Clinical Study on the Efficacy and Safety of Disitamab Vedotin Combined With Iparomlimab and Tuvonralimab in the Second-Line Treatment of HER2-Expressing Recurrent Cervical Cancer

This is a single-arm study. The efficacy and safety of Disitamab Vedotin combined with Apalutamide and Toripalimab in the second-line treatment of HER2-expressing recurrent cervical cancer are evaluated based on the following indicators:
Primary evaluation indicator: Objective Response Rate (ORR)
Secondary evaluation indicators:
Efficacy-related indicators: Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), Overall Survival (including median Overall Survival [mOS] and 1-year, 2-year, 3-year Overall Survival rates) Safety-related indicators: Adverse Events (AEs) and Serious Adverse Events (SAEs).

开始日期2025-10-01

申办/合作机构

山东大学齐鲁医院

ChiCTR2500108466

/ Not yet recruiting临床2期IIT

Comparing the combination of Disitamab vedotin (RC48), Xindilimab, and SOX regimen for the perioperative treatment of locally advanced gastric cancer with HER-2 overexpression using SOX regimen: A prospective, multicenter, phase II clinical study.

开始日期2025-09-15

申办/合作机构

Self Finance, Inc.

NCT07194005

/ Recruiting临床2期IIT

Efficacy and Safety of RC48 (Disitamab Vedotin) Combined With Sintilimab and SOX for HER2 IHC 1+/2+ Unresectable Locally Advanced or Advanced Gastric Cancer Conversion Therapy

This study aims to evaluate the efficacy of disitamab vedotin in combination with sintilimab and SOX as conversion therapy in patients with initially unresectable locally advanced or metastatic gastric cancer exhibiting HER2 IHC 1+/2+ expression. The trial plans to enroll patients with a single initial unresectable factor and HER2 IHC 1+/2+ status. Participants will receive disitamab vedotin combined with sintilimab and SOX for 4 to 6 treatment cycles. Those who achieve successful conversion will undergo surgical resection, while patients with unsuccessful conversion will either continue the original regimen or switch to an alternative treatment at the investigator's discretion.

开始日期2025-09-04

申办/合作机构

复旦大学

100 项与维迪西妥单抗相关的临床结果

登录后查看更多信息

100 项与维迪西妥单抗相关的转化医学

登录后查看更多信息

100 项与维迪西妥单抗相关的专利（医药）

登录后查看更多信息

654

项与维迪西妥单抗相关的文献（医药）

2025-12-31·mAbs

A bispecific antibody-drug conjugate targeting pCAD and CDH17 has antitumor activity and improved tumor-specificity

作者: Gesner, Thomas ; Logel, Claude ; Xie, Kathleen T. ; Cebe, Regis ; Wu, Nila C. ; Li, Xun ; Shi, Xingyi ; Velazquez, Roberto ; Simmons, Quincey ; Tschantz, William R. ; Barzaghi-Rinaudo, Patrizia ; Korn, Joshua ; Sagar, Vivek ; Hainzl, Dominik ; Malamas, Anthony ; Mercan, Samuele ; Green, Andrew ; McLaughlin, Margaret ; Huber, Thomas ; Mueller, Kathrin ; Synan, Alyssa ; D’Alessio, Joseph A.

P-cadherin (pCAD) and LI-cadherin (CDH17) are cell-surface proteins belonging to the cadherin superfamily that are both highly expressed in colorectal cancer.This co-expression profile presents a novel and attractive opportunity for a dual targeting approach using an antibody-drug conjugate (ADC).In this study, we used a unique avidity-driven in vitro screening approach to generate pCAD x CDH17 bispecific antibodies that selectively target cells expressing both antigens over cells expressing only pCAD or only CDH17.Based on in vitro binding and inhibition of cell proliferation results, we selected a lead bispecific antibody to link to the cytotoxic payload monomethyl auristatin E (MMAE) to generate a pCAD x CDH17 bispecific MMAE ADC.In in vivo dual flank mouse models, we demonstrated antitumor activity of the bispecific ADC in tumors expressing both antigens but not in tumors expressing only pCAD or only CDH17.Overall, the preclin. data presented here support the proof-of-concept bispecific antibody discovery approach, demonstrating a rational design for screening antibodies by prioritizing cross-arm avid IgGs to target dual-pos. cells.

2025-10-01·NEOPLASIA

Disitamab vedotin combined with toripalimab and radiotherapy for multimodal organ-sparing treatment of muscle invasive bladder cancer: a proof-of-concept study

Article

作者: Zhang, Ruiyun ; Xie, Feng ; Xia, Jun ; Zhuang, Guanglei ; Chen, Haige ; Zhang, Tianxiang ; Cao, Dengfeng ; Zhang, Lu ; Tang, Haoran ; Qian, Lei ; Zang, Jingyu ; Ding, Yu ; Wu, Yuchen ; Jin, Di

PURPOSE:

Although trimodal therapy is currently the standard organ-sparing approach for muscle-invasive bladder cancer (MIBC), its clinical benefit is limited, and noninvasive biomarkers to guide dynamic decision-making are lacking. Here, we present a proof-of-concept study evaluating disitamab vedotin (RC48, a HER2-targeted antibody-drug conjugate) combined with toripalimab (JS001, anti-PD-1) and radiotherapy for bladder preservation in localized HER2-positive MIBC.

PATIENTS AND METHODS:

In the first-stage of an open-label phase II clinical trial (ClinicalTrials.gov identifier: NCT05979740), six patients were enrolled and received disitamab vedotin, toripalimab, and radiotherapy. Adverse events were documented according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5.0). Tumor response was evaluated every 12 weeks by radiographic imaging, cystoscopy with biopsies, and urine cytology. In parallel, we performed longitudinal liquid biopsy analyses of circulating tumor DNA (ctDNA) and urinary tumor DNA (utDNA) using PredicineCARE assay.

RESULTS:

The combination was overall tolerable, with no grade 4 treatment-related adverse events or deaths. Five patients (83.3 %) achieved a complete response and remained recurrence-free. Notably, utDNA testing showed high accuracy in monitoring therapeutic effectiveness and enabled early detection of tumor relapse, whereas ctDNA was largely undetectable across blood samples.

CONCLUSIONS:

These findings establish the feasibility, efficacy, and potential biomarker utility of a novel bladder-preserving regimen, setting the stage for a paradigm shift in MIBC management.

2025-09-02·Future Oncology

SGNDV-001: disitamab vedotin with pembrolizumab in HER2-expressing locally advanced or metastatic urothelial carcinoma

Article

作者: Drakaki, Alexandra ; Zhang, Wei ; Powles, Thomas B. ; Franco, Sonia ; Loriot, Yohann ; Apolinario, Kristel ; Grande, Enrique ; Kanesvaran, Ravindran ; Galsky, Matthew D. ; Oliveira, Niara ; Alimohamed, Nimira ; Jiang, Dingfeng ; Necchi, Andrea ; Sridhar, Srikala S.

