盐酸伊立替康(Irinotecan Hydrochloride) - 药物靶点：Top I_在研适应症：转移性胰腺腺癌，儿童恶性实体瘤，肠肿瘤_专利_临床

概要

基本信息

药物类型

小分子化药

别名

ASC-201 - Ascelia Pharma、irinotecan、Irinotecan hydrochloride (USP)

+ [38]

靶点

Top I

作用方式

抑制剂

作用机制

TOP1抑制剂(DNA拓扑异构酶I抑制剂)

治疗领域

肿瘤免疫系统疾病消化系统疾病+ [7]

在研适应症

转移性胰腺腺癌儿童恶性实体瘤肠肿瘤+ [31]

非在研适应症

腺癌食管腺癌大肠腺癌+ [63]

原研机构

Yakult Honsha Co., Ltd.

在研机构

Daiichi Sankyo Co., Ltd.

Eli Lilly & Co.

Yakult Honsha Co., Ltd.

+ [12]

非在研机构

Sanofi

Bristol Myers Squibb Co.

Pharmacia Corp.

+ [14]

权益机构

Merrimack Pharmaceuticals, Inc.

Elevation Oncology, Inc.

广州市香雪制药股份有限公司

+ [7]

最高研发阶段批准上市

首次获批日期

日本 (1994-01-19),

非小细胞肺癌卵巢癌胰腺癌+ [3]

最高研发阶段(中国)批准上市

特殊审评优先审评 (中国)、孤儿药 (韩国)、加速批准 (美国)

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结构/序列

分子式C33H45ClN4O9

InChIKeyKLEAIHJJLUAXIQ-JDRGBKBRSA-N

CAS号136572-09-3

关联

1,538

项与盐酸伊立替康相关的临床试验

NCT06846346

/ Not yet recruiting临床2期IIT

Phase II Study Evaluating Ivonescimab in Combination With Chemotherapy for First- and Second-line Treatment of Advanced or Metastatic Gastric and Gastroesophageal Adenocarcinoma Patients

The goal of this clinical trial is to evaluate the addition of ivonescimab to standard chemotherapy in patients with advanced or metastatic gastric and gastroesophageal adenocarcinoma. The main question it aims to answer is : Does the addition of ivonescimab increase the response to treatment ? Participants will visit the clinic every 2 weeks for checkups, treatment administration and tests for collection of adverse events.

开始日期2025-09-01

申办/合作机构

UNICANCER

[+1]

NCT06820957

/ Not yet recruiting临床2/3期IIT

Randomized Phase 2/3 Trial of Vincristine-Irinotecan-Regorafenib in Combination With Vincristine-Doxorubicin-Cyclophosphamide (VDC) and Ifosfamide-Etoposide (IE) in Patients With Newly Diagnosed Metastatic Ewing Sarcoma

This phase II/III trial compares the effect of vincristine, irinotecan, and regorafenib (VIrR) in combination with vincristine, doxorubicin, cyclophosphamide (VDC), ifosfamide and etoposide (IE) to usual treatment with VDC/IE for the treatment of newly diagnosed Ewing sarcoma or other round cell sarcomas that have spread from where they first started (primary site) to other places in the body (metastatic). Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Regorafenib, a type of kinase inhibitor and a type of antiangiogenesis agent, blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Ifosfamide, a type of alkylating agent and a type of antimetabolite, attaches to DNA in cells and may kill tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Giving VIrR/VDC/IE may be more effective than usual treatment with VDC/IE in treating patients with newly diagnosed metastatic Ewing sarcoma or other round cell sarcomas.

开始日期2025-07-15

申办/合作机构

The Children's Oncology Group Foundation, Inc.

NCT06620302

/ Not yet recruiting临床1/2期IIT

DT2216 in Combination With Irinotecan for Children, Adolescents and Young Adults With Relapsed or Refractory Solid Tumors: A Phase I Study With Phase II Feasibility Cohort for Fibrolamellar Carcinoma

This phase I/II trial tests the safety, side effects and best dose of DT2216 in combination with irinotecan and how well it works in treating children, adolescents and young adults with solid tumors and fibrolamellar cancer that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). DT2216 is an anti-apoptotic protein B-cell lymphoma-extra large targeted protein degrader. It may stop the growth of tumor cells by blocking BCL-XL, a protein needed for tumor cell survival. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Giving DT2216 in combination with irinotecan may be safe, tolerable, and/or effective in treating children, adolescents and young adults with relapsed or refractory solid tumors or fibrolamellar cancer.

开始日期2025-06-20

申办/合作机构

The Children's Oncology Group Foundation, Inc.

