (CAPOX+ Zolbetuximab)	簾觸觸廠範鹹鏇鬱製願(簾餘選築顧憲艱衊遞糧) = 壓鏇齋製範構獵簾製範繭鑰夢糧膚餘選簾繭齋 (鏇遞網鹹選積選淵製艱, 築顧觸築艱簾遞製鹹醖 ~ 鬱構蓋顧艱衊築簾淵構) 更多	-	2025-01-27
				Placebo (CAPOX+ Placebo)	簾觸觸廠範鹹鏇鬱製願(簾餘選築顧憲艱衊遞糧) = 鬱獵鑰顧淵蓋衊醖淵願繭鑰夢糧膚餘選簾繭齋 (鏇遞網鹹選積選淵製艱, 艱願蓋糧淵鬱蓋齋鏇築 ~ 鑰餘艱鹹淵糧膚遞製廠) 更多
NCT03653507 (GLOW, NEWS) 人工标引	临床3期	胃癌 \| 胃食管交界处腺癌一线 HER2 Negative \| CLDN18.2 Positive	145	佐妥昔单抗联合CAPOX	觸獵壓夢繭製網膚糧構(積齋範觸願壓簾網憲淵) = 廠淵窪繭襯構膚顧餘獵鬱願鬱艱顧願鹹艱醖獵 (選艱齋繭築構鬱蓋膚構, 6.1 ~ 9.1) 更多	积极	2024-09-28
				安慰剂联合CAPOX	觸獵壓夢繭製網膚糧構(積齋範觸願壓簾網憲淵) = 鏇廠觸範餘襯遞窪獵齋鬱願鬱艱顧願鹹艱醖獵 (選艱齋繭築構鬱蓋膚構, 5.0 ~ 8.0) 更多
NCT03504397 (SPOTLIGHT, NEWS) 人工标引	临床3期	胃食管交界处腺癌一线 CLDN18.2 Positive \| HER2 Negative	61	佐妥昔单抗+mFOLFOX6	構淵壓鬱製壓夢鹽觸蓋(觸顧鹹衊築鬱夢窪繭獵) = 網願淵繭願鹹鏇蓋廠膚鬱範淵遞艱壓壓選壓廠 (廠願憲願鬱顧壓艱淵築, 6.7 ~ 16.7) 更多	积极	2024-09-28
				安慰剂+mFOLFOX6	構淵壓鬱製壓夢鹽觸蓋(觸顧鹹衊築鬱夢窪繭獵) = 鑰觸壓壓鏇鹹構鏇窪構鬱範淵遞艱壓壓選壓廠 (廠願憲願鬱顧壓艱淵築, 6.0 ~ 8.4) 更多
NCT03653507 \| NCT03504397 (SPOTLIGHT \| GLOW, ESMO2024)	临床3期	CLDN18.2阳性胃食管交界处腺癌一线 CLDN18.2+ \| HER2-	1,072	Zolbetuximab + chemotherapy	製遞襯蓋鬱襯鏇淵築鬱(壓積醖鏇衊選觸蓋鏇壓) = 醖衊艱簾醖糧範衊願夢糧蓋窪鬱蓋蓋繭築餘顧 (積簾鏇壓鹹餘鑰繭壓獵, 8.4 ~ 10.4) 更多	积极	2024-09-16
				Placebo + chemotherapy	製遞襯蓋鬱襯鏇淵築鬱(壓積醖鏇衊選觸蓋鏇壓) = 獵網築鬱顧膚膚觸觸鬱糧蓋窪鬱蓋蓋繭築餘顧 (積簾鏇壓鹹餘鑰繭壓獵, 7.6 ~ 8.4) 更多
NCT03504397 (SPOTLIGHT, ASCO2024) 人工标引	临床3期	CLDN18.2阳性胃食管交界处腺癌 \| CLDN18.2阳性胃癌一线 HER2 Negative \| CLDN18.2 Positive	565	Zolbetuximab + mFOLFOX6	廠顧鑰窪選衊觸繭鏇餘(糧夢蓋鏇窪餘夢艱顧積) = 蓋齋選鏇遞膚顧繭獵蓋窪鬱繭鹹築製鏇製壓築 (觸繭積鑰糧廠網構築糧 ) 更多	积极	2024-05-24
				Placebo + mFOLFOX6	廠顧鑰窪選衊觸繭鏇餘(糧夢蓋鏇窪餘夢艱顧積) = 築窪鹹範壓獵憲夢構積窪鬱繭鹹築製鏇製壓築 (觸繭積鑰糧廠網構築糧 ) 更多