INTRODUCTION:

Platinum-based chemotherapy for the treatment of locally advanced or metastatic urothelial carcinoma (la/mUC), has been the first-line standard of care for many decades. Enfortumab vedotin, an antibody-drug conjugate, combined with pembrolizumab, a programmed death 1 (PD-1) inhibitor, recently demonstrated improved efficacy versus chemotherapy in la/mUC. Since 60%-80% of patients with UC have tumors expressing human epidermal growth factor receptor 2 (HER2), HER2-directed vedotin-based antibody-drug conjugates may also be beneficial in la/mUC.

PATIENTS AND METHODS:

The phase 3 trial SGNDV-001 (C5731001; NCT05911295) is evaluating disitamab vedotin (HER2-directed antibody-drug conjugate) with pembrolizumab compared with chemotherapy in treatment-naive patients with HER2-expressing la/mUC. Dual primary endpoints are progression-free survival (per blinded independent central review) and overall survival. Potential synergistic effects of disitamab vedotin and pembrolizumab could establish this combination as a novel therapeutic option for HER2-expressing la/mUC.

874

项与维迪西妥单抗相关的新闻（医药）

2025-09-26

·今日头条

2025 ESMO中国主场时刻：十款新药横扫肺癌、胃癌、肝癌等六大癌种

2025年欧洲肿瘤内科学会（ESMO）年会将于10月17-21日在德国柏林召开。作为欧洲最负盛名、最具影响力的肿瘤学会议，其内容涵盖从基础研究到肿瘤免疫治疗的最新发现，从肿瘤护理到姑息治疗的临床实践，从罕见癌症诊疗到药物批准进展等多个维度。值得一提的是，在大会最新公布的“重磅突破摘要”（Late-Breaking Abstract，LBA）中，中国学者主导的研究表现亮眼：入选数量创历史新高，共23项研究跻身LBA行列，其中3项更入选最高学术等级的“主席论坛（Presidential Symposium）”。这些研究覆盖肺癌、乳腺癌、胃癌、尿路上皮癌等高发瘤种，囊括核药、抗体药物偶联物（ADC）、免疫联合疗法等前沿方向，显著彰显了中国创新药在国际肿瘤学界的突破与影响力。下面，全球肿瘤医生网医学部将为大家梳理本次会议中中国LBA研究的关键信息摘要，以供癌友们参考。我们坚信，每一项研究突破都在拉近“癌症可治”的梦想，每一份坚持都将铸就生命的奇迹！ 2025 ESMO硬核清单！十款国产创新药硬核登场，横扫肺癌、乳腺癌、胃癌、宫颈癌、肝癌等六大癌种 ▲截图源自“ESMO” 肺癌领域：国产双抗头对头Ⅲ期胜出 PART 1 （一）摘要号：LBA4（依沃西单抗）讲者：陆舜 | 上海交通大学医学院附属胸科医院。意义：首个国产双抗在Ⅲ期研究中头对头战胜PD-1单抗，有望重新定义晚期肺鳞癌一线标准。研究名称（英文/中文） Title: Phase III Study of Ivonescimab plus chemotherapy versus Tislelizumab plus chemotherapy as First-line Treatment for advanced squamous non-small cell lung cancer（HARMONi-6，AK112-306）（HARMONi-6：探索依沃西单抗联合化疗对比替雷利珠单抗联合化疗作为晚期鳞状非小细胞肺癌一线治疗的III期研究）。药物简介依沃西单抗（Ivonescimab，AK112）是我国自主研发的一款全球首创PD-1/VEGF双特异性抗体新药，凭借“肿瘤免疫+抗血管生成”双靶点协同的创新机制，既能有效阻断PD-1与PD-L1/L2的结合，又能精准抑制VEGF与受体的相互作用，为肺癌治疗开辟了全新选择。 ESMO前沿数据抢先看 HARMONi-6研究是ivonescimab（依沃西单抗）在肺癌领域取得积极成果的第三次Ⅲ期临床试验，核心价值在于为突破贝伐珠单抗治疗鳞状非小细胞肺癌（sqNSCLC）的局限性提供了关键证据。该试验共纳入532名患者，其中约63%为中心型鳞状细胞癌。中期分析结果显示：在意向治疗（ITT）人群中，ivonescimab联合化疗的无进展生存期（PFS）显著优于替雷利珠单抗（tislelizumab）联合化疗；且这一获益具有广谱性，在PD-L1阳性与PD-L1阴性人群中均体现出临床意义。安全性方面，ivonescimab未出现新的安全信号，即便在占比高达63%的中心型鳞癌患者中仍保持良好表现，进一步凸显其突破贝伐珠单抗治疗局限的潜力，有望增强免疫疗法在非小细胞肺癌中的临床获益。此前，另一项III期HARMONi-2试验（NCT05499390）的结果已在国际顶级医学期刊《柳叶刀》发表，针对先前未接受治疗的局部晚期或转移性PD-L1阳性非小细胞肺癌（NSCLC）患者，进一步印证了ivonescimab的显著疗效。结果显示：ivonescimab组中位PFS达11.1个月，远超帕博利珠单抗（pembrolizumab）组的5.8个月，使患者中位PFS显著延长近5.3个月，以压倒性优势刷新该类患者的治疗标准。 ▲图源“Lancet”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除（二）摘要号：LBA66（恩沙替尼）讲者：岳东升 | 天津医科大学肿瘤医院。意义：ALK抑制剂的突破，若无病生存期（DFS）显著延长，该药或成为术后辅助治疗的新选择。研究名称（英文/中文） Ensartinib as adjuvant therapy in patients (pts) with stage IB–IIIB ALK-positive (ALK+) non-small cell lung cancer (NSCLC) after complete tumor resection: the phase III randomized ELEVATE trial（恩沙替尼作为IB–IIIB期ALK阳性非小细胞肺癌患者肿瘤完全切除后的辅助治疗：III期随机ELEVATE试验）。药物简介恩沙替尼（Ensartinib，X-396，贝美纳®）是贝达药业控股子公司Xcovery研发的一款ALK抑制剂，同时也是首个进入 ALK 阳性 NSCLC 术后辅助治疗 III 期临床的中国原研药物。2024年12月18日获美国FDA批准，用于成人先前未接受过ALK抑制剂治疗的间变性淋巴瘤激酶（ALK）阳性局部晚期或转移性非小细胞肺癌的治疗。 ESMO前沿数据抢先看《肿瘤前沿》曾报道过一个应用恩沙替尼治疗EML4-ALK融合阳性IIIA期非小细胞肺癌（NSCLC）的振奋案例。该患者是一位60岁女性，确诊左下肺腺癌，分期为IIIA期（cT2aN2aM0，TNM第9版），且存在EML4-ALK融合基因。经恩沙替尼新辅助治疗3个月后，患者达到部分缓解（PR），胸部CT显示肿瘤体积缩小50%，纵隔淋巴结亦部分缩小（详见下图）。