100 项与盐酸伊立替康相关的临床结果

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100 项与盐酸伊立替康相关的转化医学

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100 项与盐酸伊立替康相关的专利（医药）

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12,186

项与盐酸伊立替康相关的文献（医药）

2025-12-31·AUTOIMMUNITY

Deciphering distinct pathogenic mechanisms of ankylosing spondylitis and systemic sclerosis via shared biomarkers ZSWIM6 and CCL3L3: Insights from an integrative bioinformatics approach

Article

作者: Zhou, Chenxing ; Chen, Jiarui ; Zhan, Xinli ; Xue, Jiang ; Shi, Jianjun ; Zhou, Zhongxian ; Yang, Renbang ; Huang, Liangyu ; Huang, Chengqian ; Liu, Chong ; Chen, Tianyou ; Feng, Sitan ; Huang, Jieping ; Wu, Shaofeng ; Zhu, Jichong

Ankylosing Spondylitis (AS) and Systemic Sclerosis (SSc) are both autoimmune diseases, albeit with distinct anatomical targets. AS primarily affects the spine and sacroiliac joints, triggering inflammation and eventual fusion of the vertebrae. SSc predominantly impacts the skin and connective tissues, leading to skin fibrosis, thickening, and potential damage to vital organs such as the lungs, heart, and kidneys. Despite their differing anatomical manifestations, inflammation serves as a pivotal factor in both conditions. Exploring the causes of the different pathogenesis of inflammation in AS and SSc could provide new insights into their treatment. We selected RNA-seq profiles of peripheral blood mononuclear cells (PBMCs) from the GEO datasets GSE73754 and GSE19617. DEGs were identified using the Limma R package with an adjusted p-value cutoff of < 0.05. Gene Ontology pathway analysis, SVM recursive feature elimination, and Gene Set Enrichment Analysis (GSEA) were conducted to analyze the DEGs. CIBERSORT was applied to estimate immune cell composition and its correlation with hub genes. Single-cell RNA sequencing data from peripheral blood mononuclear cells in the GSE194315 dataset were included to support differential expression analysis and biomarker identification. Additionally, single-cell RNA sequencing data from bone marrow blood samples were utilized to further validate these findings, offering complementary insights into biomarker expression across distinct sample types. A total of 762 DEGs were identified between AS patients and controls, and 441 DEGs between SSc patients and controls. Both conditions showed enrichment in the Natural killer cell mediated cytotoxicity pathway. ZSWIM6 and CCL3L3 were identified as potential biomarkers in AS and SSc, with significant diagnostic capabilities demonstrated by ROC analysis. Correlation analysis revealed associations between these biomarkers and specific immune cell types. The study utilizing ZSWIM6 and CCL3L3 as potential biomarkers provides deep insights into the distinct molecular mechanisms of SSc and AS. These findings lay the foundation for future research on targeted therapies and enhance our understanding of immune cell interactions in these autoimmune diseases.

2025-08-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Simultaneous analysis of various anticancer drugs by supercritical fluid chromatography-mass spectrometry. Part I: Optimization of chromatographic separation

Article

作者: Guillarme, Davy ; Rudaz, Serge ; Fleury-Souverain, Sandrine ; Bonnabry, Pascal ; Nguyen, Nathalie

This work presents a generic SFC-MS method for the simultaneous analysis of 22 anticancer drugs (fluorouracil, busulfan, cyclophosphamide, cytarabine, dacarbazine, daunorubicin, docetaxel, doxorubicin, epirubicin, etoposide, gemcitabine, idarubicin, ifosfamide, irinotecan, methotrexate, paclitaxel, pemetrexed, raltitrexed, topotecan, treosulfan, vinblastine, vincristine). The separation conditions were optimized by screening nine stationary phases (2-picolylamine, bare hybrid silica, 2-ethylpyridine, fluoro-phenyl, octadecyl, diethylamine, diol, 1-aminoanthracene, zwitterionic modification), evaluating additives effects (2-5 % water, 20-50 mM ammonium formate, 0-1 mM ammonium fluoride), and adjusting the organic modifier composition (methanol, ethanol, isopropanol, acetonitrile). The optimized SFC-MS method successfully analyzed 22 anticancer drugs, along with 5 additional challenging compounds (azacitidine, mitomycin, cisplatin, oxaliplatin, carboplatin), in 12 min, using a diol column (100 × 3 mm, 1.7 µm) and a gradient of 2-100 % methanol containing 2 % water and 50 mM ammonium formate. To overcome overpressure generated by high organic solvent content, a backpressure gradient (110-150 bar) and a flow rate gradient (0.6-1.5 mL/min) were applied. The diol column was selected as the most promising based on five predefined chromatographic criteria. Additives with 5 % water or ammonium fluoride were excluded due to overpressure and signal loss, respectively. Increasing ammonium formate concentration improved peak symmetry by 29 %. For the organic modifier, pure methanol was chosen since ternary mixtures led to system overpressure without improving separation. Comparison with the LC-MS method using real samples confirmed the potential applicability of the SFC method, as the same trace compounds were detected with comparable concentrations. Sensitivity optimization and method validation will be discussed separately in a later paper.

