A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients With Advanced Solid Tumors

A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors

开始日期2025-07-01

申办/合作机构

苏州宜联生物医药有限公司

NCT06629597

/ Recruiting临床3期

A Randomized, Controlled, Multicenter Phase III Clinical Study of YL201 Versus Investigator's Choice of Chemotherapy in Subjects with Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Failed Prior PD-(L)1 Inhibitor and At Least Two Lines of Chemotherapy

This study was designed to compare the efficacy and safety of YL201 with Investigator's choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma who have failed prior PD-(L)1 inhibitor and at least two lines of chemotherapy.

开始日期2024-12-31

申办/合作机构

苏州宜联生物医药有限公司

NCT06612151

/ Recruiting临床3期

A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Compare the Efficacy and Safety of YL201 Versus Topotecan Hydrochloride in Subjects with Relapsed Small Cell Lung Cancer

This study was designed to compare the efficacy and safety of YL201 with Topotecan Hydrochloride in subjects with relapsed small cell lung cancer (SCLC).

开始日期2024-12-17

申办/合作机构

苏州宜联生物医药有限公司

100 项与苏州宜联生物医药有限公司相关的临床结果

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0 项与苏州宜联生物医药有限公司相关的专利（医药）

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项与苏州宜联生物医药有限公司相关的文献（医药）

NATURE MEDICINE

A B7H3-targeting antibody–drug conjugate in advanced solid tumors: a phase 1/1b trial

Article

作者: Hong, Shaodong ; Liu, Zhihua ; Xue, Tongtong ; Lian, Wei ; Zhang, Xian ; Zhao, Shen ; Zhang, Li ; Zheng, Yulong ; Li, Bihui ; Li, Mingjun ; Li, Jingao ; Zhao, Yanqiu ; Fan, Yun ; Huang, Yan ; Liu, Jian ; Qu, Song ; Wu, Lin ; Rosen, Seth ; Yang, Shujun ; Zhuang, Wu ; Cai, Jiaqiang ; Meng, Xiangjiao ; Fang, Wenfeng ; Chin, Steve ; Sommerhalder, David ; Ma, Yuxiang ; Lv, Dongqing ; Zhao, Yuanyuan ; Zhang, Peng ; Luo, Suxia ; Yang, Yunpeng ; Fu, Siqing ; Yang, Kunyu ; Ji, Yinghua ; Zhang, Yang ; Xue, Jinhui ; Zhao, Hongyun

Antibody-drug conjugates (ADCs) have emerged as a transformative modality in the treatment of solid tumors. YL201, a novel B7H3-targeting ADC, leverages a tumor microenvironment activable linker-payload platform, coupled with a novel topoisomerase 1 inhibitor via a protease-cleavable linker. Here we report the findings from a large-scale, global, multicenter, phase 1 trial evaluating the safety, pharmacokinetics and preliminary efficacy of YL201 in patients with advanced solid tumors refractory to standard therapies. The trial included a dose-escalation part (phase 1) and a dose-expansion part (phase 1b). A total of 312 patients were enrolled across multiple tumor types, including extensive-stage small cell lung cancer (ES-SCLC), nasopharyngeal carcinoma (NPC), non-small cell lung cancer, esophageal squamous cell carcinoma and other solid tumors. The maximum tolerated dose was determined to be 2.8 mg kg^-1, and the recommended expansion dose was selected as 2.0 mg kg^-1 and 2.4 mg kg^-1 every 3 weeks. The most common grade 3 or higher treatment-related adverse events included neutropenia (31.7%), leukopenia (29.5%) and anemia (25.0%). Only 4 cases of interstitial lung disease (1.3%) and 1 case of infusion reactions (0.3%) were observed. Encouraging anti-tumor activity was observed, particularly in patients with ES-SCLC (objective response rate (ORR), 63.9%), NPC (ORR, 48.6%), lung adenocarcinoma (ORR, 28.6%) and lymphoepithelioma-like carcinoma (ORR, 54.2%). No significant correlation between B7H3 membrane expression and the ORR was found. YL201 demonstrated an acceptable safety profile and a promising efficacy in heavily pretreated patients with advanced solid tumors, particularly in those with ES-SCLC, NPC or lymphoepithelioma-like carcinoma. Phase 3 clinical trials for patients with SCLC and NPC have already been initiated. ClinicalTrials.gov identifiers: NCT05434234 and NCT06057922 .