此次欧洲肿瘤内科学会（ESMO）大会将公布恩沙替尼作为首个聚焦中国原研ALK抑制剂，用于术后辅助治疗的III期注册研究数据，有望填补更广泛早期ALK阳性NSCLC人群的治疗空白！ ▼新辅助治疗前后左肺腺癌胸部CT图像 ▼新辅助治疗前后胸部淋巴结CT图像 ▲图源“Front Oncol”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除（三）摘要号：LBA5（芦康沙妥珠单抗-肺癌）讲者：张力 | 中山大学肿瘤防治中心。意义：若数据阳性，芦康沙妥珠单抗可能成为TROP2阳性实体瘤的重要治疗选择。研究名称（英文/中文） Sacituzumab tirumotecan (sac-TMT) vs platinum-based chemotherapy in EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) following progression on EGFR-TKIs: results from the randomized, multi-center phase 3 OptiTROP-Lung04 study（芦康沙妥珠单抗对比铂类化疗应用于EGFR-TKI经治进展的EGFR突变非小细胞肺癌：随机、多中心III期OptiTROP-Lung04研究结果）。药物简介芦康沙妥珠单抗（SKB264，代号：Sac-TMT，商品名：佳泰莱®）是中国科伦博泰生物依托其享誉国际的OptiDCADC研发平台开发的代表性创新药物，为靶向TROP2的抗体药物偶联物（ADC）。TROP2是一种广泛表达于多种上皮肿瘤表面的跨膜糖蛋白，在非小细胞肺癌（NSCLC）治疗领域被视为极具潜力的靶点。 2025年3月10日，该药获国家药品监督管理局（NMPA）批准上市，用于治疗经表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）和含铂化疗治疗失败的局部晚期或转移性EGFR突变非小细胞肺癌（NSCLC）成人患者。至此它也成为了首款中国原创的用于肺癌治疗的TROP2新型抗体偶联药物（ADC）。 ESMO前沿数据抢先看 2025年美国临床肿瘤学会（ASCO）大会曾公布代号为OptiTROP-Lung03的关键临床研究结果。该研究共纳入43例经多线治疗的局部晚期或转移性非小细胞肺癌（NSCLC）患者，其中22例为EGFR-TKI耐药患者，且45.5%接受过第三代EGFR-TKI治疗。数据显示，研究总体客观缓解率（ORR）为43.6%；而在EGFR突变亚组中，患者接受芦康沙妥珠单抗单药治疗的ORR高达60%，同时伴随显著的生存获益——中位缓解持续时间（DoR）达8.7个月，中位无进展生存期（PFS）长达11.5个月，中位总生存期（OS）达22.7个月，12个月和18个月OS率分别高达81.0%和76.2%。这表明，芦康沙妥珠单抗单药治疗对EGFR突变患者的获益更为显著。此次欧洲肿瘤内科学会（ESMO）大会将进一步更新OptiTROP-Lung04研究的最新数据，让我们拭目以待！乳腺癌领域：TROP2-ADC中国Ⅲ期登顶 PART 2 （四）摘要号：LBA23（芦康沙妥珠单抗-乳腺癌）讲者：樊英 | 中国医学科学院肿瘤医院。意义：国产TROP2-ADC首次在欧洲主舞台发布阳性Ⅲ期结果，填补中国ADC药物在国际乳癌一线空白。研究名称（英文/中文） Sacituzumab tirumotecan (sac-TMT) vs investigator's choice of chemotherapy (ICC) in previously treated locally advanced or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer (BC): results from the randomized, multi-center phase 3 OptiTROP-Breast02 study[芦康沙妥珠单抗（sac-TMT）对比研究者选择的化疗（ICC）治疗既往经治局部晚期或转移性HR阳性/HER2阴性（HR+/HER2-）乳腺癌（BC）：随机、多中心III期OptiTROP-Breast02研究结果]。药物简介芦康沙妥珠单抗除了治疗肺癌外，还可用于乳腺癌的治疗。2025年5月16日，该药被中国国家药监局药品审评中心（CDE）纳入优先评审，用于成人既往接受过内分泌治疗，且在晚期或转移性阶段接受过其他系统治疗的不可切除局部晚期或转移性激素受体阳性（HR+）、人表皮生长因子受体2阴性（HER2-）乳腺癌的治疗。好消息是，目前该药已启动临床招募。阅读原文了解详情：【ADC药物】新一代靶向药SKB264（芦康沙妥珠单抗）终于启动临床！现正急招乳腺癌患者！ ESMO前沿数据抢先看早在2023年ESMO大会上，曾公布过芦康沙妥珠单抗治疗HR+/HER2阴性转移性乳腺癌（mBC）的I/II期临床数据（NCT04152499）。结果显示：客观缓解率（ORR）为36.8%，疾病控制率（DCR）高达89.5%；中位缓解持续时间（DoR）为7.4个月（4.2-14.9+个月），6个月DoR率80%；中位无进展生存期（PFS）为11.1个月（95%CI：5.4，13.1），6个月PFS率高达61.2%。（五）摘要号：LBA25（库莫西利）讲者：宋尔卫 | 中山大学孙逸仙纪念医院。意义：若数据优于现有CDK4/6抑制剂，可能为内分泌治疗提供新策略。研究名称（英文/中文） Culmerciclib Plus Fulvestrant as First-Line Treatment for HR+/HER2- Advanced Breast Cancer: A Phase 3 Trial (CULMINATE-2)[Culmerciclib（库莫西利）联合氟维司群一线治疗 HR+/HER2-晚期乳腺癌：一项III期试验 (CULMINATE-2)]。药物简介库莫西利胶囊（Culmerciclib，TQB3616）是正大天晴研发的一款新型CDK2/4/6抑制剂，对CDK2、CDK4、CDK6激酶均有抑制作用，尤其对CDK4激酶抑制能力较强，有望解决当前CDK4/6抑制剂的耐药难题。 2025年7月9日，该药的第2项适应症上市申请获受理，新增适应症为联合氟维司群注射液，用于HR+/HER2-局部晚期或转移性乳腺癌患者的初始内分泌治疗。 ESMO前沿数据抢先看据悉，库莫西利联合氟维司群一线治疗HR+/HER2-乳腺癌的III期临床研究（TQB3616-III-02），已完成独立数据监测委员会（IDMC）规定的方案中期分析，判定有效性达到预设的优效性阈值。联合治疗总体安全且耐受性良好。胃癌领域：PD-1/CTLA-4双抗再下一城 PART 3 （六）摘要号：LBA78（安尼妥单抗）讲者：徐建明 | 中国人民解放军总医院。研究名称（英文/中文） KN026 in combination with chemotherapy for previously treated HER2 positive gastric or gastroesophageal carcinomas (GC/GEJC): Interim analysis of KC-WISE [KN026联合化疗治疗既往接受过治疗的HER2阳性胃癌或胃食管交界癌（GC/GEJC）：KC-WISE研究的中期分析]。药物简介安尼妥单抗（KN026）是康宁杰瑞自主研发的新型HER2靶向双特异性抗体，核心优势在于可同时结合HER2的两个非重叠表位，实现对HER2信号的强效阻断。2025年9月11日，其新药上市申请获中国国家药品监督管理局正式受理，适应症为与化疗联合，用于至少接受过一种含曲妥珠单抗联合化疗的系统性治疗失败后、HER2阳性的局部晚期、复发或转移性胃/胃食管结合部腺癌。它也成为了首个提交上市申请的国产HER2双抗，填补了国产HER2双抗在胃癌治疗赛道的上市申请空白。好消息是，目前该药正在针对乳腺癌等实体瘤开展临床招募。阅读原文了解详情：【HER2药物】新一代靶向药KN026联合HB1801终于启动临床，现急招乳腺癌患者！ ESMO前沿数据抢先看 2024年，国际期刊《肿瘤学年鉴》公布了安尼妥单抗（KN026）联合化疗治疗无法切除或转移性HER2阳性胃癌/胃食管结合部癌（GC/GEJC）临床研究（NCT05427383）的振奋数据。