A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

开始日期2026-02-03

申办/合作机构

AstraZeneca PLC

NCT07143604

/ Recruiting临床2期

A Phase II, Multicentre, Open-label, Single-arm Study of AZD0901 Monotherapy in Second-or Later-Lines Adult Participants With Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

The purpose of this study is to measure the efficacy and safety of AZD0901 monotherapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.

开始日期2025-08-29

申办/合作机构

AstraZeneca PLC

NCT07069712

/ Recruiting临床2期

A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)

GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.

开始日期2025-07-17

申办/合作机构

AstraZeneca PLC

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100 项与 Sonesitatug vedotin 相关的专利（医药）

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项与 Sonesitatug vedotin 相关的文献（医药）

2026-12-31·mAbs

Antibodies to watch in 2026

Review

作者: Pinto, Kieran ; Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Reichert, Janice M. ; Chenoweth, Alicia ; Hsu, Yu-Shin

The Antibodies to Watch article series provides annual updates on commercial late-stage clinical development, regulatory review, and marketing approvals of antibody therapeutics. Since the first article was published in 2010, the late-stage pipeline has grown from 26 antibody therapeutics to over 200, while during the same time numerous molecules in late-stage studies either transitioned to regulatory review and were approved or were terminated. In this installment of the series, we recap first marketing approvals granted to 19 antibody therapeutics in 2025, discuss 26 molecules currently in regulatory review, including the bispecific antibody-drug conjugate izalontamab brengitecan, and predict which molecules of the 209 currently in the commercial late-stage pipeline might transition to regulatory review by the end of 2026. Most antibody therapeutics in the latter category are for non-cancer indications (16/21, 76%) and have a conventional format (13/21, 62%), but the category also includes numerous antibody-oligo or -drug conjugates, such as delpacibart etedesiran, delpacibart zotadirsen, zeleciment rostudirsen, sonesitatug vedotin, trastuzumab pamirtecan, and ifinatamab deruxtecan, as well as the bispecific petosemtamab. As antibody therapeutics development is a global enterprise, we also discuss trends in annual first approvals granted to antibody therapeutics in any country since 2010, stratified by the antibody's country of origin, documenting the notable increases in the total number of first approvals and those approved first in China. Finally, to benchmark the time typically required for clinical development and regulatory review, we calculated this period for recently approved antibody therapeutic products stratified by their therapeutic area, mechanism of action, format, and country of origin. Our data show that the development and approval period were typically ~6 years, but on average this period was shorter for China-originated products.

2025-02-01·LANCET ONCOLOGY

Claudin 18.2-targeting antibody–drug conjugate CMG901 in patients with advanced gastric or gastro-oesophageal junction cancer (KYM901): a multicentre, open-label, single-arm, phase 1 trial

Article

作者: Wang, Zhen-Ning ; Shi, Xi ; Yang, Jian-Wei ; Luo, Su-Xia ; Liu, Fu-Rong ; Chen, Zhen-Dong ; Wu, Xiao-Jie ; Zhuang, Zhi-Xiang ; Ruan, Dan-Yun ; Chen, Bo ; Liang, Xiao-Hua ; Xu, Rui-Hua ; Liu, Fu-Nan ; Kumar, Rakesh ; Wei, Xiao-Li ; Zheng, Yu-Long ; Liu, Wei ; Zhang, Yan-Qiao ; Wang, Jun-Ye ; Zhang, Dong-Sheng ; Wang, Yong-Sheng ; Liu, Jian

BACKGROUND:

CMG901 is a novel first-in-class antibody-drug conjugate with a humanised anticlaudin 18.2 antibody linked to microtubule-disrupting agent monomethyl auristatin E. We aimed to assess the antitumour activity and safety of CMG901 in patients with advanced gastric or gastro-oesophageal junction cancer and other solid tumours.

