A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects With FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC).
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States.
Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years .
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

开始日期2025-11-21

申办/合作机构

AbbVie, Inc.

NCT07059845

/ Recruiting临床2期

A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Mirvetuximab Soravtansine in Subjects With Ovarian Cancer

Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay.
Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 2 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. Approximately 320 participants will be enrolled in the study at 100 sites around the world.
Participants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused Bev alone. The total study duration will be approximately 40 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

开始日期2025-11-13

申办/合作机构

AbbVie, Inc.

NCT06682988

/ Recruiting临床2期

A Randomized Phase 2, Open-label Study of Mirvetuximab Soravtansine in Patients With Platinum-resistant Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-alpha Expression Testing 2 Schedules of Administration for Dose Optimization, With a Separate Cohort to Determine Starting Dose in Patients With Moderate Hepatic Impairment

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα).
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide.
The total study duration will be approximately 24 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

开始日期2025-05-28

申办/合作机构

AbbVie, Inc.

100 项与索米妥昔单抗相关的临床结果

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100 项与索米妥昔单抗相关的转化医学

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100 项与索米妥昔单抗相关的专利（医药）

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147

项与索米妥昔单抗相关的文献（医药）

2026-04-01·Gynecologic Oncology Reports

Characterizing therapeutic target antigen expression in anaplastic carcinoma of the ovary

Article

作者: Sonoda, Yukio ; Tarney, Christopher ; Sullivan, Mackenzie W ; Makker, Vicky ; Kanbergs, Alexa N ; Selenica, Pier ; Weigelt, Britta ; O'Cearbhaill, Roisín E ; Green, Hunter ; Long, Kara C ; Mueller, Jennifer J ; Grisham, Rachel N ; Gill, Kaitlyn ; Jungbluth, Achim A ; Chui, M Herman ; Abu-Rustum, Nadeem R

Objective:

Novel treatment strategies are needed for patients with anaplastic carcinoma of the ovary given the high incidence of chemoresistance to conventional systemic therapies. Here we sought to evaluate HER2, FOLR1, TROP2, and mismatch repair protein expression as well as the tumor mutational burden of anaplastic carcinoma of the ovary.

Methods:

We retrospectively identified a total of 9 anaplastic ovarian carcinomas in institutional databases from 2013 to 2023, including one case from a collaborating institution. Cases with adequate tissue available underwent immunohistochemical analysis for HER2, FOLR1, TROP2, and mismatch repair proteins MLH1, MSH2, MSH6, and PMS2. Tumor mutational burden was obtained from tumor-normal panel sequencing.

Results:

Anaplastic carcinoma of the ovary demonstrated low or absent expression of FOLR1, HER2, and TROP2 protein. FOLR1 expression in the two cases was weak and below currently used clinical cutoffs for mirvetuximab soravtansine eligibility. HER2 expression was low in the two anaplastic carcinomas (1-2+). TROP2 expression was low in one case (H-score of 60) and negative in the other five. All cases were mismatch repair proficient by immunohistochemistry and had low tumor mutational burden (median, 3.3 mut/Mb; range, 0.8-6.9).

Conclusion:

Only a subset of anaplastic carcinomas of the ovary express targetable tumor antigens at low levels, suggesting that these may have limited benefit from antibody-drug conjugates. Likewise, due to mismatch repair proficiency and low tumor mutational burden, immunotherapy is unlikely to be effective in this rare disease.

2026-03-01·DIAGNOSTIC CYTOPATHOLOGY

Detecting FR ‐⍺ Expression Level in Cytology Effusion Specimens From Ovarian Cancer and Comparing It With Tissue Specimens

Article

作者: Siqian Huang ; Sishi Bai ; Xiaofei Yu ; Yadan Ma ; Baizhou Li ; Xiaohong Duan

ABSTRACT:

Background:

Folate receptor‐⍺ (FR‐⍺) is an attractive target for targeted therapy. Mirvetuximab soravtansine (MIRV) has been approved by the United States Food and Drug Administration (FDA) for treating adult patients with FR‐⍺ positive, platinum‐resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Therefore, identifying and detecting FR‐⍺ has become an essential part of precision medicine. This study aimed to evaluate the feasibility of detecting FR‐⍺ protein expression in serous cavity effusions using cell blocks (CBs) and compare the results with surgical pathology biopsy or resection specimens. Furthermore, we investigated potential variations in FR‐⍺ expression pre‐ and post‐chemotherapy.

Methods:

Immunohistochemical (IHC) staining of FR‐⍺ was performed on the serous cavity effusion specimens from 35 patients with epithelial ovarian cancer, along with matched surgical pathological (SP) biopsy or resection specimens, following the manufacturer's guidelines for IHC analysis.

Results:

Positive staining was observed in 30 (85.7%) and 32 (91.4%) serous cavity effusion CB and tissue samples, respectively. A total of 31 (88.5%) tissue and 28 (80%) effusion CB samples exhibited moderate‐to‐strong FR‐⍺ expression in at least 25% of tumor cells. A cutoff of 25% for FR‐⍺ expression positivity was used to demonstrate high concordance (96.4%) between cytology CBs and tissue specimens. We recommend a cutoff of 75% viable tumor cells with moderate‐to‐strong membrane staining as “positive” in CBs for greater reliability, which aligns with FDA‐approved criteria. A reasonable consistency was observed in FR‐⍺ expression between the pre‐treatment serous cavity effusion CB specimens and the new biopsy specimens obtained after multiline treatment.