结果显示：经独立评审委员会（IRC）确认，客观缓解率（ORR）为40.0%（95%CI：23.9-57.9）；疾病控制率（DCR）达80.0%（95%CI：63.1-91.6），其中14例达部分缓解（PR）、8例达病情稳定（SD）。中位无进展生存期（PFS）为8.6个月（95%CI：3.78-13.11），中位总生存期（OS）为13.2个月（95%CI：10.58-20.53）。（七）摘要号：LBA83（RC118）讲者：余一祎 | 复旦大学附属中山医院。意义：CLDN18.2 作为胃癌治疗领域的新兴靶点，其与免疫治疗的联合策略有望有效克服临床耐药难题。研究名称（英文/中文） RC118 (CLDN18.2-targeted ADC) combined with PD-1 blockade or RC148 (PD-1/VEGF bispecific antibody) for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (la/m G/GEJA)[RC118（CLDN18.2靶向ADC）联合PD-1抑制剂或RC148（PD-1/VEGF双特异性抗体）治疗局部晚期/转移性胃癌/胃食管交界腺癌（la/m G/GEJA）]。药物简介 RC118是一款靶向Claudin18.2的ADC药物，已用于治疗局部晚期不可切除或转移性恶性实体瘤。 ESMO前沿数据抢先看此次ESMO大会将公布RC118联合PD-1抑制剂/双抗，用于局部晚期或转移性胃癌/胃食管交界腺癌，探索CLDN18.2高表达人群的疗效。尿路上皮癌领域：国产HER2-ADC冲击一线 PART 4 （八）摘要号：LBA7（维迪西妥单抗）讲者：盛锡楠 | 北京大学肿瘤医院。意义：HER2低表达（IHC1+）患者首次在UC治疗中显示临床获益，可能扩大HER2靶向治疗的适用人群。若阳性，将成为全球首个HER2-ADC联合免疫一线治疗尿路上皮癌的Ⅲ期证据。研究名称（英文/中文） Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression（维迪西妥单抗联合特瑞普利单抗对比化疗应用于HER2表达局部晚期或转移性尿路上皮癌一线治疗）。药物简介维迪西妥单抗（Disitamab Vedotin，爱地希®）是由荣昌制药研发的一款靶向HER2的ADC药物，同时也是我国首个治疗尿路上皮癌且靶向HER2的ADC药物。由新型人源化抗HER2抗体、微管抑制剂MMAE、可裂解连接子组成。2021年6月9日，获中国国家药监局（NMPA）批准，作为二线治疗用于既往接受过含Pt化疗的局部晚期或转移性HER2阳性尿路上皮癌、至少两种全身化疗方案的HER2阳性局部晚期或转移性胃癌的治疗。 ESMO前沿数据抢先看《临床肿瘤学杂志》曾报告过维迪西妥单抗Ⅱ期临床研究的振奋数据。该研究共入组107例HER2阳性、且至少接受过一线全身化疗后病情出现进展的局部晚期或转移性尿路上皮（UC）患者。结果显示：总体缓解率（ORR）高达50.5%（95%CI，40.6~60.3）。中位总生存期（OS）长达14.2个月（95%CI，9.7~18.8），中位无进展生存期（PFS）为5.9个月（95%CI，4.3~7.2），中位缓解持续时间为7.3个月（95%CI，5.7~10.8）。宫颈癌领域 PART 5 （九）摘要号：LBA38（卡瑞利珠单抗）讲者：吴小华 | 复旦大学附属肿瘤医院。研究名称（英文/中文） Phase 3 study of camrelizumab plus famitinib versus platinum-based chemotherapy as first-line therapy for recurrent or metastatic cervical cancer（卡瑞利珠单抗联合法米替尼对比铂类化疗一线治疗复发性或转移性宫颈癌的III期研究）。药物简介卡瑞利珠单抗（camrelizumab，艾瑞卡®）是恒瑞医药自主研发的一款人源化 PD-1 单克隆抗体2025年5月21日，该药第十个适应症获中国药监局批准，与“苹果酸法米替尼”联合，用于既往接受含铂化疗失败的复发或转移性宫颈癌的治疗！ ESMO前沿数据抢先看全球知名期刊《柳叶刀》曾发表过卡瑞利珠单抗治疗局部晚期宫颈癌Ⅱ期NACI研究（NCT04516616）的振奋数据。结果显示：客观缓解率（ORR）高达98%（95%CI：92-100），其中19%（16例）达到完全缓解（CR），79%（67例）实现部分缓解（PR）。肝癌领域 PART 6 （十）摘要号：LBA52（诺法利单抗）讲者：任正刚 | 复旦大学附属中山医院。研究名称（英文/中文） Nofazinlimab combined with lenvatinib versus placebo plus lenvatinib as first-line therapy for unresectable or metastatic hepatocellular carcinoma: a phase 3, randomized, double-blind, multiregional study (CS1003-305) [Nofazinlimab联合仑伐替尼对比安慰剂联合仑伐替尼对比作为不可切除或转移性肝细胞癌一线治疗：一项III期、随机、双盲、多中心研究（CS1003-305）]。药物简介诺法利单抗（Nofazinlimab）是基石药业研发的一款靶向人类程序性细胞死亡蛋白1（PD-1）的人源化重组IgG4单克隆抗体，其核心作用机制为阻断PD-1与其配体PD-L1、PD-L2的相互作用。 2020年7月，该药获美国食品药品监督管理局（FDA）授予孤儿药资格（ODD），适应症为治疗肝细胞癌（HCC）患者。目前，nofazinlimab正针对实体瘤领域开发相关治疗方案。 ESMO前沿数据抢先看 CS1003-305是一项全球多中心、双盲、随机3期注册临床试验，核心目的是评估诺法齐利单抗（Nofazinlimab）联合仑伐替尼，对比安慰剂联合仑伐替尼治疗不可切除晚期肝细胞癌患者的疗效与安全性。2022年3月，该研究已顺利达成预定的患者入组目标。此前，在2022年美国临床肿瘤学会（ASCO）年会上，曾披露过CS1003-102研究的1b期数据。针对中国不可切除肝细胞癌患者的分析显示，诺法齐利单抗联合仑伐替尼作为一线治疗具有良好疗效与可控安全性：客观缓解率（ORR）达45.0%；截至数据截止日期，中位缓解持续时间（DoR）尚未达到（范围：4.2至18.7+个月），中位无进展生存期（PFS）为10.4个月。小编寄语过去十年，癌症治疗领域取得了长足进步，显著延长了晚期癌症患者的生存期。在2025年ESMO大会上，中国研究更是呈现出三大鲜明特点：一是核药与ADC（抗体药物偶联物）成为新的研发焦点；二是免疫联合治疗向新辅助、辅助治疗阶段延伸；三是生物标志物驱动的精准治疗实现快速发展。这些研究不仅充分展现了中国创新药的研发实力，更有望推动全球肿瘤治疗指南的更新迭代。随着中国药企在国际多中心试验（MRCT）中参与度的持续提升，未来或将有更多中国原研药物改写全球癌症临床实践。参考资料 [1]Xiong A,et al.Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China[J]. The Lancet, 2025, 405(10481): 839-849. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02722-3/abstract [2]Zhang H,et al.Ensartinib as a neoadjuvant therapy for stage IIIA non-small cell lung cancer patients with EML4-ALK fusion: a case report and literature review. Front Oncol. 2025 Feb 25;15:1474997. https://pmc.ncbi.nlm.nih.gov/articles/PMC11893432/ 本文为全球肿瘤医生网原创，未经授权严禁转载