METHODS:

KYM901 is a multicentre, open-label, single-arm, phase 1 trial consisting of dose-escalation and dose-expansion stages. Patients with advanced solid tumours, including gastric or gastro-oesophageal junction and pancreatic cancers, were recruited from 31 hospital sites in China. Eligible patients were aged 18 years or older, were refractory to standard therapy or had no available standard-of-care regimen, and had an Eastern Cooperative Oncology Group performance status score of 0-1, a life expectancy of at least 3 months, and at least one measurable lesion. Patients received intravenous CMG901 every 3 weeks (0·3-3·4 mg/kg in dose escalation and 2·2-3·0 mg/kg in dose expansion) until disease progression, unacceptable toxic effects, initiation of new antitumour therapy, study withdrawal, or death. Primary endpoints were adverse events and dose-limiting toxic effects in the dose-escalation phase, and objective response rate and recommended phase 2 dose in the dose-expansion phase. Confirmed objective response was defined as a partial or complete response that was verified by follow-up imaging at least 4 weeks after the initial assessment. Safety was assessed in all patients who received at least one dose of CMG901 with at least one post-dose safety evaluation. Antitumour activity was assessed in all patients who received at least one dose of CMG901 (full analysis set) and in all CMG901-treated patients with at least one post-dose imaging evaluation and no major protocol deviations (efficacy analysis set). Dose-expansion data for patients with pancreatic cancer will be published separately. Due to small sample sizes, results in patients with other solid tumours (n=2) are not planned for publication. This ongoing trial is registered with ClinicalTrials.gov, NCT04805307.

FINDINGS:

Between Dec 24, 2020, and Feb 23, 2023, 27 patients were enrolled in the dose-escalation phase (median age 57·0 years [IQR 48·0-63·0]; 14 [52%] male, 13 [48%] female) and 107 patients with gastric or gastro-oesophageal junction cancer in the dose-expansion phase (median age 56·0 years [44·0-64·0]; 57 [53%] male, 50 [47%] female). As of Feb 24, 2024, one dose-limiting toxic effect (grade 3 pancreatitis) occurred at 2·2 mg/kg, and the maximum tolerated dose was not reached in the dose-escalation phase. All 27 patients reported at least one treatment-emergent adverse event, most frequently vomiting (19 [70%]), decreased appetite (16 [59%]), proteinuria (16 [59%]), and anaemia (15 [56%]), and five (19%) had drug-related grade 3 or worse treatment-emergent adverse events. In 107 patients, grade 3 or worse treatment-emergent adverse events occurred in 73 (68%) patients and serious adverse events occurred in 54 (50%) patients in dose expansion. The most common grade 3-4 adverse events were neutrophil count decreased (22 [21%]), anaemia (15 [14%]), and vomiting (11 [10%]). One treatment-related death was reported. At median follow-up of 9·0 months (IQR 4·4-12·9), among 113 patients with gastric or gastro-oesophageal junction cancer in the 2·2-3·0 mg/kg cohort full analysis set across both the dose-escalation and dose-expansion phases, the confirmed objective response rate was 28% (95% CI 20-38; 32 of 113 patients). In the 109 patients included in the efficacy analysis set, the confirmed objective response rate was 29% (95% CI 21-39; 32 of 109 patients). Based on overall safety, activity, and pharmacokinetics of CMG901, 2·2 mg/kg was the proposed recommended phase 2 dose.

INTERPRETATION:

CMG901 showed a manageable safety profile and had promising antitumour activity in patients with advanced gastric or gastro-oesophageal junction cancer.

FUNDING:

KYM Biosciences.

2024-09-01·Cell Reports Medicine

CMG901, a Claudin18.2-specific antibody-drug conjugate, for the treatment of solid tumors

Article

作者: Wang, Ying ; Chen, Bo ; Zhang, Libo ; Xu, Ruihua ; He, Yanyun ; Liu, Wei ; Song, Qin ; Wei, Xiaoli ; Li, Zhiyao ; Liu, Furong ; Xu, Gang ; Wang, Changyu

Claudin18.2 has been recently recognized as a potential therapeutic target for gastric/gastroesophageal junction or pancreatic cancer. Here, we develop a Claudin18.2-directed antibody-drug conjugate (ADC), CMG901, with a potent microtubule-targeting agent MMAE (monomethyl auristatin E) and evaluate its preclinical profiles. In vitro studies show that CMG901 binds specifically to Claudin18.2 on the cell surface and kills tumor cells through direct cytotoxicity, antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and bystander killing activity. In vivo pharmacological studies show significant antitumor activity in patient-derived xenograft (PDX) models. Toxicity studies show that the major adverse effects related to CMG901 are reversible hematopoietic changes attributed to MMAE. The highest non-severely toxic dose (HNSTD) is 6 mg/kg in cynomolgus monkeys and 10 mg/kg in rats once every 3 weeks. CMG901's favorable preclinical profile supports its entry into the human clinical study. CMG901 is currently under phase 3 investigation in patients with advanced gastric/gastroesophageal junction adenocarcinoma expressing Claudin18.2 (NCT06346392).