Conclusion:

We demonstrated that serous effusion CB specimens may be effective for FR‐⍺ biomarker detection; FR‐⍺ maintains stable expression pre‐ and post‐chemotherapy, and patients can benefit from MIRV.

2026-03-01·Journal of Pathology Clinical Research

Folate receptor alpha ( FRα ) expression in tubo‐ovarian and endometrial tumors: a study of 923 cases

Article

作者: Špůrková, Zuzana ; Kendall Bártů, Michaela ; Laco, Jan ; Dundr, Pavel ; Fabian, Pavel ; Cibula, David ; Vránková, Romana ; Švajdler, Marián ; Méhes, Gábor ; Hausnerová, Jitka ; Töltési, Isabela ; Frühauf, Filip ; Němejcová, Kristýna ; Matěj, Radoslav

Abstract:

Folate receptor alpha (FRα) is a promising therapeutic target due to its high expression in several tumor types and its rare expression in healthy tissue. Recently, the antibody‐drug conjugate mirvetuximab soravtansine has been approved for treatment of advanced platinum‐resistant high‐grade serous carcinoma (HGSC). Immunohistochemical expression of FRα has been extensively studied in HGSC, but most studies conducted before the clinical studies targeting FRα used variable antibodies and scoring criteria, which makes comparison of older literature data with recent studies difficult. Moreover, the data regarding its expression in other types of ovarian and other female genital tract tumors are limited or absent. In our study, we focused on immunohistochemical expression in 923 tubo‐ovarian and endometrial tumors (assessed on tissue microarrays), using standardized scoring criteria and the VENTANA FOLR1 CDx assay. The results of our study showed the highest FRα expression in serous carcinomas, specifically HGSC (45% positive cases), followed by low‐grade serous carcinoma (25%), endometrial serous carcinoma (11%), and serous borderline tumor (10%). Endometrioid and clear cell ovarian carcinomas showed rare positivity (2% and 1%, respectively). All other tumors examined were negative, including mucinous ovarian tumors, sex cord‐stromal tumors, endometrial endometrioid carcinomas, undifferentiated and dedifferentiated carcinomas, and endometrial clear cell carcinomas. In conclusion, these results confirm that FRα expression in HGSC and LGSC reaches similar values compared to published data, and is present in a minority of endometrial serous carcinomas. In other ovarian and endometrial tumors examined, FRα expression is absent or rare.

