Emiltatug ledadotin

桂林医科大学第二附属医院  临床试验招募 01 项目癌症：铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌  02 药物特点：HS-20089 03 药物信息：HS-20089是上海翰森生物医药科技有限公司自主研发的1类新药-靶向B7-H4的ADC，适应症为铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌。 联系方式 请您扫码报名或点击“阅读原文”报名！ 联系医生:李碧慧主任  183 7831 6283  地址:桂林市临桂区人民路212号 10号楼14楼 桂林医科大学 第二附属医院肿瘤内科 入选标准 桂林医科大学第二附属医院肿瘤内科正在进行一项“评价注射用HS-20089对比研究者选择的化疗用于治疗铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌的多中心、随机、开放、对照、Ⅲ期临床研究”。注射用HS-20089是上海翰森生物医药科技有限公司自主研发的1类新药-靶向B7-H4的ADC，适应症为铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌。现有一项随机、开放、化疗药对照的多中心Ⅲ期临床研究即将开展，研究拟招募铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌患者468名，为评估HS-20089在中国铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌患者中的有效性和安全性，公开招募符合要求的患者。 该研究目前已经获得国家药品监督管理局以及我院伦理委员会的批准。现公开招募受试者，基本条件如下: 主要入选标准： 为满足参与临床试验要求，筛选的患者需符合以下条件: 1)年满18周岁(≥18周岁)的女性； 2)经组织学确诊的上皮性卵巢癌、输卵管癌或原发性腹膜癌； 3)根据RECIST v1.1，受试者至少有1个靶病灶； 4)美国东部肿瘤协作组(ECOG)体力状况评分(PS)为0~1分，并且在随机前2周没有恶化； 5)自愿参加本次临床试验，理解研究程序且能够书面签署知情同意书。 主要排除标准： 1)原发性铂难治疾病，定义为一线含铂化疗期间或完成后3个月(92天)内出现影像学疾病进展或复发； 2)既往使用过或正在使用以B7-H4为靶点的治疗，例如:AZD-8205、SGN-B7H4V、XMT-1660、BG-C9074、FPA150等； 3)既往使用过或正在使用拓扑异构酶1抑制剂类药物的治疗，包括有效荷载为拓扑异构酶I抑制剂的抗体偶联药物等，例如:托泊替康、伊立替康、德曲妥珠单抗等； 4)存在需要临床干预的胸腔积液/腹腔积液以及心包积液； 5)已知或筛选期检查发现患有中枢神经系统(CNS)转移和/或癌性脑膜炎患者； 6)有严重、未控制或活动性心血管疾病。 您将在本院完成相应的筛选期评估后进行研究药物给药。在研究过程中，可能需要留取您的生物样本(血液及肿瘤组织切片)进行科学研究。 以上为主要的报名条件和研究安排。您是否符合所有入选条件最终将由研究者通过相关医学检查结果判定。 试验中心:桂林医科大学第二附属医院肿瘤内科 如果您想了解本研究更详细的情况，请咨询以下专业人士: 联系人:李碧慧主任18378316283 点击“阅读原文”报名！

Positive Phase 1 data were previously presented in an oral session at ASCO 2026 Emi-Le received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the proposed treatment of patients with locally advanced, recurrent or metastatic ACC with solid histology or high-grade transformation Oct. 19, 2026 -- Servier today announced the first patients have been dosed in the pivotal Phase 2 cohort (EMBLEM-1) of a Phase 1/2 study of Emiltatug Ledadotin (Emi-Le) in solid tumors. EMBLEM-1 is evaluating the antitumor activity and safety of Emi-Le, an investigational antibody drug conjugate (ADC) directed against B7-H4, in aggressive adenoid cystic carcinoma (ACC). "Dosing these first patients marks an important step in advancing Emi-Le as a potential targeted treatment for ACC, a difficult-to-treat cancer with no FDA-approved systemic treatment options," said Becky Martin, PhD, Chief of Medical, Servier Pharmaceuticals. "This milestone also underscores the momentum of Servier's growing oncology portfolio and our commitment to bringing scientific rigor and meaningful innovation to rare cancers where patients face significant unmet need. We look forward to sharing these data with the scientific community." The primary endpoint is objective response rate (ORR)—defined as the percentage of patients who achieve a best overall response of confirmed complete response (CR) or partial response (PR)— per RECIST 1.1. The initiation of EMBLEM-1 is supported by clinical data from a Phase 1 analysis of Emi-Le, which demonstrated a differentiated safety profile and were presented in an oral session at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting. Earlier this year, Emi-Le received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the proposed treatment of patients with locally advanced, recurrent or metastatic ACC with solid histology or high-grade transformation. Emi-Le is an investigational B7-H4-directed Dolasynthen antibody drug conjugate (ADC) with a drug-to-antibody ratio (DAR) of 6 and a proprietary auristatin-F HPA payload designed to provide a controlled bystander effect as demonstrated in preclinical models. Emi-Le is under evaluation in an ongoing Phase 1/2 clinical trial and has not been approved by the FDA, and its safety and effectiveness have not been established. The U.S. Food and Drug Administration has granted Fast Track designations to Emi-Le for the treatment of 1) adult patients with advanced or metastatic triple-negative breast cancer, and 2) advanced or metastatic HER2 low / HER2 negative breast cancer post-topo-1 ADC (including TNBC and certain HR+ breast cancers). It has also received Breakthrough Designation from the FDA for the treatment of patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma with solid histology or high-grade transformation. Adenoid cystic carcinoma (ACC) occurs in the secretory glands, typically in the head and neck, but also in other areas of the body. Globally, more than 200,000 people have ACC. It is diagnosed in roughly four per one million people annually and does not discriminate by ethnicity or lifestyle factors. Today there are no approved or preferred systemic therapies to treat advanced or metastatic ACC; most people are treated with surgery or radiation, but the disease recurs in 50 percent of cases, often becoming more aggressive with metastases in distant areas of the body.1 Servier is a global leader in oncology, governed by a non-profit foundation. Servier approaches innovation with a long-term vision, free of influence from fiduciary responsibilities. Servier invests close to 20% of revenue from brand-name medicines in R&D each year. Servier aspires to advance more targeted therapies by identifying mutations and understanding how these mutations impact cancer and its progression. Servier believes we can serve more people by helping the right patients find the right treatment, at the right time. Servier takes a One Innovation Engine approach to R&D and is actively seeking alliances, partnerships and acquisitions at various stages of the portfolio. References 1 Adenoid Cystic Carcinoma Research Foundation. Accessed May 2026. The content above comes from the network. if any infringement, please contact us to modify.