2025-07-01·GENE

In vitro investigation of epigenetic regulators related to chemo-resistance and stemness of CD133+VE cells sorted from U87MG cell line

Article

作者: Shahin, Diana ; Awidi, Abdalla S ; Barham, Raghad ; Aslam, Nazneen ; Saadeh, Heba ; Zihlif, Malek A ; Wehaibi, Suha ; Abuarqoub, Duaa ; Abusharieh, Elham ; Bustanji, Yasser

Glioblastoma (GBM) is the most common and malignant adult primary brain tumor with frequent relapse and resistance to therapies. Glioma stem cells, a rare population, is thought to be the reason behind the treatment's failure. It is imperative to investigate the disease mechanisms and identify the biomarkers by which glioma stem cells would contribute to treatment relapse and resistance to already available chemotherapeutic agents. The CD133^+VE cells were isolated from U87MG cell line and characterized by morphological features, cell viability, self-renewal efficiency, migration potential and karyotyping. Doxorubicin Cisplatin, Irinotecan, Etoposide and Temozolomide were used to determine the anti-proliferative effect on CD133^+VE cells. Confocal microcopy was used to localize the chemotherapeutic agents in the CD133^+VE cells. In quest of epigenetic biomarkers, RNA sequencing was performed to find the role of lncRNAs in stemness and resistance to therapies. U87cell line and CD133^-VE cells were kept as controls for all the experiments. It was found that CD133^+VEcells were highly proliferative with increased migration potential, elevated IC50 values against chemotherapeutic agents and showed distinct karyotyping related to pluripotency. Chemotherapeutic agent such as Doxorubicin was localized outside the nucleus revealing the drug resistance as evident by confocal microscopy. RNA sequencing revealed 126 differentially expressed lncRNAs (DELs) in CD133^+VEcells among which lncRNA LOXL1-AS1 was highly upregulated and lncRNA PAX8-AS1 was significantly downregulated. These lncRNAs has been reported to be related to drug resistance, migration and epithelial- to- mesenchymal transmission (EMT), self-renewal and stemness properties contributing to poor prognosis and disease relapse.