911

项与索米妥昔单抗相关的新闻（医药）

2026-05-13

·今日头条

华东医药HDM2017联合呋喹替尼获批临床，卡位消化道ADC赛道

ADC赛道内卷浪潮之下，差异化靶点与联合治疗已然成为药企破局的核心路径。5月13日，华东医药（000963.SZ）发布官方公告，全资子公司中美华东研发的1类生物新药注射用HDM2017，顺利获得NMPA临床试验批准，将开展联合呋喹替尼治疗晚期结直肠癌的临床研究。图片来源：华东医药公告作为靶向CDH17的原创ADC药物，HDM2017早已完成中美双临床获批、斩获FDA三项孤儿药资格，此番联合用药落地，既是产品研发进程的关键跨越，也是华东医药深耕消化道肿瘤、构筑ADC研发生态的重要一步。依托抗血管生成与靶向杀伤的双重协同机制，叠加公司扎实的基本面与全产业链ADC布局，华东医药正凭借差异化打法，在拥挤的创新药赛道中走出自己的成长曲线。研发提速 5月12日，中美华东收到NMPA核发的《药物临床试验批准通知书》（通知书编号2026LP01465），正式允许HDM2017联合呋喹替尼用于晚期结直肠癌适应症临床试验。这款药物为中美华东研发、拥有全球完整知识产权的1类生物新药，靶向消化道肿瘤高特异靶点CDH17。梳理研发时间线，HDM2017推进节奏十分紧凑。2025年7月正式递交IND申请，同年9月实现中美双地单药临床获批；2026年3月，产品拿下FDA授予的胆道癌、胃癌、胰腺癌三项孤儿药资格，享受美国市场税收减免、注册优惠及7年市场独占权益。时隔两个月，联合用药适应症再获临床批件，研发落地效率凸显公司扎实的创新药申报与研发实力。从用药逻辑来看，此次组合具备极强的协同属性。HDM2017作为CDH17 ADC，依靠单克隆抗体精准锚定肿瘤细胞，释放毒素实现定向杀伤，同时具备旁观者效应，可覆盖肿瘤异质性病灶；呋喹替尼作为成熟VEGFR抑制剂，主打抑制肿瘤新生血管生成、重塑肿瘤微环境。二者联用形成“靶向灭杀+断供营养”的闭环，能够有效突破晚期结直肠癌现有治疗瓶颈，弥补临床未满足需求，也契合当下实体瘤联合治疗的行业主流趋势。管线成型深耕医药产业多年，华东医药已搭建医药工业、医药商业、医美、工业微生物四大业务板块，多元布局筑牢经营基本盘。截至2026年5月13日收盘，华东医药报33.27元/股，日跌0.86%，总市值583亿元；股价整体表现平稳，市值具备充足安全边际，业绩增长韧性持续凸显。财务数据显示，2025年华东医药实现营收436.12亿元，同比增长4.07%，归母净利润稳定维持高位；2026年一季度延续增长态势，归母净利润同比增幅超9%，扣非利润创下同期新高，明确进入业绩向上拐点。创新转型成为华东医药近年发展核心主线，医药工业作为创新核心载体，增长动能持续释放。 2025年华东医药创新产品收入大幅攀升，同比增幅超64%，占工业营收比重稳步提升，2026年一季度创新药收入占比突破20%，正式从业务补充成长为核心增长引擎。研发投入层面，华东医药持续加码创新药布局，高额研发支出为ADC、小分子靶向药等管线迭代提供坚实支撑。在备受市场关注的ADC领域，华东医药早已搭建起全球化研发生态圈，通过参控股荃信生物、诺灵生物、珲达生物等企业，叠加与德国Heidelberg Pharma深度合作，完成抗体、连接子、毒素三大核心要素全产业链自主可控。目前华东医药肿瘤管线梯度清晰，索米妥昔单抗已实现商业化上市，马来酸美凡厄替尼片（曾用名：迈华替尼片）获批上市，HDM2017、HDM2012、HDM2020等多款ADC产品密集推进临床，形成“上市-临床”多层次管线矩阵。聚焦HDM2017产品本身，技术设计具备鲜明差异化优势。药物采用抗CDH17单抗搭配可裂解连接子，偶联拓扑异构酶I抑制剂，标准DAR值维持在4的最优区间，平衡药效强度与用药安全性。从靶点特性来看，CDH17在正常人体组织中仅局限于肠上皮表达，却在结直肠癌、胃癌、胰腺癌等消化道肿瘤中高比例过表达，超90%的结直肠癌患者存在靶点富集，特异性强、脱靶风险低，是天然的理想ADC靶点。临床前研究数据显示，HDM2017在多款消化道肿瘤模型中抗肿瘤效果突出，动物试验耐受性良好，安全性与成药性得到验证。凭借靶点稀缺性、技术成熟度以及联合用药创新布局，产品稳居国内CDH17 ADC第一梯队。赛道机遇全球ADC行业正处在爆发式增长周期，赛道规模连年扩容，2030年全球市场规模有望突破647亿美元，国内市场增速更是远超全球平均水平，国产替代浪潮势不可挡。相较于HER2、TROP2等极度内卷的热门靶点，CDH17聚焦消化道肿瘤蓝海领域，目前国内仅有十余家企业布局临床阶段，竞争格局相对温和。参考翰森制药、乐普生物等同靶点企业超10亿美元级海外授权交易，HDM2017凭借全球知识产权与FDA孤儿药加持，未来出海授权与商业化想象空间充足。从市场需求来看，2022年全球新发结直肠癌病例约192.6万例，胃癌、胰腺癌发病率居高不下，晚期患者二线后治疗手段匮乏，临床需求长期未被满足。随着国内医保对创新药扶持力度加大、商业化终端持续扩容，叠加华东医药成熟的学术推广与销售团队，HDM2017一旦顺利上市，有望快速实现市场放量，撬动百亿级消化道肿瘤市场空间。行业趋势层面，靶点多元化、治疗联合化、技术自研化成为ADC发展三大主线。消化道肿瘤精准治疗崛起，ADC联合抗血管、免疫药物已成临床研发主流方向，华东医药HDM2017联合呋喹替尼的布局，精准踩中行业发展风口，先发优势显著。机遇背后，潜在风险同样值得警惕。ADC药物天然具备研发投入高、周期跨度长、临床失败率偏高的行业特性，HDM2017当前仍处在临床早期阶段，联合用药方案的剂量耐受性、安全性及临床疗效，都有待后续多期临床试验逐步验证。放眼整个赛道，CDH17靶点已有多家头部药企抢先布局、同步推进管线，未来谁能拿出更优的临床数据、更快的研发进度，才能构筑起真正的差异化竞争壁垒。即便后续研发顺利实现上市，产品还要直面医保谈判常态化降价、创新药集采落地带来的盈利挤压压力。同时华东医药也明确提示，此次临床获批不会对公司短期经营业绩形成实质拉动，创新管线价值兑现仍需要较长时间沉淀。从单药临床获批到联合用药落地，华东医药HDM2017的稳步推进，是华东医药创新转型成果的真实缩影。在ADC赛道同质化内卷的当下，华东医药锚定CDH17优质靶点，依托全产业链技术布局、成熟的管线梯队与稳固的经营基本面，走出了一条差异化研发之路。消化道肿瘤庞大的患者基数、未被满足的临床需求，叠加全球ADC行业的高景气度，为HDM2017赋予了充足的成长想象空间。虽然临床研发周期漫长、赛道竞争与商业化挑战客观存在，但凭借先发布局、联合治疗创新与全球化知识产权优势，HDM2017有望成长为消化道肿瘤领域潜力大单品，也将持续夯实华东医药在国内ADC行业的第一梯队地位。后续临床数据读出、管线推进进度，将成为观察公司创新价值兑现的核心风向标。敬告读者：本文基于公开资料信息或受访者提供的相关内容撰写，文章作者不保证相关信息资料的完整性和准确性。无论何种情况下，本文内容均不构成投资建议。市场有风险，投资需谨慎！未经许可不得转载、抄袭！