临床3期抗体药物偶联物免疫疗法引进/卖出临床成功

2025-09-24

·FiercePharma

In potential $1.1B deal, Glenmark grabs certain rights to Hengrui's ADC rival to Enhertu

Jiangsu Hengrui Pharmaceuticals is licensing certain rights to its HER2 antibody-drug conjugate trastuzumab rezetecan to Glenmark. Jiangsu Hengrui Pharmaceuticals’ dealmaking spree rolls on, with a potential $1.1 billion transaction on a rival to AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu being the latest addition.Hengrui is licensing certain rights to its HER2 antibody-drug conjugate trastuzumab rezetecan to a subsidiary of India’s Glenmark Pharmaceuticals, the two parties announced (PDF) Wednesday.The deal is heavily back-loaded, as it features an upfront payment of $18 million and up to $1.09 billion in regulatory and commercial milestones, plus sales-based royalties.The focus is on emerging markets; the partnership excludes the U.S., Canada, Europe, Japan, greater China, Central Asia and a few other countries.“This collaboration with Glenmark is a significant step in Hengrui’s ongoing strategy to deepen its presence in emerging markets,” Jo Feng, president of Hengrui Pharma, said in a Sept. 24 statement (PDF). “We look forward to working together to enhance the accessibility of innovative therapies and to bring new hope to patients in more countries and regions.”For Glenmark, the deal dovetails with the company’s strategy to expand its oncology pipeline, Glenn Saldanha, chairman and managing director of Glenmark Pharmaceuticals, said in a statement. Last year, the Indian pharma bagged rights in certain territories to envafolimab, a subcutaneous PD-L1 inhibitor developed by a trio of Chinese companies. However, that drug has since failed in a pivotal trial in undifferentiated pleomorphic sarcoma or myxofibrosarcoma, forcing its U.S. partner Tracon Pharmaceuticals to close up shop.Hengrui is angling trastuzumab rezetecan as a direct competitor to Enhertu, which generated $3.75 billion in global sales last year and $2.29 billion in the first half of 2025. Both ADCs use trastuzumab as the antibody guide and both utilize an exatecan derivative as the toxic payload. The Hengrui med carries rezetecan, whereas Enhertu leverages deruxtecan.Rezetecan “has high membrane permeability, enabling a bystander killing effect, which further enhances the antitumor efficacy,” Hengrui explained in a securities filing.Trastuzumab rezetecan was approved in China in May 2025 for the treatment of second-line non-small cell lung cancer with HER2-activating mutations, with a breast cancer application also under review by Chinese authorities. The Glenmark licensing deal follows the granting of an orphan drug designation from the FDA for the drug in combination with Hengrui’s PD-L1 inhibitor adebrelimab and chemo in stomach cancer.Besides Enhertu, Hengrui’s HER2 ADC faces another competitor in RemeGen’s China-approved disitamab vedotin, which has been out-licensed to Pfizer. Hengrui has been busy with business development lately. Its recent deals include a potential $12 billion biobucks, up-to-12-asset deal with GSK and a lipoprotein(a) cardiovascular partnership with Merck & Co. that could be worth nearly $2 billion.In addition to HER2, Hengrui’s ADC pipeline covers other popular targets such as TROP2 (targeted by Gilead Sciences’ Trodelvy and AZ and Daiichi’s Datroway), Nectin-4 (targeted by Pfizer and Astellas’ Padcev), Claudin 18.2 (Astellas’ Vyloy), HER3 (Merck and Daiichi’s patritumab deruxtecan) and CD79b (Roche’s Polivy).