460

项与 Sonesitatug vedotin 相关的新闻（医药）

2026-02-27

·雪球

TST001 III 期数据发布时间分析

结合**创胜集团官方披露信息、Claudin18.2胃癌领域III期临床试验行业惯例、港股创新药企业数据发布规律**三大维度分析，**TST001（TranStar301试验）的III期顶线数据大概率将在2026年**Q3-Q4**发布，核心窗口期为2026年9-12月**，若试验数据超预期或统计效率提升，不排除提前至2026年Q2末披露的可能，以下为具体推导依据：###一、核心依据：公司官方披露的试验推进节奏与时间指引创胜集团在2025年中报、2025年ASCO年会公告、官网管线进展中，多次明确TST001III期试验的核心时间特征，为数据发布划定**明确的时间框架**：1.**试验收官阶段的时间节点**：公司2026年2月最新公告仍标注TST001III期为「全球多中心试验进入收官阶段」，而该试验于**2024年正式启动中美韩同步入组**，结合胃癌III期临床试验**18-24个月**的常规周期，2026年下半年为数据锁定并披露的合理时间；2.**无提前入组完成的公告，排除Q1-Q2早披露可能**：港股创新药企业若临床试验提前完成入组/数据锁定，会第一时间发布公告（如和黄医药2025年8月公告赛沃替尼III期入组完成，2026年1月即披露数据），而创胜集团截至2026年2月未发布任何TST001III期入组提前完成的公告，因此**2026年Q1-Q2披露数据的概率极低**；3.**公司对2026年的核心研发指引**：创胜集团在2025年投资者交流中明确，「2026年为公司核心管线临床数据兑现年，TST001III期数据为全年最重要里程碑」，结合港股药企惯例，核心数据通常会在**年内业绩披露前（12月）或下一年业绩会前（次年3月）**发布，而TST001作为全球管线，更倾向于在**2026年年内披露**以推动后续BD合作与上市申报。###二、行业惯例：Claudin18.2胃癌III期试验的周期与数据发布规律从Claudin18.2胃癌领域的III期临床试验行业基准，及胃癌肿瘤药研发的通用规律，可进一步验证TST001的时间窗口：1.**同靶点竞品的III期周期参考**：安斯泰来Zolbetuximab的Claudin18.2胃癌一线III期试验（SPOTLIGHT）从启动入组到披露顶线数据耗时**22个月**，而TST001III期试验入组人群更广（覆盖55%胃癌患者）、全球多中心中心数更多，**周期略长于竞品为行业常态**，对应2024年启动入组，2026年Q3-Q4披露数据完全符合惯例；2.**胃癌III期试验的核心时间要求**：胃癌作为实体瘤，III期试验的**主要终点为中位无进展生存期（mPFS）**，需达到**事件数（疾病进展/死亡）80%以上**才能进行统计分析，而胃癌患者的mPFS通常为6-16个月（TST001II期为16.6个月），从入组完成到事件数达标需**6-9个月**的随访时间，结合TST001入组收官的时间节点，2026年Q3才能完成足够随访并锁定数据；3.**跨国药企同赛道试验的时间参考**：阿斯利康Claudin18.2胃癌二线III期试验（AZD0901）于2024年3月启动，预计2026年5月完成主要终点、9月完成研究，这一节奏与TST001高度契合，印证了**2026年下半年为Claudin18.2胃癌III期数据的核心披露期**。