2026-05-13

·BioPlus

盘点25个双载荷ADC项目：结构、药效与毒理数据（上篇）

作者：琉璃韵因篇幅有限，内容将分两篇刊出。上篇覆盖12个项目，包括来自Celltrion Pharm、APITBIO、康威生物、新蕴达生物、Sutro、宜联生物、道尔等机构的双载荷ADC项目；下篇将整理余下的13个项目，包括来自齐鲁、拓济、百奥奕图、Araris、爱科瑞思、映恩、三优、多禧、普灵、Hummingbird、亲和力及Baylink等机构的项目。前言近年来，双载荷ADC逐渐从概念验证走向更系统的分子设计阶段。双载荷ADC的核心思路在于通过不同毒素机制、不同旁观者效应或不同药物释放特征的组合，尝试提高肿瘤细胞杀伤覆盖度，并在异质性肿瘤或耐药场景中提供新的解决方案。从已披露项目看，当前双载荷ADC的载荷组合主要集中在Topoisomerase I抑制剂+微管抑制剂、Topoisomerase I抑制剂+其他细胞毒药物，以及部分非传统payload组合。以下整理了部分已披露双载荷ADC项目的结构设计、体内药效及毒理数据。其中，毒理数据值得关注，可反映双载荷设计在安全窗口上的真实挑战。表1 项目概览列表项目数据项目1——CPTH-08 （Celltrion）结构：CTPH-08 AD²C 平台的核心在于其独特的分支型可裂解连接子。靶点为FRα同时偶联两种机制互补的细胞毒性载药：MMAE+ Payload X，DAR值为2+2。体内药效：FRα低表达模型 (OVCAR3)：在同等剂量（2 mg/kg）下，CTPH-08展现出与Elahere相当的肿瘤抑制率（TGI），这说明其保底能力是完全在线的。FRα高表达模型 (IGROV1)：在4 mg/kg和8 mg/kg的剂量下，CTPH-08的抗肿瘤活性显著优于同剂量的Elahere，实现了更深度的肿瘤退缩。毒理表现：在ICR小鼠的单次静脉注射（IV）给药研究中：测试剂量推到了60, 80, 100 mg/kg。无动物死亡，未观察到治疗相关的临床症状；整个研究期间体重稳定；血液学和临床生化指标无显著异常；大体病理学也没有发现异常。项目2——CTPH-03 （Celltrion Pharm）结构：靶点为TROP2，采用MMAE与Payload X的双重协同策略，总DAR为2+2。体内药效：在TROP2高/低表达模型中均表现出优于Trodelvy的抗肿瘤活性。对照组为 Trodelvy (10 mg/kg) 和 Datroway (10 mg/kg)，而 CTPH-03 的给药剂量梯度为 2.5 mg/kg、5 mg/kg 和 10 mg/kg 。相较于 Trodelvy 和Datroway，CTPH-03 展现出了更强的肿瘤生长抑制能力。毒理表现 (Tox)：在ICR小鼠中MTD > 100 mg/kg，无显著血液学毒性。项目3——YB-811（Ymmunobio AG）结构：采用的是靶向 NPTXR 的人源化单克隆IgG1抗体。其体外结合亲和力极高，KD约为 0.2 nM 。载荷组合为：MMAF + Exatecan，DAR值4+4 体内药效：给药方案为每周一次腹腔注射（i.p.）。在T1016肿瘤模型中，10 mg/kg的 YB-811诱导了肿瘤的完全消退。膀胱癌PDX模型中10 mg/kg 的 YB-811 同样表现出显著的抗肿瘤活性。项目4——Ab612（APITBIO）结构：靶点为CD171 (L1CAM) ，采用的是优化的 IgG1 单克隆抗体。载荷：MMAE+Exatecan。该 ADC 技术平台支持 DAR2、DAR4 或 DAR8 的构建。体内药效：在动物模型的数据上，Ab612-ADC 在3 mpk (mg/kg)的低剂量下，即可实现100% 的肿瘤消退。项目5——CAN017（康威）结构：同时靶向CLDN18.2 /PD-L1，载荷：MMAE + Exatecan，DAR值:2+2。体内药效：小鼠结肠癌 CDX 模型 (CLDN18.2+/PD-L1+)、人胰腺癌 CDX 模型 (CLDN18.2+) 以及人胃癌 CDX 模型中，CAN017 展现出的肿瘤生长抑制效果，均显著优于其裸双抗、单载荷 ADC（CAN3609D（MMAE）或CAN3610D （Exatecan）以及这两种单载荷 ADC 的联用。毒理数据：单次给药耐受性高达70 mg/kg，在给药后，小鼠的体重曲线保持平稳，没有出现显著下降。PK 分析显示其在血浆中具有出色的稳定性，游离毒素处于定量下限 (BQL) 以下。其整体治疗窗口大于23倍。项目6——CAN016 （康威）结构：CAN016的靶点为HER2，载荷为：MMAE+Exatecan，DAR值为2+2。体内药效：CAN016在初始肿瘤体积已达到约 1000 mm³ 的 NCI-N87（高表达 HER2）和 JIMT-1（低表达 HER2）模型中，CAN016 均展现了抗肿瘤效果，优于T-DXd。在T-DXd耐药的HCC1954 CDX模型中，单剂量的 CAN016 显示出持续的药效。毒理学数据：在GLP 食蟹猴毒理学研究中，确定的HNSTD为 20 mg/kg。