引进/卖出上市批准孤儿药抗体药物偶联物

2025-09-23

·ioncology

ESMO 2025丨LBA重磅发布，中国学者23项研究入选！

点击蓝字，关注我们编者按：2025年欧洲肿瘤内科学会（ESMO）年会将于当地时10月17~21日在德国柏林举办，汇聚全球肿瘤学领域前沿理论与进展。此前，ESMO已公布大会常规选题题目，北京时间2025年9月22日，ESMO官网正式“突破性摘要”（Late-Breaking Abstract，LBA），中国学者共有23项研究重磅入选，将在国际舞台展现中国力量！ Presidential Symposium 主席研讨会肺癌摘要号：LBA4 讲题：Phase III Study of Ivonescimab plus chemotherapy versus Tislelizumab plus chemotherapy as First-line Treatment for advanced squamous non-small cell lung cancer (HARMONi-6) HARMONi-6研究：依沃西单抗联合化疗对比替雷利珠单抗联合化疗一线治疗晚期鳞状非小细胞肺癌的III期研究讲者：陆舜上海交通大学医学院附属胸科医院专场：Presidential Symposium 2 时间：2025.10.19 16:30-16:42 地点：Berlin Auditorium - Hub 27 摘要号：LBA5 讲题：Sacituzumab tirumotecan (sac-TMT) vs platinum-based chemotherapy in EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) following progression on EGFR-TKIs: results from the randomized, multi-center phase 3 OptiTROP-Lung04 study 芦康沙妥珠单抗对比含铂类化疗方案治疗EGFR-TKI经治进展的EGFR突变非小细胞肺癌：随机、多中心III期OptiTROP-Lung04研究结果讲者：张力中山大学肿瘤防治中心专场：Presidential Symposium 2 时间：2025.10.19 16:52-17:04 地点：Berlin Auditorium - Hub 27 泌尿系统肿瘤摘要号：LBA7 讲题：Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression 维迪西妥单抗联合特瑞普利单抗对比化疗一线治疗HER2表达局部晚期或转移性尿路上皮癌讲者：盛锡楠北京大学肿瘤医院专场：Presidential Symposium 2 时间：2025.10.19 17:34-17:46 地点：Berlin Auditorium - Hub 27 Proffered paper session & Mini oral Session 优选论文讲题&迷你口头报告乳腺癌摘要号：LBA19 讲题：SHR-A1811 versus pyrotinib plus capecitabine in human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic breast cancer (BC): a multicenter, open-label, randomized, phase 3 study (HORIZON-Breast01) HORIZON-Breast01研究：瑞康曲妥珠单抗对比吡咯替尼联合卡培他滨治疗HER2阳性晚期/转移性乳腺癌：一项多中心、开放标签、随机、III期研究讲者：宋尔卫中山大学孙逸仙纪念医院专场：Proffered paper session 2: Breast cancer, metastatic 时间：2025.10.19 08:40-08:50 地点：Munich Auditorium - CityCube B 摘要号：LBA23 讲题：Sacituzumab tirumotecan (sac-TMT) vs investigator's choice of chemotherapy (ICC) in previously treated locally advanced or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer (BC): results from the randomized, multi-center phase 3 OptiTROP-Breast02 study 芦康沙妥珠单抗对比研究者选择的化疗方案用于既往经治局部晚期或转移性HR+/HER2-乳腺癌：随机、多中心III期OptiTROP-Breast02研究结果讲者：樊英中国医学科学院肿瘤医院专场：Proffered paper session 1: Breast cancer, metastatic 时间：2025.10.18 10:55-11:05 地点：Berlin Auditorium - Hub 27 摘要号：LBA24 讲题：Trastuzumab botidotin vs trastuzumab emtansine (T-DM1) in HER2-positive unresectable or metastatic breast cancer: results from a randomized phase 3 study 博度曲妥珠单抗对比恩美曲妥珠单抗治疗HER2阳性不可切除或转移性乳腺癌：一项随机III期研究结果讲者：胡夕春复旦大学附属肿瘤医院专场：Proffered paper session 1: Breast cancer, metastatic 时间：2025.10.18 11:05-11:15 地点：Berlin Auditorium - Hub 27 摘要号：LBA25 讲题：Culmerciclib Plus Fulvestrant as First-Line Treatment for HR+/HER2- Advanced Breast Cancer: A Phase 3 Trial (CULMINATE-2) CULMINATE-2研究：库莫西利联合氟维司群一线治疗HR+/HER2-晚期乳腺癌：一项III期试验讲者：宋尔卫中山大学孙逸仙纪念医院专场：Mini oral session: Breast cancer, metastatic 时间：2025.10.20 11:15-11:20 地点：Munich Auditorium - CityCube B 上消化道肿瘤摘要号：LBA11 讲题：Neoadjuvant Toripalimab Plus Lenvatinib and GEMOX in Resectable, High-Risk Intrahepatic Cholangiocarcinoma: A Randomized, Multicenter, Open-Label Phase II-III Clinical Trial 特瑞普利单抗联合仑伐替尼及GEMOX方案新辅助治疗可切除高危肝内胆管癌：一项随机、多中心、开放标签II-III期临床试验讲者：施国明复旦大学附属中山医院专场：Mini oral session 2: GI tumours, upper digestive 时间：2025.10.20 08:53-08:58 地点：Berlin Auditorium - Hub 27 摘要号：LBA52 讲题：Nofazinlimab combined with lenvatinib versus placebo plus lenvatinib as first-line therapy for unresectable or metastatic hepatocellular carcinoma: a phase 3, randomized, double-blind, multiregional study (CS1003-305) CS1003-305研究：诺法利单抗联合仑伐替尼对比安慰剂联合仑伐替尼一线治疗不可切除或转移性肝细胞癌：一项III期、随机、双盲、多中心研究讲者：任正刚复旦大学附属中山医院专场：Mini oral session 1: GI tumours, upper digestive 时间：2025.10.18 11:10-11:15 地点：Hanover Auditorium - Hall 7.2c 摘要号：LBA78 讲题：KN026 in combination with chemotherapy for previously treated HER2 positive gastric or gastroesophageal carcinomas (GC/GEJC): Interim analysis of KC-WISE KC-WISE研究中期：KN026联合化疗治疗既往经治的HER2阳性胃癌或胃食管交界癌讲者：徐建明中国人民解放军总医院专场：Proffered Paper session 1: GI tumours, upper digestive 时间：2025.10.17 15:00-15:10 地点：Hamburg Auditorium - CityCube A 摘要号：LBA82 讲题：Tislelizumab combined with induction chemotherapy and concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma: a multicenter, randomized, phase II trial (EC-CRT-002) EC-CRT-002研究：替雷利珠单抗联合诱导化疗及同步放化疗用于局部晚期食管鳞状细胞癌：一项多中心、随机II期试验讲者：习勉中山大学肿瘤防治中心专场：Mini oral session 1: GI tumours, upper digestive 时间：2025.10.18 10:20-10:25 地点：Hanover Auditorium - Hall 7.2c 摘要号：LBA83 讲题：RC118 (CLDN18.2-targeted ADC) combined with PD-1 blockade or RC148 (PD-1/VEGF bispecific antibody) for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (la/m G/GEJA) RC118（CLDN18.2靶向ADC）联合PD-1抑制剂或RC148（PD-1/VEGF双特异性抗体）治疗局部晚期或转移性胃癌/胃食管交界腺癌（la/m G/GEJA）讲者：余一祎复旦大学附属中山医院专场：Mini oral session 1: GI tumours, upper digestive 时间：2025.10.18 10:50-10:55 地点：Hanover Auditorium - Hall 7.2c 摘要号：LBA84 讲题：Efficacy and safety of GFH375 monotherapy in previously treated advanced KRAS G12D-mutant pancreatic ductal adenocarcinoma (PDAC) GFH375单药治疗既往经治的KRAS G12D突变晚期胰腺导管腺癌的疗效与安全性讲者：周爱萍中国医学科学院肿瘤医院专场：Proffered Paper session 2: GI tumours, upper digestive 时间：2025.10.19 10:15-10:25 地点：Berlin Auditorium - Hub 27 肺癌摘要号：LBA66 讲题：Ensartinib as adjuvant therapy in patients (pts) with stage IB–IIIB ALK-positive (ALK+) non-small cell lung cancer (NSCLC) after complete tumor resection: the phase III randomized ELEVATE trial 恩沙替尼于术后辅助治疗IB–IIIB期ALK阳性非小细胞肺癌患者：III期随机ELEVATE研究讲者：岳东升天津医科大学肿瘤医院专场：Mini Oral session 1: Non-metastatic NSCLC 时间：2025.10.20 14:45-14:50 地点：Hamburg Auditorium - CityCube A 摘要号：LBA71 讲题：Final Analysis of First-Line Serplulimab Plus Chemotherapy With or Without HLX04 in Advanced Nonsquamous Non-small Cell Lung Cancer: the ASTRUM-002 Phase 3 Study III期ASTRUM-002研究最终分析：斯鲁利单抗和化疗联合或不联合HLX04一线治疗晚期非鳞状非小细胞肺癌讲者：石远凯中国医学科学院肿瘤医院专场：Mini oral session 2 : NSCLC metastatic 时间：2025.10.20 10:15-10:20 地点：Berlin Auditorium - Hub 27 摘要号：LBA73 讲题：Final overall survival (OS) and safety analysis of the Phase 3 ALEX study of alectinib vs crizotinib in patients with previously untreated, advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC) III期ALEX研究最终总生存期和安全性分析结果：阿来替尼对比克唑替尼用于初治晚期ALK阳性非小细胞肺癌讲者：莫树锦香港中文大学专场：Proffered paper session: NSCLC metastatic 时间：2025.10.17 17:10-17:20 地点：Berlin Auditorium - Hub 27 头颈肿瘤（新药研发专场&支持治疗专场）摘要号：LBA35 讲题：Iza-Bren (BL-B01D1), an EGFR×HER3 Bispecific Antibody-drug Conjugate, versus Physician's Choice of Chemotherapy in Heavily Pretreated Recurrent/Metastatic Nasopharyngeal Carcinoma: A Randomized, Open-Label, Multicenter, Phase III, Pivotal study (BL-B01D1-303) EGFR×HER3双特异性抗体-药物偶联物 Iza-Bren（BL-B01D1）对比医生选择的化疗方案治疗重度经治后复发/转移性鼻咽癌：一项随机、开放标签、多中心、III期、关键研究（BL-B01D1-303）讲者：周华强中山大学肿瘤防治中心专场：Proffered paper session: Developmental therapeutics 时间：2025.10.19 15:55-16:05 地点：Bremen Auditorium - Hall 6.2 摘要号：LBA103 讲题：Early Versus Routine Oral Nutritional Supplements During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma: Efficacy and Cost-Utility Analysis in a Multicenter Randomized Controlled Trial 鼻咽癌同步放化疗期间早期干预对比常规口服营养补充剂的疗效及成本效用分析：一项多中心随机对照试验讲者：苏丽福建医科大学附属第一医院专场：Mini oral session: Supportive and palliative care 时间：2025.10.18 15:25-15:30 地点：Karlsruhe Auditorium - Hall 5.2 肉瘤摘要号：LBA97 讲题：Legubicin versus doxorubicin (DOX) in patients (pts) with advanced soft tissue sarcoma (STS): results of randomized, phase II/III study 莱古比星对比多柔比星治疗晚期软组织肉瘤（STS）的随机、II/III期研究结果讲者：沈赞上海市第六人民医院专场：Proffered paper session: Sarcoma 时间：2025.10.19 16:30-16:40 地点：Dortmund Auditorium - Hall 7.1a 摘要号：LBA99 讲题：BIOmarker driven trial of Vegf2 inhibitor in Advanced or metastatic Sarcoma (the BIOVAS trial): results of the SNP positive cohort and the CSF1 high cohort 生物标志物驱动的VEGF2抑制剂治疗晚期或转移性肉瘤中试验（BIOVAS 试验）：SNP阳性队列和CSF1高表达队列的结果讲者：鲍其远上海交通大学医学院附属瑞金医院专场：Mini oral session: Sarcoma 时间：2025.10.17 16:00-16:05 地点：Essen Auditorium - Hall 7.2a 妇科肿瘤摘要号：LBA38 讲题：Phase 3 study of camrelizumab plus famitinib versus platinum-based chemotherapy as first-line therapy for recurrent or metastatic cervical cancer 卡瑞利珠单抗联合法米替尼对比含铂化疗一线治疗复发性或转移性宫颈癌的III期研究讲者：吴小华复旦大学附属肿瘤医院专场：Proffered paper session: Gynaecological cancers 时间：2025.10.19 14:45-14:55 地点：Hamburg Auditorium - CityCube A 神经内分泌肿瘤摘要号：LBA63 讲题：XT-XTR008-3-01: a phase III study of 177Lu-Dotatate versus high-dose octreotide long-acting repeatable (LAR) in patients with advanced grade 1–2, well-differentiated, gastroenteropancreatic neuroendocrine tumours (GEP-NETs) XT-XTR008-3-01：一项对比177Lu-Dotatate对比高剂量长效奥曲肽治疗高级别1-2级、高分化胃肠道胰腺神经内分泌肿瘤（GEP-NETs）患者疗效的III期临床研究讲者：刘容锐中国人民解放军总医院专场：Proffered Paper session: NETs and endocrine tumours 时间：2025.10.18 11:15-11:25 地点：Karlsruhe Auditorium - Hall 5.2 中枢神经肿瘤摘要号：LBA27 讲题：SM-1 (procaspase-3 agonist) combined with temozolomide for recurrent high-grade glioma: first-in-class trial SM-1（CASP3前体激动剂）联合替莫唑胺治疗复发性高级别胶质瘤：首创新药试验讲者：康庄首都医科大学附属北京天坛医院专场：Mini Oral session: CNS tumours 时间：2025.10.19 09:00-09:05 地点：Karlsruhe Auditorium - Hall 5.2 （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床3期