1,208

项与盐酸伊立替康相关的新闻（医药）

19 小时之前

·微信

抗体药物接连出海，总额超17.5亿美元

正文共2500字预计阅读时间7分钟近年来，国内创新药步入快速发展期。而基于实力增加、开放合作以及自身发展的需要，越来越多本土药企将目光投向海外市场，寻求更广阔的发展空间，创新药出海成为趋势。其中，抗体药物凭借相对频繁的海外上市和License out交易，成为创新出海的佼佼者。仅5月的尾声，就传来了两款创新药出海的好消息。先是2025年5月27日，岸迈生物将以2.1亿美元与NewCo达成出海合作。到了5月30日，信诺维医药又以15.4亿美元与安斯泰来达成出海合作。前者聚焦于T细胞的“精准制导武器TCE双抗、后者则是出海的大热门ADC。无论是“争做吃螃蟹的人”，还是选择“在红海市场打造差异化的帆”，他们都彰显出了中国企业的智慧与勇敢。岸迈生物：争做吃螃蟹的人2025年5月27日，岸迈生物宣布与NewCo旗下TCG Labs Soleil投资组合公司Juri Biosciences签署一项全球许可协议。根据该协议，Juri Biosciences获得了岸迈生物针对转移性前列腺癌开发的靶向激肽释放酶相关肽酶2（KLK2）和CD3的双特异性抗体TCE（T细胞接合器）的全球独家授权。根据协议条款，岸迈生物有权收取高达2.1亿美元的资金，包括首付款，和开发、注册和商业化相关的里程碑付款，以及特许权使用费。KLK2因其在肿瘤组织中高度特异性的表达而受到广泛关注，尤其在非前列腺组织中几乎不表达，因此成为前列腺癌治疗的理想靶点。目前全球范围内专注于KLK2靶点开发的企业相对较少，其中强生公司已将其列为前列腺癌领域重点布局的靶点，并在该领域开展了包括TCE双抗、RLT（放射性配体疗法）和CAR-T等多种治疗方式的研发。CD3/KLK2 TCE赛道在全球范围内尚处于早期阶段。回看国内，岸迈生物争做吃螃蟹的人，此次合作将海外权益授予经验丰富的TCG Labs Soleil团队支持下的合作伙伴Juri，有助于分担开发压力，持续验证其TCE平台在超越免疫学和血液学之外的广阔潜力。这一合作有望加速将KLK2/CD3 TCE推进至临床阶段，为全球转移性前列腺癌患者带来新的治疗希望。对于Juri而言，选择拥有底层技术平台的岸迈生物作为合作伙伴是明智之举。业内素有“双抗看平台”的说法，而岸迈生物凭借其自主研发的FIT-Ig和MAT-Fab双特异性抗体技术平台，在行业内占据领先地位。其中FIT-Ig采用"2+2"四价双抗设计，能够通过分子生物学手段将两个单抗序列糅合在一起形成一种结构独特的双特异性抗体，是全球唯一的既不需要任何氨基酸突变、也不包含连接肽链及任何非抗体序列的双特异性抗体技术，具备很高的成药性和产业化效率。此外，岸迈生物还建立了CD3结合域库，为TCE分子开发提供了关键优势。CD3结合域库提供多样化的CD3结合臂，优化亲和力以平衡疗效与安全性，特别是在降低细胞因子释放综合征（CRS）风险方面表现突出。例如，岸迈生物自主研发的靶向BCMA TCE候选药物EMB-06在临床试验中展现出极低的CRS发生率（仅1级），并具有良好的安全性特征。值得一提是，2024年9月，Foresite Labs孵化并由Foresite Capital投资的Vignette Bio，与岸迈生物就EMB-06达成授权许可协议。岸迈生物也由此开启了备受关注的出海新征程。信诺维：在红海中打造差异化的帆时间来到了2025年5月30日，信诺维医药（以下简称“信诺维”）宣布与安斯泰来达成一项独家许可协议，授权其自主研发的的靶向CLDN18.2的ADC药物XNW27011 在全球（除中国大陆、香港、澳门和台湾地区外）开发和商业化的权利。依据协议条款，信诺维将获得1.3亿美元的首付款，并有资格收取最高7000万美元的近期付款，以及最高可达13.4亿美元的与开发、注册、商业化相关的里程碑付款（总计15.4亿美元）。此外，若XNW27011获批上市，信诺维还将获得该产品净销售额的特许权使用费。Claudin18.2（CLDN18.2）是一种在胃、胰腺和其他实体瘤中广泛表达的肿瘤相关抗原，近年来成为肿瘤治疗领域的研究靶点。围绕CLDN18.2的药物研发百花齐放，涵盖单克隆抗体（mAb）、双特异性抗体（BsAb）、ADC、CAR-T和纳米抗体等。其中，多款Claudine18.2在研ADC药物处于临床1/2期及更高阶段。2024年6月，XNW27011获得FDA授予快速通道资格，用于治疗胃癌。在2024年ESMO大会上，信诺维公布了XNW27011针对局部晚期和/或转移性实体瘤患者的首次人体I期临床研究结果。数据显示，该药物即使在低剂量下（如0.6mg/kg）也展现出了疗效。对于此前接受过PD-1免疫治疗、伊立替康或CLDN18.2抗体治疗但效果不佳的患者，XNW27011仍表现出良好的疗效。从安全性来看，最常见的不良反应为恶心和呕吐，部分患者出现白细胞减少等血液系统副作用，但在推荐剂量范围内未观察到严重毒性反应。这意味着XNW27011不仅具有良好的抗肿瘤活性，还具备较好的耐受性。信诺维有望在CLDN18.2的红海中打造出差异化的帆。2025年5月16日，CDE官网显示，注射用XNW27011拟纳入突破性治疗品种，用于CLDN18.2表达的局部晚期不可切除或转移性HER2阴性胃或胃食管结合部腺癌的三线及以上治疗。目前，XNW27011研发阶段处于 1/2 期临床试验，针对实体瘤、结肠癌、胰腺导管腺癌、胆道肿瘤、胃癌等适应症开展试验。安斯泰来在创新癌症疗法的研发与商业化方面具有深厚积累，尤其在CLDN18.2靶点领域经验丰富。其孵化的威络益（VYLOY™）是全球首个获批的CLDN18.2靶向疗法。此次引入XNW27011，将进一步丰富安斯泰来在精准肿瘤学领域的研发管线，拓展其在不同适应症中的布局，并巩固其在CLDN靶点及相关ADC技术上的领先地位。值得一提的是，信诺维已与国内外知名公司达成多项授权及合作协议，潜在交易金额数十亿美元，完成五笔 license - out ，是国内生物医药领域达成 license - out 较多的企业。此次与安斯泰来的合作，不仅彰显了信诺维在ADC领域强大的自主研发能力，也标志着其全球化战略迈出坚实一步。参考资料：1.岸迈生物官方公布2.信诺维官方公布3.其他公开资料图片来源：豆包AI特大爆发！一天11款创新药获批上市！NMPA重磅官宣2025-05-29从0%到42%，中国创新药创造了历史！2025-05-28iPSC领军药企通用细胞新药获批中美药监局7项注册临床批件，细胞治疗帕金森病长期随访安全且有效2025-05-27版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn点击这里，查看更多精彩！