项目7——OBI-221（OBI）结构：靶点为MET/HER3,载荷为MMAE+Exatecan，DAR值2+8 体内药效：无论是在靶点低、中还是高表达的模型中，OBI-221 均展现出抗肿瘤活性。即使在MET和HER3表达不对称的肿瘤模型中，OBI-221的体内疗效依然显著优于单靶点的基准 ADC 药物。项目8——XYD-8006（昆山新蕴达）结构：靶点为ADAM9，抗体亚型采用的是人源化的IgG1。载荷：MMAE + Exatecan。DAR值：2+6。体内药效：XYD-8006 展现了强大的杀伤力，并且能克服靶点表达丰度的限制：中高表达模型 (肺癌 Calu-3)：XYD-8006的TGI达到了 89.46%。显著优于单载药的XYD-8006-EXD DAR4 (54.72%) 。中低表达模型 (喉癌 Detroit-562)：XYD-8006的TGI为 81.69%。低表达模型 (结直肠癌 SW48)：XYD-8006 的 TGI 达到了85.20%。 PK数据：XYD-8006 在人类和食蟹猴的血浆中均表现出极佳的稳定性。在长达21天的测试期内，几乎检测不到游离的Exatecan或MMAE毒素脱落。项目9：STRO227（Sutro）结构：靶点为PTK7，载荷为MMAE+Exatecan，DAR值：2+8 体内药效数据：在乳腺癌CDX模型中，STRO-227 展现了剂量依赖性抗肿瘤活性。更重要的是，在同等剂量下，STRO-227 的疗效显著优于单一载荷 MMAE 或 Exatecan 的对照 ADC。在TNBC和卵巢癌的 PDX 模型中，2-3 mg/kg 剂量下即观察到显著的肿瘤抑制。NSCLC PDX测试：在包含腺癌和鳞癌的非小细胞肺癌 PDX 模型中，STRO-227的ORR为 57% ，DCR为76% 食蟹猴中多次静脉给药 (25 mg/kg, Q3W x 2) 后，STRO-227 展现出优秀的 PK 特征。系统清除率低，终末半衰期长（约10.5天） STRO-227的HNSTD为25 mg/kg，25 mg/kg剂量下未观察到显著体重下降。项目10：Sutro's dpADC（Sutro）结构：靶点为HER2，载荷组合：Exatecan+MTI，DAR值8+4。体内药效：在体内的CDX 模型中，该 dpADC 的抗肿瘤活性均显著优于Enhertu。超越单载药与联用：在卵巢癌模型中，dpADC 诱导的肿瘤抑制和生长延迟不仅优于单一载荷的 ADC，甚至显著优于两种单载药荷 ADC 的联合给药（尽管联合给药组的总给药剂量达到了 20mg/kg，是 dpADC 单药 10mg/kg 的两倍）。克服Enhertu 耐药：在 Enhertu 耐药胃癌模型和卵巢癌模型中，dpADC 均能引发显著的肿瘤退缩，大幅延长无进展生存期 (EFS)。非人灵长类 (NHP) 毒理数据：在食蟹猴中进行的毒理学分析（12.5 mg/kg IV，第1天和第22天，Q3Wx2）显示， HNSTD 为12.5 mg/kg。项目11——YL413（宜联生物）结构：靶点为HER2，载荷为Top1+MTi，DAR值为7+1 体内药效：在 HER2 高表达的胃癌模型 (NCI-N87 CDX) 和 HER2 中表达的乳腺癌模型 (JIMT-1 CDX) 中，YL413 的肿瘤抑制效果均优于 Enhertu。克服Enhertu耐药：在经过Enhertu 预处理产生耐药的 PDX 模型中，以及对 Enhertu 明确耐药的 NCI-N87 (CDX) 模型中， YL413 显示出疗效。循环稳定性：在猴单次静脉注射剂量达 24 mg/kg 的情况下，表现出良好的耐受性。项目12——DR319（道尔生物）结构：靶点为Trop2/Nectin4，载荷为Top1+MTi，DAR值为4+2 体内药效：在 HT1376 模型中，DR319-DP 仅用1/8 的剂量 (1 mg/kg)，就实现了与 PADCEV (8 mg/kg) 或 PADCEV+SKB264 物理联用组 (4+4 mg/kg) 相当甚至更优的抗肿瘤疗效。在食蟹猴体内的初步毒理和药代动力学 (PK) 研究中，DR319-DP 展现出了良好的 PK 谱和安全性特征。小结双载荷ADC的设计重点已经不只是简单叠加载荷，而是围绕载荷机制互补、DAR比例、连接子稳定性和靶点内吞效率进行系统优化。相比药效，毒理数据更值得关注。部分分子已披露小鼠高剂量耐受数据，剂量最高推进至70、100mg/kg以上；也有项目披露了食蟹猴毒理结果，HNSTD达到12.5–20mg/kg。整体来看，双载荷设计关键取决于血浆稳定性、游离payload暴露、释放节奏以及靶点依赖性递送效率。近期会议点击图片，跳转会议详情参会报名 1. 免费审核门票（仅限生物医药投资人、Biotech/药企、临床/院校科学家，不含餐，不含私董会）免费门票获取（微信朋友圈集21个赞，报名时上传截图，可获取门票） 2. 会议门票500元（含两天公开会议，含5月22日午餐，不含私董会）； 3. 晚宴门票2000元（含两天公开会议，含5月21日晚餐，5月22日午餐，不含私董会）