100 项与维迪西妥单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01X	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
乳腺癌肝脏转移	中国	荣昌生物制药（烟台）股份有限公司	2025-04-30
HER2阳性尿路上皮癌	中国	荣昌生物制药（烟台）股份有限公司	2021-12-31
HER2阳性胃癌	中国	荣昌生物制药（烟台）股份有限公司	2021-06-08

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
HER2低表达乳腺癌	申请上市	中国	荣昌生物制药（烟台）股份有限公司	2025-06-04
HER2低表达胃食管交界处癌	临床3期	中国	荣昌生物制药（烟台）股份有限公司	2025-05-15
胃食管交界处腺癌	临床3期	中国	荣昌生物制药（烟台）股份有限公司	2025-04-25
HER2阳性胃食管结合部腺癌	临床3期	中国	荣昌生物制药（烟台）股份有限公司	2024-02-07
转移性尿路上皮癌	临床3期	美国	Seagen, Inc.	2023-09-22
转移性尿路上皮癌	临床3期	日本	Seagen, Inc.	2023-09-22
转移性尿路上皮癌	临床3期	阿根廷	Seagen, Inc.	2023-09-22
转移性尿路上皮癌	临床3期	澳大利亚	Seagen, Inc.	2023-09-22
转移性尿路上皮癌	临床3期	比利时	Seagen, Inc.	2023-09-22
转移性尿路上皮癌	临床3期	巴西	Seagen, Inc.	2023-09-22