引进/卖出细胞疗法免疫疗法抗体药物偶联物

23 小时之前

·Antibody Research

15.4亿美元，安斯泰来引进信诺维CLDN18.2 ADC

▎追溯2025 年 5 月 30 日，信诺维医药和安斯泰来制药（东京证券交易所：4503，以下简称“安斯泰来”）宣布，双方就 XNW27011（一款靶向 CLDN18.2，处于临床阶段的新一代抗体偶联药物）已达成一项独家许可协议，授予安斯泰来独家拥有 XNW27011 在全球（除中国大陆、香港、澳门和台湾地区外）开发和商业化的权利。根据协议条款，信诺维将获得1.3亿美元的首付款，并有资格收取最高7000万美元的近期付款，以及最高可达13.4亿美元的与开发、注册、商业化相关的里程碑付款。此外，XNW27011获批上市后，信诺维还将获得该产品净销售额的特许权使用费。XNW27011 是信诺维开发的新一代抗体偶联药物（ADC），靶向 Claudin18.2。2024 年 6 月，XNW27011 获得 FDA 授予快速通道资格，用于治疗胃癌。该平台2025年5 月 16 日，CDE 官网显示，信诺维 1 类新药注射用 XNW27011 拟纳入突破性治疗品种，适应症为：用于 CLDN18.2 表达的局部晚期不可切除或转移性 HER2 阴性胃或胃食管结合部腺癌的三线及以上治疗。2024 年 ESMO 大会上，信诺维公布了 XNW27011 针对局部晚期和/或转移性实体瘤患者的首次人体 I 期临床研究结果。在该研究中，XNW27011 剂量从 0.6 mg/kg（每三周一次，静脉注射）开始，采用加速剂量递增方案，随后进行 3+3 递增。剂量递增阶段的主要目标是确定最大耐受剂量 (MTD)。截至 2024 年 4 月 15 日，共入组 16 例患者，剂量范围从 0.6 mg/kg 至 6.0 mg/kg，分为 6 个剂量组，包括 11 例胃癌/胃食管交界处腺癌、2 例卵巢癌、2 例前列腺癌和 1 例十二指肠壶腹部周围腺癌。12 例患者存在不同程度的 CLDN18.2 表达（≥1%，IHC≥1+）。在剂量限制性内镜（DLT）治疗期间，最常见的不良反应（AE）为恶心和呕吐，其次是白细胞减少、中性粒细胞减少和贫血。在剂量限制性内镜治疗期间，4.8 mg/kg 剂量以下未观察到≥3 级 TRAE。未观察到 ILD 或 MMAE 相关的眼部不良反应和周围神经病变。1 例患者在 6.0 mg/kg 剂量下出现 DLT。14 例患者可评估疗效，具体数据如下表。即使剂量低至 0.6 mg/kg，也观察到疗效。先前接受过 PD-1 免疫疗法、伊立替康或 CLDN18.2 抗体治疗的患者似乎未对疗效产生影响。欢迎加入我的知识星球，可提供专业的免费咨询，同时可以获得Antibody Research生物药随谈回放视频。公众号已经建立读者实名讨论微信群，可以添加微信（zhuisu2210）后进群，添加时请主动注明姓名、企业、职位。