###三、港股创新药企业的**数据发布惯例**：契合业绩周期与学术会议节点创胜集团作为港股上市生物药企，其数据发布节奏将贴合港股市场的**业绩披露规律**与**全球权威肿瘤学术会议节点**，这也是推导时间窗口的重要参考：1.**避开业绩真空期，贴合核心业绩节点**：港股药企通常不会在业绩真空期（如Q1）披露核心管线数据，更倾向于在**中报后（Q3）**或**年报前（Q4）**发布，一方面可配合业绩交流会传递研发进展，另一方面可借助数据利好提振股价；创胜集团2026年中报预计8月披露，Q3（9-10月）成为披露TST001数据的首个窗口期；2.**匹配全球肿瘤学术会议节点**：肿瘤药III期核心数据通常会选择在**ESMO（9月）、ASCOGI（1月）、AACR（4月）**等权威学术会议披露，而**2026年ESMO年会（9月，欧洲肿瘤内科学会）**是TST001III期数据的最优披露节点——既符合试验数据锁定时间，又能借助国际学术平台提升数据公信力，为后续全球上市申报与BD合作奠定基础；若数据未能赶上ESMO，則**2026年12月的公司官方公告**为次优选择。3.**BD合作驱动的时间要求**：创胜集团在2025年多次公告「TST001已收到多家跨国药企的BD合作条款清单」，而跨国药企的BD合作通常需**以III期顶线数据为核心依据**，结合药企年度合作规划，**2026年Q4前披露数据**可推动合作在2027年落地，符合公司的商业化战略。###四、补充：可能的**时间偏差**与**提前披露的触发条件**以上为基于行业惯例的核心时间推导，实际发布时间可能存在**1-3个月**的偏差，而**提前披露的唯一核心触发条件为「试验数据显著超预期，达到提前统计终止标准」**：1.**提前披露的可能性**：若TST001III期试验在随访中，**mPFS/mOS显著优于预设优效性阈值，且安全性无问题**，经独立数据监察委员会（IDMC）评估后，可提前终止试验并披露数据，此时可能提前至**2026年Q2末（6-7月）**；但截至2026年2月，公司未发布任何IDMC会议或提前终止试验的公告，该情况发生概率较低；2.**延后披露的风险**：若试验中出现**少量患者随访数据缺失、统计分析流程复杂**等问题，数据发布时间可能延后至**2027年Q1（1-3月）**，但结合公司现金流与BD合作需求，延后披露的可能性极低，公司大概率会在2026年年内完成数据发布。###总结：TST001III期数据的**核心时间窗口与概率分布**综合所有依据，TST001III期顶线数据的发布时间可明确为**2026年下半年**，具体概率分布如下：1.**核心窗口期（70%概率）**：**2026年9-10月**（匹配ESMO年会+中报后业绩交流）；2.**次优窗口期（20%概率）**：**2026年11-12月**（公司官方公告形式，为年报做铺垫）；3.**小概率提前（10%概率）**：**2026年6-7月**（数据超预期并提前终止试验）。**关键跟踪节点**：若2026年6-8月创胜集团发布「TST001III期试验完成数据锁定」或「IDMC建议提前终止试验」的公告，则标志着数据将在**1-2个月内披露**，为最直接的时间信号。