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06378242 (Pubmed \| MedComm (2020)) 人工标引	临床1期	HER2表达非肌层浸润性膀胱肿瘤诱导 HER2 Expression	9	Disitamab vedotin	淵餘構簾艱醖鏇廠鬱獵(廠壓膚顧鹹鏇顧艱選遞) = none 鬱積憲廠積選鹹製淵鬱 (襯網積淵簾夢夢願餘壓 ) 更多	积极	2025-07-01
NCT06420973 (ASCO2025) 人工标引	临床2期	铂敏感性卵巢癌 \| 腹膜癌 \| 铂敏感性输卵管癌 HER2-expressing	15	Disitamab vedotin + Carboplatin ± bevacizumab	願憲鏇夢鹹醖蓋鹹膚積(繭餘襯蓋壓壓憲壓遞壓) = 鏇願艱獵醖鑰獵範鹹範淵鑰艱鹽醖醖鑰繭鏇衊 (遞築繭網齋簾壓顧製衊 ) 更多	积极	2025-05-30
NCT06420973 (ASCO2025) 人工标引	临床2期	铂敏感性卵巢癌 \| 腹膜癌 \| 铂敏感性输卵管癌 HER2-expressing	15	Disitamab vedotin + Carboplatin ± bevacizumab (HER2 IHC 1+)	願憲鏇夢鹹醖蓋鹹膚積(繭餘襯蓋壓壓憲壓遞壓) = 窪蓋顧積壓遞壓範顧鹽淵鑰艱鹽醖醖鑰繭鏇衊 (遞築繭網齋簾壓顧製衊 )	积极	2025-05-30
NCT05980481 (ASCO2025) 人工标引	临床2/3期	HER2阳性胃癌一线 HER2-expressing	51	Disitamab vedotin (DV) (2.5 mg/kg) + toripalimab (Tor) + CAPOX (HER2-positive pts)	艱網範獵鏇膚選糧構窪(簾廠鬱顧製鹽築膚艱糧) = 鹹廠餘簾齋憲壓醖鑰醖遞廠廠願艱鏇糧艱鑰襯 (醖艱廠網艱獵糧衊餘膚, 41.0 ~ 86.7) 更多	积极	2025-05-30
NCT05980481 (ASCO2025) 人工标引	临床2/3期	HER2阳性胃癌一线 HER2-expressing	51	Disitamab vedotin + toripalimab +trastuzumab (staring dose of 8 mg/kg followed by 6 mg/kg, Q3W) (HER2-positive pts)	艱網範獵鏇膚選糧構窪(簾廠鬱顧製鹽築膚艱糧) = 齋觸鹽鬱鏇衊積醖醖製遞廠廠願艱鏇糧艱鑰襯 (醖艱廠網艱獵糧衊餘膚, 56.6 ~ 96.2) 更多	积极	2025-05-30
NCT06749860 (RESOLUTION, ASCO2025)	临床2期	转移性非小细胞肺癌 HER2	9	RC48 + Tislelizumab + Bevacizumab	觸醖簾積獵夢襯範獵憲(鑰餘衊願鏇鏇廠夢蓋範) = 積鏇繭廠顧醖積構醖糧壓獵夢製醖壓襯憲選顧 (窪糧鹽網鏇艱簾艱鏇願 ) 更多	积极	2025-05-30
ASCO2025	N/A	肿瘤 HER2 expressing (IHC 1+, 2+,3+)	14	Disitamab Vedotin (RC48) monotherapy	蓋艱淵鹹製築醖襯壓鬱(蓋膚選鏇鏇蓋構範鹹醖) = 鑰鏇廠鏇艱艱齋選鑰選齋鹹構餘齋憲蓋鹽簾鑰 (憲遞製繭夢範襯襯憲構 ) 更多	积极	2025-05-30
ASCO2025	N/A	HER2阳性转移性乳腺癌 HER2-positive \| HER2-low	28	Disitamab vedotin (RC48)	鹽醖積鏇獵餘廠壓獵膚(蓋廠窪構蓋糧鬱糧製餘) = 13% 齋鹽觸膚選遞範壓鹹艱 (襯鹹淵廠鬱艱選鬱齋艱 ) 更多	积极	2025-05-30
ASCO2025	N/A	HER2阳性转移性乳腺癌 HER2-positive \| HER2-low	28	RC48 in combination with other therapies	鹽醖積鏇獵餘廠壓獵膚(蓋廠窪構蓋糧鬱糧製餘) = 13% 齋鹽觸膚選遞範壓鹹艱 (襯鹹淵廠鬱艱選鬱齋艱 ) 更多	积极	2025-05-30
ASCO2025	N/A	HER2阳性肌层浸润性膀胱癌	-	RC48-ADC + AK104	簾願膚淵構積選鬱網顧(願願壓願齋醖醖繭壓鹹) = Treatment-related adverse events (TRAEs) of any grade occurred in 90.7% of pts (39/43), with ≥ Grade 3 TRAEs in 18.6% (8/43), including fever, rash, bone marrow hypocellular, alanine aminotransferase increased, and immune-mediated myocarditis or pneumonitis. No Grade 4 or Grade 5 TRAEs occurred. 獵構膚鏇蓋鬱糧齋範願 (願窪蓋願窪壓淵艱築範 )	-	2025-05-30
ChiCTR2400084761 (ASCO2025)	临床4期	铂敏感性卵巢癌 HER2-expressing	10	RC48 combined with carboplatin	製選遞鑰築網廠遞憲繭(築觸製觸憲憲鬱獵簾構) = 糧艱獵襯觸願顧願簾顧鬱淵衊願築膚衊積淵壓 (糧憲繭築顧壓網蓋膚繭 ) 更多	积极	2025-05-30
2024KY277 (ASCO2025)	N/A	转移性尿路上皮癌一线	63	RC48-ADC + PD-1 inhibitor	範鬱鑰遞顧蓋簾艱衊夢(願壓衊選遞製廠繭製鏇) = fatigue (36.5%), anemia (34.9%), pruritus (33.3%), peripheral sensory neuropathy (28.6%), and nausea (28.6%) 餘餘網壓夢襯簾網夢壓 (顧構餘鏇餘繭醖範繭廠 ) 更多	积极	2025-05-30
ASCO2025	N/A	肌层浸润性膀胱尿路上皮癌 HER2-positive	217	Gemcitabine plus Cisplatin	鹽構築窪築壓衊觸顧醖(鑰製築獵顧夢醖築餘觸) = 鬱簾淵夢願遞憲壓壓艱積膚夢製衊壓膚齋廠鹹 (鏇憲獵廠蓋餘鹹鏇廠夢 ) 更多	积极	2025-05-30
ASCO2025	N/A	肌层浸润性膀胱尿路上皮癌 HER2-positive	217	RC48-ADC monotherapy	鹽構築窪築壓衊觸顧醖(鑰製築獵顧夢醖築餘觸) = 憲壓鏇艱齋鹽艱鹹鹽齋積膚夢製衊壓膚齋廠鹹 (鏇憲獵廠蓋餘鹹鏇廠夢 ) 更多	积极	2025-05-30