免疫疗法快速通道突破性疗法引进/卖出

23 小时之前

·药研网

15.4亿美元！信诺维授权安斯泰来一款CLDN18.2 ADC

5月30 日，信诺维和安斯泰来宣布，双方就 XNW27011（一款靶向 CLDN18.2，处于临床阶段的新一代抗体偶联药物）已达成一项独家许可协议，授予安斯泰来独家拥有 XNW27011 在全球（除中国大陆、香港、澳门和台湾地区外）开发和商业化的权利。根据协议条款，信诺维将获得1.3亿美元的首付款，并有资格收取最高7000万美元的近期付款，以及最高可达13.4亿美元的与开发、注册、商业化相关的里程碑付款。此外，XNW27011获批上市后，信诺维还将获得该产品净销售额的特许权使用费。XNW27011 目前正在中国开展 1/2 期临床研究，针对表达 CLDN18.2 的实体瘤（包括胃癌、胃食管癌和胰腺癌）患者。XNW27011采用了一种专有的拓扑异构酶I抑制剂载荷和连接子技术，这类技术已在其他已获批的抗癌疗法中展现出临床获益。2024 年 6 月，XNW27011 获得 FDA 授予快速通道资格，用于治疗胃癌。2024年ESMO 大会上，信诺维公布了 XNW27011 针对局部晚期和/或转移性实体瘤患者的首次人体 I 期临床研究结果。截至 2024 年 4 月 15 日，共入组 16 例患者，剂量范围从 0.6 mg/kg 至 6.0 mg/kg，分为 6 个剂量组，包括 11 例胃癌/胃食管交界处腺癌、2 例卵巢癌、2 例前列腺癌和 1 例十二指肠壶腹部周围腺癌。12 例患者存在不同程度的 CLDN18.2 表达（≥1%，IHC≥1+）。在剂量限制性内镜（DLT）治疗期间，最常见的不良反应（AE）为恶心和呕吐，其次是白细胞减少、中性粒细胞减少和贫血。在剂量限制性内镜治疗期间，4.8 mg/kg 剂量以下未观察到≥3 级 TRAE。未观察到 ILD 或 MMAE 相关的眼部不良反应和周围神经病变。1 例患者在 6.0 mg/kg 剂量下出现 DLT。14 例患者可评估疗效，具体数据如下表。即使剂量低至 0.6 mg/kg，也观察到疗效。先前接受过 PD-1 免疫疗法、伊立替康或 CLDN18.2 抗体治疗的患者似乎未对疗效产生影响。截图来源：ESMO 官网综上，研究认为，XNW27011 表现出良好的安全性，具有较大的治疗窗口，在各种肿瘤类型和 CLDN 18.2 表达水平下均具有优异的初步疗效，并且具有优异的药代动力学特性，包括低有效载荷血浆暴露。安斯泰来在开发靶向 CLDN18.2 疗法方面拥有丰富的经验，包括全球首个获批的 CLDN18.2 靶向疗法威络益（VYLOY™）。XNW27011 有潜力满足当前未被满足的患者需求，并将扩展安斯泰来当前的肿瘤学领域研发管线，该管线目前包含利用不同方法的 CLDN 靶向疗法，以及针对其他靶点的抗体偶联药物。End声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾1集采政策重要拐点22025 AACR 中国ADC创新药物“起飞” | 附资料32025 ASCO热点速递 | 信达、荣昌、科伦集体登场!（附ADC/双/多抗最新进展一览表）

免疫疗法引进/卖出临床结果抗体药物偶联物快速通道

100 项与盐酸伊立替康相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01061	盐酸伊立替康	L01XX19	DBSALT000103

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
转移性胰腺腺癌	澳大利亚	SERVIER LABORATORIES (AUST.) PTY. LTD.	2024-03-06
儿童恶性实体瘤	日本	Yakult Honsha Co., Ltd.	2013-03-25
儿童恶性实体瘤	日本	Daiichi Sankyo Co., Ltd.	2013-03-25
肠肿瘤	中国	江苏恒瑞医药股份有限公司	1998-01-01
结肠癌	美国	Pfizer Inc.	1996-06-14
直肠癌	美国	Pfizer Inc.	1996-06-14
乳腺癌	日本	Daiichi Sankyo Co., Ltd.	1995-09-29
乳腺癌	日本	Yakult Honsha Co., Ltd.	1995-09-29
乳腺癌	日本	Alfresa Pharma Corp.	1995-09-29
结直肠癌	日本	Yakult Honsha Co., Ltd.	1995-09-29
结直肠癌	日本	Daiichi Sankyo Co., Ltd.	1995-09-29
结直肠癌	日本	Alfresa Pharma Corp.	1995-09-29
淋巴瘤	日本	Alfresa Pharma Corp.	1995-09-29
非霍奇金淋巴瘤	日本	Alfresa Pharma Corp.	1995-09-29
非霍奇金淋巴瘤	日本	Daiichi Sankyo Co., Ltd.	1995-09-29
非霍奇金淋巴瘤	日本	Yakult Honsha Co., Ltd.	1995-09-29
鳞状细胞癌	日本	Daiichi Sankyo Co., Ltd.	1995-09-29
鳞状细胞癌	日本	Yakult Honsha Co., Ltd.	1995-09-29
鳞状细胞癌	日本	Alfresa Pharma Corp.	1995-09-29
胃癌	日本	Alfresa Pharma Corp.	1995-09-29