2026-02-26

·证券之星

乐普生物-B（02157.HK）：2月26日南向资金增持125.5万股

证券之星消息，2月26日南向资金增持125.5万股乐普生物-B（02157.HK）。近5个交易日中，获南向资金增持的有4天，累计净增持353.9万股。近20个交易日中，获南向资金增持的有17天，累计净增持2013.0万股。截至目前，南向资金持有乐普生物-B（02157.HK）4.88亿股，占公司已发行普通股的27.01%。乐普生物科技股份有限公司是一家主要从事医药产品销售及新药研发的公司。该公司聚焦于肿瘤治疗领域，尤其是靶向治疗及免疫治疗。该公司致力于通过抗体药物偶联物（ADC）技术开发平台开发创新型ADC。该公司的临床阶段候选药物涵盖靶向疗法药物和一种免疫治疗药物，具体包括MRG003、MRG002、CMG901、MRG004A、CG0070、MRG006A、MRG007、CTM012等。以上内容为证券之星据公开信息整理，由AI算法生成（网信算备310104345710301240019号），不构成投资建议。

2026-02-26

·搜狐新闻

乐普生物-B：南向资金大幅增持，肿瘤治疗新希望！

在当今医疗科技飞速发展的时代，您是否关注过那些致力于改善我们健康的生物医药公司？近日，乐普生物-B（02157.HK）引起了市场的广泛关注，尤其是南向资金在2月26日增持了125.5万股，这一变化背后又隐藏着怎样的故事呢？乐普生物是一家专注于医药产品销售和新药研发的公司，尤其在肿瘤治疗领域表现突出。公司致力于开发靶向治疗和免疫治疗药物，利用抗体药物偶联物（ADC）技术开发创新型药物，旨在为患者提供更有效的治疗方案。当前，乐普生物的临床候选药物包括MRG003、MRG002、CMG901等，这些药物的研发进展可能对未来的癌症治疗产生深远影响。在过去的五个交易日中，南向资金连续四天增持乐普生物，累计增持达到353.9万股。而在更长的时间范围内，过去20个交易日中，该公司也获得了17天的资金增持，累计增持高达2013.0万股。这些数据反映了投资者对乐普生物未来发展的信心，以及市场对其研发成果的期待。对于广大关注健康的人士来说，肿瘤治疗的进展无疑是一个重要话题。根据最新研究，靶向治疗和免疫治疗相较于传统化疗，能够更有效地针对癌细胞，减少对正常细胞的损伤，提高患者的生活质量。因此，乐普生物的研发成果可能会为很多癌症患者带来新的希望。在日常生活中，除了关注医疗技术的发展，我们自身的健康管理同样不可忽视。保持健康的生活方式，包括均衡饮食、适量运动、良好的心理状态，对于预防癌症等重大疾病至关重要。专家建议，日常饮食中应多摄入富含抗氧化物的食物，如新鲜水果和蔬菜，适量摄入全谷物和优质蛋白质，保持体重在健康范围内，同时，定期进行健康体检，早发现、早治疗。对于不同年龄段的人群，健康管理的重点也有所不同。年轻人应注重锻炼和心理健康，而中老年人则需要更加关注慢性病的管理和定期检查。无论年龄如何，保持积极的生活态度和健康的生活习惯，都是维护身体健康的关键。乐普生物的股市动态不仅反映了市场对其潜力的认可，也提醒我们关注健康产业的最新进展。随着生物医药科技的不断创新，我们期待未来能够有更多的创新疗法问世，为患者带来新的希望和选择。让我们共同关注乐普生物及其在肿瘤治疗领域的突破，同时也不忘在生活中践行健康的理念。返回搜狐，查看更多

100 项与 Sonesitatug vedotin 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
食管腺癌	临床3期	美国	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	中国	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	日本	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	澳大利亚	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	奥地利	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	比利时	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	巴西	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	加拿大	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	德国	AstraZeneca PLC	2026-02-03
食管腺癌	临床3期	匈牙利	AstraZeneca PLC	2026-02-03

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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


NCT04805307 (KYM901, Pubmed) 人工标引	临床1期	胃食管交界处癌 \| 晚期胃癌二线 CLDN18.2 Positive	134	CMG901	衊鏇襯鹽憲顧鬱餘簾憲(蓋蓋衊鹽遞壓餘膚鏇糧) = 遞製願衊廠衊鏇鏇鑰鹹淵餘範襯構淵觸選獵鹹 (膚選願憲齋選網衊艱壓, 21 ~ 39) 更多	积极	2025-01-06
				CMG901 (dose-escalation phase)	願製鑰獵淵衊鹽鹽鹹鹽(簾鏇醖餘糧鹹範獵鑰觸) = 願獵壓獵齋鏇糧糧夢淵繭製憲遞獵壓鹹築觸醖 (廠積鑰觸範選簾築壓淵 )
NCT04805307 (KYM901, NEWS) 人工标引	临床1期	晚期胃癌	113	CMG901	夢觸顧獵餘淵鹽構膚窪(鑰網簾觸衊獵獵鬱顧網) = 積鏇範憲遞淵夢繭鏇獵築製鹽艱簾齋蓋鬱壓顧 (廠繭選鏇憲願廠醖範觸 ) 更多	积极	2024-06-03
				CMG901 (2.2 mg/kg)	夢觸顧獵餘淵鹽構膚窪(鑰網簾觸衊獵獵鬱顧網) = 鹽膚獵鏇網壓淵製蓋淵築製鹽艱簾齋蓋鬱壓顧 (廠繭選鏇憲願廠醖範觸 )
NCT04805307 (ASCO_GI2023) 人工标引	临床1期	CLDN18.2阳性胃食管交界处腺癌 \| CLDN18.2阳性胰腺癌 \| CLDN18.2阳性胃癌 CLDN18.2-positive	27	CMG901	糧餘願網夢鬱膚窪鑰鏇(憲衊齋糧淵壓簾鏇選夢) = 衊遞壓選範鬱鏇艱構觸夢築積構鹽衊夢膚衊窪 (壓積憲構構襯願蓋製鑰 )	积极	2023-01-24
				CMG901 (CLDN18.2-positive Gastric/GEJ Cancer)	簾製憲簾憲繭範積窪構(鬱醖選構鏇鑰餘淵繭餘) = 繭齋鹽鏇構獵憲願糧膚鏇觸淵繭餘鏇顧醖廠夢 (艱遞遞構艱壓範構鹹顧 ) 更多