抗体药物偶联物临床研究

2026-05-13

·分析测试百科网

Rufinamide,卢非酰胺,106308-44-5

MCE 的所有产品仅用作科学研究或药证申报，我们不为任何个人用途提供产品和服务。RufinamideMCE 国际站：Rufinamide品牌：MedChemExpress (MCE)货号：HY-A0042CAS：106308-44-5中文名称：卢非酰胺Synonyms：卢非酰胺; CGP 33101; E 2080; RUF 331纯度：99.88%存储条件：Powder -20°C 3 years 4°C 2 years In solvent -80°C 2 years -20°C 1 year运输条件：美国大陆的室温；其他地方可能有所不同。产品活性：Rufinamide (E 2080; CGP 33101; RUF 331)是新型镇痫化合物，可用于 Lennox-Gastaut 综合症的的研究。生物活性：Rufinamide(E 2080; CGP 33101; RUF 331) 是一种新型抗癫痫药，在结构上不同于其他抗癫痫药，被批准用于 Lennox-Gastaut 综合征 (LGS) 的辅助治疗。 IC50 值：目标：体外：体内：Rufinamide 和阿米替林减轻损伤引起的机械异常性疼痛 4 小时（最大效果：0.10 ± 0.03 g（平均值 ± SD）至 1.99 ± 0.26 g 用于 rufinamide 和 0.25 ± 0.22 g 至 1.92 ± 0.85 g（对于阿米替林）在小鼠中 [1]。口服卢非酰胺抑制戊四氮诱导的小鼠癫痫发作 (ED(50) 45.8 mg/kg) 而不是大鼠，并且对小鼠 (ED(50) 23.9 mg/kg) 和大鼠 (ED(50) ) 6.1 毫克/千克) [2]。腹膜内注射卢非酰胺抑制戊四唑、荷包牡丹碱和印防己毒素诱导的小鼠阵挛（ED(50) 分别为 54.0、50.5 和 76.3 mg/kg）。临床试验：评估 SYN-111（卢非酰胺）对广泛性焦虑症 (GAD) 患者疗效的探索性研究。阶段2热销产品：Amivantamab | Temozolomide | Aldosterone | Mirvetuximab soravtansine | Pexidartinib | Prostaglandin E2 | Pembrolizumab | DAPT | Pilocarpine (Hydrochloride) | IbrutinibTrending products：Recombinant Proteins | Natural Products | Fluorescent Dye | PROTAC | Oligonucleotides参考文献：[1]. Suter MR, Kirschmann G, Laedermann CJ, Rufinamide attenuates mechanical allodynia in a model of neuropathic pain in the mouse and stabilizes voltage-gated sodium channel inactivated state. Anesthesiology. 2013 Jan;118(1):160-72. [2]. White HS, Franklin MR, Kupferberg HJ, The anticonvulsant profile of rufinamide (CGP 33101) in rodent seizure models. Epilepsia. 2008 Jul;49(7):1213-20.品牌介绍:• MCE (MedChemExpress) 拥有200 多种全球独家化合物库，我们致力于为全球科研客户提供前沿最全的高品质小分子活性化合物；• 50,000 多种高选择性抑制剂、激动剂涉及各热门信号通路及疾病领域；• 产品种类涵盖各种重组蛋白，多肽，常用试剂盒，更有 PROTAC、ADC 等特色产品，广泛应用于新药研发、生命科学等科研项目；• 提供虚拟筛选，离子通道筛选，代谢组学分析检测分析，药物筛选等专业技术服务；• 设有专业的实验中心和严格的质控、验证体系；• 提供 LC/MS、NMR、HPLC、手性分析、元素分析等各项质检报告，确保产品的高纯度、高品质；• 产品的生物活性多经各国客户实验验证；• Nature, Cell, Science 等多种顶级期刊及制药专利收录了MCE客户的科研成果；• 专业团队跟踪最新的制药及生命科学研究进展，为您提供全球最新的活性化合物；• 与世界各大制药公司及知名科研机构建立了长期的合作。