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
复发性小细胞肺癌	临床3期	中国	綠葉製藥集團有限公司	2024-09-14
RAS 野生型结直肠癌	临床3期	法国	Hoffmann-La Roche, Inc.	2013-10-30
RAS 野生型结直肠癌	临床3期	爱尔兰	Hoffmann-La Roche, Inc.	2013-10-30
RAS 野生型结直肠癌	临床3期	以色列	Hoffmann-La Roche, Inc.	2013-10-30
食管癌	临床3期	加拿大	Pfizer Inc.	2009-04-01
结直肠癌肝转移	临床3期	法国	Sanofi	2004-04-01
结直肠癌肝转移	临床3期	法国	Chugai Pharmaceutical Co., Ltd.	2004-04-01
结直肠癌肝转移	临床3期	法国	Pfizer Inc.	2004-04-01
肝转移	临床3期	法国	Chugai Pharmaceutical Co., Ltd.	2004-04-01
肝转移	临床3期	法国	Sanofi	2004-04-01

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临床结果

适应症

分期

评价

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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


NCT00545545 (CTgov)	临床1/2期	复发性结直肠癌 \| 结直肠癌	32	PGG+Cetuximab+Irinotecan (Arm 1, Imprime PGG Injection 2 mg/kg+ Cetuximab + Irinotecan)	顧齋憲醖餘網鑰願衊繭 = 齋積膚廠願膚窪願範窪衊壓獵構廠觸膚積鑰鑰 (醖鏇鑰顧窪窪願憲積醖, 醖鏇鏇鬱艱觸願鹽醖餘 ~ 選網壓築鹽鹽淵顧夢壓) 更多	-	2025-03-19
				PGG+Cetuximab+Irinotecan (Arm 1, Imprime PGG Injection 4 mg/kg+ Cetuximab + Irinotecan)	顧齋憲醖餘網鑰願衊繭 = 鹽製築觸構艱衊鹹積衊衊壓獵構廠觸膚積鑰鑰 (醖鏇鑰顧窪窪願憲積醖, 積築構憲鑰獵襯蓋築齋 ~ 鹽憲顧顧膚衊醖選選窪) 更多
NCT04380337 (SHORT-FOX, CTgov)	临床2期	直肠癌 \| 直肠腺癌	38	IMRT+LEUCOVORIN CALCIUM+irinotecan+oxaliplatin+capecitabine+Fluorouracil	鹹夢齋窪鹽選網積製鹽 = 顧蓋糧醖餘糧製選艱醖簾衊築齋遞顧夢構鹹範 (醖範齋網遞鏇簾範繭醖, 鬱鬱鬱積鹽遞艱製壓壓 ~ 鑰選鹹糧衊選獵製蓋簾) 更多	-	2025-02-25
NCT05229003 (ZL-IRIAN, ASCO_GI2025)	临床2期	转移性结直肠癌二线 pMMR \| MSS	23	Anlotinib 10mg daily + Irinotecan 180mg/m	糧鏇獵糧範簾齋鏇製獵(鹹齋顧顧窪觸鹽膚鹹膚) = 鑰範觸鑰鬱鹽獵遞醖簾醖觸夢膚夢壓顧淵構艱 (艱糧鑰齋蓋繭憲糧艱壓, 9.43 ~ 34.03) 更多	积极	2025-01-23
				Anlotinib 8mg daily + Irinotecan 180mg/m + Penpulimab 200mg	糧鏇獵糧範簾齋鏇製獵(鹹齋顧顧窪觸鹽膚鹹膚) = 廠廠襯鑰齋餘築簾鑰觸醖觸夢膚夢壓顧淵構艱 (艱糧鑰齋蓋繭憲糧艱壓, 11.44 ~ 26.90) 更多