1,369

项与苏州宜联生物医药有限公司相关的新闻（医药）

2025-05-26

·同写意

估值51.88亿元！先通医药提交港股IPO

放射疗法临床3期IPO上市批准

2025-05-26

·同写意

全球首个AAV双抗——星眸生物XMVA09注射液II期临床顺利启动！ | 会员动态

临床2期临床1期基因疗法临床结果

2025-05-26

·cn.medilinkthera.com

宜联生物医药与华中科技大学同济医学院附属协和医院建立临床研究战略合作关系

2025年5月23日，苏州宜联生物医药有限公司（以下简称“宜联生物医药”），一家处于临床阶段的生物科技公司，与华中科技大学同济医学院附属协和医院（以下简称“武汉协和医院”）建立临床研究战略合作关系，并在武汉举行了临床研究战略合作签约仪式。武汉协和医院科研处副处长/临床试验机构副主任马鸣、武汉协和医院科研处副处长/临床试验机构办公室主任吴建才、武汉协和医院肿瘤科主任杨坤禹、武汉协和医院胰腺外科教授殷涛、武汉协和医院妇科肿瘤科教授陈叶珊、武汉协和医院临床研究机构办公室、武汉协和医院伦理办公室工作人员、宜联生物医药首席医学官CMO秦续科博士、宜联生物医药临床医学副总裁张先博士等出席本次临床研究战略合作沟通会。宜联生物医药与武汉协和医院有着广泛的临床开发合作，双方累计已就8个正在开展的注册临床研究项目展开合作，涉及乳腺癌、肺癌、食管癌、前列腺癌、鼻咽癌、头颈鳞癌、卵巢癌等7个治疗领域，并就未来可能合作的治疗领域进行了探讨。本次临床研究战略合作会议首先由武汉协和医院科研处副处长/临床试验机构副主任马鸣先生，宜联生物医药首席医学官CMO秦续科博士发表开场致辞。武汉协和医院临床试验机构运营张玉玲女士作开场讲演介绍武汉协和医院及未来规划。宜联生物医药临床医学副总裁张先博士作现场讲演，向各位领导介绍宜联生物医药公司信息及研发管线。在会议沟通交流期间，与会双方达成了众多临床研究战略合作共识。武汉协和医院科研处副处长/临床试验机构办公室主任吴建才先生和宜联生物医药临床医学副总裁张先博士分别代表双方签署了临床研究战略合作协议。武汉协和医院将在医药临床研究项目与宜联生物医药进行密切合作，为宜联生物医药的临床试验研究项目积极输送专业的相关研究人员及其他支持资源，共同加强医药成果转化平台建设及人才交流。双方将在所涉及的医药，医疗，信息化等行业资源进行整合对接，资源共享，融合创新，确保项目能更高效顺利的完成，不断优化医药研发服务平台，造福更多肿瘤患者！

100 项与苏州宜联生物医药有限公司相关的药物交易

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药物(靶点)	适应症	全球最高研发状态

YL-201 ( CD276 x Top I )	晚期恶性实体瘤更多	临床2期
YL-205 ( NaPi-2b x Top I )	晚期恶性实体瘤更多	临床1/2期
YL-202 ( HER3 x Top I )	EGFR突变的非小细胞肺癌更多	临床1期
YL-211 ( c-Met )	晚期恶性实体瘤更多	临床1期
YL-217 ( CDH17 )	晚期恶性实体瘤更多	临床1期