100 项与索米妥昔单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10954	索米妥昔单抗	-	DB12489

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
铂敏感性卵巢上皮癌	加拿大	AbbVie, Inc.	2025-08-01
输卵管癌	英国	AbbVie Ltd.	2025-07-24
卵巢癌	英国	AbbVie Ltd.	2025-07-24
原发性腹膜癌	英国	AbbVie Ltd.	2025-07-24
叶酸受体α 阳性铂类耐药的卵巢上皮癌	美国	ImmunoGen, Inc.	2022-11-14
叶酸受体α阳性铂类耐药的输卵管癌	美国	ImmunoGen, Inc.	2022-11-14
叶酸受体α阳性铂类耐药的原发性腹膜癌	美国	ImmunoGen, Inc.	2022-11-14
铂耐药上皮性卵巢癌	美国	ImmunoGen, Inc.	2022-11-14
铂耐药性输卵管癌	美国	ImmunoGen, Inc.	2022-11-14
铂类耐药性原发性腹膜癌	美国	ImmunoGen, Inc.	2022-11-14

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
叶酸受体α阳性铂类耐药性卵巢癌	申请上市	日本	Takeda Pharmaceuticals U.S.A., Inc.	2026-01-30
肿瘤	申请上市	加拿大	AbbVie, Inc.	2025-03-01
铂敏感性输卵管癌	临床3期	美国	AbbVie, Inc.	2023-03-15
铂敏感性输卵管癌	临床3期	中国	AbbVie, Inc.	2023-03-15
铂敏感性输卵管癌	临床3期	日本	AbbVie, Inc.	2023-03-15
铂敏感性输卵管癌	临床3期	阿根廷	AbbVie, Inc.	2023-03-15
铂敏感性输卵管癌	临床3期	澳大利亚	AbbVie, Inc.	2023-03-15
铂敏感性输卵管癌	临床3期	比利时	AbbVie, Inc.	2023-03-15
铂敏感性输卵管癌	临床3期	巴西	AbbVie, Inc.	2023-03-15
铂敏感性输卵管癌	临床3期	保加利亚	AbbVie, Inc.	2023-03-15