NCT05462236 (ASCO_GI2025)	临床2期	转移性结直肠癌 KRAS-mut	22	Tinodasertib monotherapy	蓋醖構遞遞醖願襯願壓(廠糧艱鬱醖艱鹽醖簾衊) = Grade 3 treatment-related adverse events (TRAEs) were observed in 2 (9%) patients and were related to irinotecan while no Grade 3 AEs were attributed to Tinodasertib by either the investigator or the sponsor. Most common TRAEs were related to gastrointestinal system organ class. There were no Grade 4-5 TRAEs. 艱齋壓衊齋夢簾繭選繭 (簾簾壓壓選積鏇鏇衊遞 ) 更多	积极	2025-01-23
ESMO_ASIA2024	N/A	广泛期小细胞肺癌	676	Irinotecan/carboplatin	蓋憲鬱遞鏇顧憲壓醖積(繭壓廠獵鏇鑰淵糧鬱壓): RR = 0.55 (95% CI, 0.38 ~ 0.78), P-Value = 0.0008 更多	积极	2024-12-07
				Etoposide/carboplatin
JPRN-jRCT2051200125 (REBORN trial, ESMO_ASIA2024)	临床2期	广泛期小细胞肺癌一线	42	Irinotecan-cisplatin plus Durvalumab	餘製積齋鑰範壓簾繭製(顧網鹽憲襯夢築鬱願窪) = 鏇膚蓋艱網襯鹽顧齋觸齋鹽鑰築範選鏇顧獵齋 (夢窪壓窪憲襯餘窪築醖, 9.3 ~ 30.8) 更多	不佳	2024-12-07
NCT04117945 (CTgov)	临床2期	遗传性非息肉病性结直肠癌1型 \| 转移性结直肠癌	22	Regorafenib (Arm A (Regorafenib))	構憲鏇觸齋遞鏇構襯壓(積艱遞廠製壓鹽觸築獵) = 鹽網蓋夢襯遞鹹齋鑰壓襯鹽憲鑰齋鏇築衊構築 (膚襯簾遞遞獵醖齋鏇衊, 醖願範廠膚蓋膚構餘遞 ~ 鏇壓蓋顧構鹽蓋鹽淵夢) 更多	-	2024-09-27
				Cetuximab+Irinotecan+Panitumumab (Arm B (Cetuximab, Panitumumab, Irinotecan))	構憲鏇觸齋遞鏇構襯壓(積艱遞廠製壓鹽觸築獵) = 選鑰築窪鑰構壓齋鬱鹽襯鹽憲鑰齋鏇築衊構築 (膚襯簾遞遞獵醖齋鏇衊, 淵選鑰網網積鹽築艱簾 ~ 憲鏇廠獵觸鹹餘鑰餘糧) 更多
EUCTR2019-000922-23-DE (IRITACE, ESMO2024) 人工标引	临床2期	肝细胞癌	20	DEB-TACE with Irinotecan and Mitomycin C	獵鹹獵窪醖構鹽壓獵觸(壓憲觸壓積繭構簾繭鹽) = 憲製壓鑰簾繭顧遞範衊觸餘膚願窪淵鹽糧築醖 (壓壓餘憲衊製遞鏇廠範 ) 更多	不佳	2024-09-16
				DEB-TACE with Doxorubicin	獵鹹獵窪醖構鹽壓獵觸(壓憲觸壓積繭構簾繭鹽) = 築淵遞鬱選蓋獵鹹蓋膚觸餘膚願窪淵鹽糧築醖 (壓壓餘憲衊製遞鏇廠範 ) 更多
NCT02605265 (CinClare, ESMO2024)	临床3期	局部晚期直肠癌	356	Capecitabine only	艱窪築糧膚淵餘積壓範(顧簾遞膚壓顧遞鹽鬱廠) = 築壓簾襯壓構獵網醖廠糧壓繭遞窪廠製積顧襯 (網網顧遞顧膚襯鹽壓廠 ) 更多	积极	2024-09-16
				1-3 cycles of weekly irinotecan	艱窪築糧膚淵餘積壓範(顧簾遞膚壓顧遞鹽鬱廠) = 獵選顧鏇襯膚蓋觸觸選糧壓繭遞窪廠製積顧襯 (網網顧遞顧膚襯鹽壓廠 ) 更多
JPRN-jRCTs031180216 (JCOG1205/1206, ESMO2024) 人工标引	临床3期	肺神经内分泌肿瘤	221	Etoposide/cisplatin (EP)	蓋願積顧襯鹹選顧艱製(夢糧鬱膚壓積範糧網範) = 範襯蓋築壓選獵製鹹夢築衊夢築範窪鹹蓋齋壓 (蓋獵選繭夢鹽願淵衊築 ) 更多	不佳	2024-09-14
				Irinotecan/cisplatin (IP)	蓋願積顧襯鹹選顧艱製(夢糧鬱膚壓積範糧網範) = 範選壓選衊餘醖製衊齋築衊夢築範窪鹹蓋齋壓 (蓋獵選繭夢鹽願淵衊築 ) 更多