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临床结果

适应症

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


ESGO2026	N/A	铂耐药性卵巢癌 folate receptor alpha (FRα)-positive	22	Mirvetuximab Soravtansine (MV)	繭壓鏇製鬱簾膚鬱繭獵(襯膚餘網構範蓋範顧襯) = 糧衊醖膚遞衊構鏇襯淵膚範糧顧襯齋膚製膚鬱 (簾憲廠繭鏇網獵襯鬱觸 ) 更多	积极	2026-02-28
NCT05041257 (PICCOLO, CTgov)	临床2期	铂敏感性卵巢上皮癌 \| 铂类耐药性原发性腹膜癌 \| 腹膜癌 ... 更多	79	Mirvetuximab soravtansine	餘獵鬱鹽繭醖遞觸鏇範 = 齋觸網憲壓製顧網構鏇窪顧糧製窪遞窪觸艱製 (構範醖鬱鹽製夢製獵憲, 範餘窪繭繭製鹹網鹽製 ~ 衊鑰淵膚壓鏇糧構範積) 更多	-	2026-01-09
NCT04209855 (MIRASOL, ESMO2025) 人工标引	临床3期	叶酸受体α 阳性铂类耐药的卵巢上皮癌 Folate receptor alpha Positive	453	Mirvetuximab soravtansine (MIRV)	鏇壓鹽顧製鑰繭糧憲衊(積築鏇範觸繭齋蓋鏇獵) = 艱鏇襯鹹齋獵觸觸醖願範簾窪願憲遞鹽構襯選 (觸艱窪範網鏇餘顧選遞, 4.3 ~ 5.9) 更多	积极	2025-10-17
NCT04209855 (MIRASOL, ESMO2025) 人工标引	临床3期	叶酸受体α 阳性铂类耐药的卵巢上皮癌 Folate receptor alpha Positive	453	Investigator’s choice chemotherapy (ICC)	鏇壓鹽顧製鑰繭糧憲衊(積築鏇範觸繭齋蓋鏇獵) = 積夢夢顧獵鹽鹹獵廠鏇範簾窪願憲遞鹽構襯選 (觸艱窪範網鏇餘顧選遞, 2.9 ~ 4.5) 更多	积极	2025-10-17
NCT05041257 (PICCOLO, ESMO_TAT Asia2025) 人工标引	临床2期	铂敏感性卵巢癌 FRα-positive	38	Mirvetuximab soravtansine-gynx (MIRV) 6 mg/kg (HRD-positive)	鏇襯鬱觸膚鏇鑰顧顧範(蓋齋衊構構膚壓獵淵憲) = 願觸衊廠鬱夢餘廠餘簾窪鏇鬱顧繭餘衊憲選壓 (廠築壓網遞鏇憲夢鹹築 ) 更多	积极	2025-06-01
NCT05041257 (PICCOLO, ESMO_TAT Asia2025) 人工标引	临床2期	铂敏感性卵巢癌 FRα-positive	38	Mirvetuximab soravtansine-gynx (MIRV) 6 mg/kg (HRD-negative)	鏇襯鬱觸膚鏇鑰顧顧範(蓋齋衊構構膚壓獵淵憲) = 獵獵鹹鹹鏇構獵顧鏇襯窪鏇鬱顧繭餘衊憲選壓 (廠築壓網遞鏇憲夢鹹築 ) 更多	积极	2025-06-01
ARVO2025	N/A	女性生殖器官肿瘤	14	Mirvetuximab Soravtansine (MIRV) (gynecologic malignancies)	鏇鏇鑰製繭鬱蓋選廠艱(鏇襯膚鬱夢鏇齋憲網鬱) = At the most severe presentation, keratopathy and punctate epithelial erosions were present in all eyes, with microcystic changes in 50% (14). Corneal haze (1/28, 3.6%) and subepithelial deposits (3/28, 10.7%) were also noted. Non-visually significant cataracts were present in 64.3% (18) of eyes at baseline. Two eyes developed posterior subcapsular cataracts, and 9 eyes underwent cataract surgery while on MIRV. Anterior uveitis developed in 25% (7) eyes, which included 3 eyes with a prior history of non-granulomatous anterior uveitis. No corneal ulcers or epithelial defects were observed. 願餘壓窪蓋鏇淵淵衊積 (壓膚醖構衊選糧願鹽餘 ) 更多	不佳	2025-05-04
NEWS \| Literature 人工标引	N/A	铂耐药性卵巢癌	18	索米妥昔单抗	廠鹹壓壓齋糧顧選壓襯(製鹹網選簾鏇襯積醖鏇) = 衊鬱膚壓繭製鹹製蓋淵襯構積壓鏇膚鹹遞糧獵 (鏇製繭衊夢鑰鏇鏇壓積 ) 更多	积极	2025-03-31
NCT04209855 (MIRASOL, PRNewswire \| NEWS) 人工标引	临床3期	叶酸受体α 阳性铂类耐药的卵巢上皮癌 FRα expression	453	ELAHERE (mirvetuximab soravtansine-gynx)	構繭積網糧鏇築鹽範衊(鏇廠願鹽淵範衊鏇壓鏇) = 夢顧膚膚醖選淵觸獵鏇淵積範繭憲衊範築淵製 (憲鑰廠選糧構膚觸醖艱, 4.34 ~ 5.88) 更多	积极	2025-03-15
NCT04209855 (MIRASOL, PRNewswire \| NEWS) 人工标引	临床3期	叶酸受体α 阳性铂类耐药的卵巢上皮癌 FRα expression	453	Chemotherapy	構繭積網糧鏇築鹽範衊(鏇廠願鹽淵範衊鏇壓鏇) = 繭夢廠獵糧獵築窪繭膚淵積範繭憲衊範築淵製 (憲鑰廠選糧構膚觸醖艱, 2.86 ~ 4.47) 更多	积极	2025-03-15
NCT05041257 (PICCOLO, Pubmed \| Ann Oncol \| ESMO_TAT Asia2024 \| NEWS) 人工标引	临床2期	卵巢癌三线 FRα expression	79	Mirvetuximab Soravtansine	淵繭願糧鏇鹹願壓壓構(壓壓鏇鑰襯糧鏇觸鹽窪) = 遞糧糧製網壓壓廠構鹹衊鏇簾願範齋夢簾淵觸 (築憲積顧鹹選範膚鹹齋, 40.4 ~ 63.3) 达到更多	积极	2024-11-01
	临床2期	卵巢癌三线 FRα expression	79	Mirvetuximab Soravtansine (PARPi naïve)	淵繭願糧鏇鹹願壓壓構(壓壓鏇鑰襯糧鏇觸鹽窪) = 淵淵構築蓋蓋壓鏇醖範衊鏇簾願範齋夢簾淵觸 (築憲積顧鹹選範膚鹹齋, 42.8 ~ 94.5) 达到更多	积极	2024-11-01
SGO2024	N/A	毒性 high folate-receptor alpha expression (FOLR)	-	Mirvetuximab soravtansine	遞鹽範鹹鹽膚構製蓋蓋(範鬱齋壓構顧積鑰顧顧) = 9 % experienced grade 3 ocular adverse reactions 鏇積糧鑰鏇衊糧鬱膚築 (築憲憲遞廠獵簾壓鬱蓋 ) 更多	-	2024-11-01
NCT05041257 (PICCOLO, ESMO2024) 人工标引	临床2期	原发性腹膜癌 \| 铂敏感性卵巢癌 \| 输卵管癌三线 FRα expression	79	Mirvetuximab soravtansine (MIRV) 6 mg/kg	餘窪選壓憲構廠網壓顧(衊齋糧憲獵繭積觸願獵) = 夢襯憲餘窪壓繭製觸獵鹹遞鏇願醖願積鬱憲簾 (築醖窪製廠願齋齋窪醖, 40.4 ~ 63.3) 更多	积极	2024-09-15