关西医科大学医院在由第一三共赞助的全球1期临床试验中为首位患者施用DS1025-动脉网

Kansai Medical University Hospital Administers First Patient Dose of DS1025 in Global Phase 1 Clinical Trial Sponsored by Daiichi Sankyo

CISION 等信源发布 2026-10-19 20:44

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First patient worldwide dosed with investigational DS1025, a potential first-in-class CD25 directed antibody drug conjugate being evaluated in patients with advanced solid tumors

全球首位患者接受在研药物DS1025给药，该药是一种潜在的同类首创CD25靶向抗体偶联药物，正在晚期实体瘤患者中进行评估

OSAKA, Japan

日本大阪

，

Oct. 19, 2026

2026年10月19日

/PRNewswire/ -- On August 18, 2026, the Department of New Experimental Therapeutics and Early Phase 1 Drug Development Service at Kansai Medical University Hospital, led by Professor Toshio Shimizu, administered the first worldwide dose of DS1025 to a patient in Japan as part of a global, multicenter .

/PRNewswire/ -- 2026年8月18日，由清水敏夫教授领导的关西医科大学医院新实验疗法与早期一期药物开发服务部门，作为全球多中心试验的一部分，在日本向一名患者给予了DS1025的全球首剂用药。

Phase 1 clinical trial

I期临床试验

sponsored by Daiichi Sankyo. The global first-patient-first-dose milestone makes Kansai Medical University Hospital the first clinical trial site to administer this specifically engineered, investigational, potential first-in-class CD25 directed antibody drug conjugate (ADC) to a patient.

由第一三共赞助。全球首例患者首次给药里程碑的达成，使关西医科大学医院成为首家向患者施用这种专门 engineered、处于研究阶段、潜在同类首创的靶向CD25抗体药物偶联物（ADC）的临床试验机构。

继续阅读

Kansai Medical University Hospital is actively participating in early Phase 1 international cancer drug development, conducting and contributing to several international clinical trials in an area of Japan and Asia where access to First-in-Human (FIH) Phase 1 clinical trials for new drugs has been limited..

关西医科大学医院积极参与早期第一阶段国际抗癌药物研发，在日本及亚洲地区开展并推动多项国际临床试验，填补了该地区在新药首次人体（FIH）第一阶段临床试验资源方面的不足。

Kansai Medical University's early Phase 1 clinical research team, led by Professor Shimizu and 8S inpatient ward nursing staff, celebrating the 'Global First Patient First Dose' milestone.

由清水教授和8S病房护理人员组成的关西医科大学早期I期临床研究团队，庆祝实现“全球首例患者首次给药”里程碑。

DS1025 is an investigational, potential first-in-class CD25 directed ADC that builds on the DXd ADC Technology of Daiichi Sankyo by delivering an immune-oncology optimized cytotoxic payload that works to deplete immunosuppressive T-cells (Treg cells) in the tumor microenvironment and activate the immune system to detect and destroy cancer cells. Treg cells can accumulate within tumors and suppress antitumor immune responses.

DS1025 是一款在研的、潜在的首创 CD25 定向抗体偶联药物（ADC），它在第一三共制药的 DXd ADC 技术平台基础上，通过递送一种经免疫肿瘤学优化的细胞毒性载荷，旨在清除肿瘤微环境中的免疫抑制性 T 细胞（调节性 T 细胞，Treg 细胞），并激活免疫系统以识别和摧毁癌细胞。调节性 T 细胞可在肿瘤内积聚，并抑制抗肿瘤免疫反应。

Because CD25 is highly expressed on Treg cells, including those found in tumor tissue, CD25 is being investigated as a target in cancer immunotherapy..

由于CD25在调节性T细胞（包括肿瘤组织中的调节性T细胞）上高表达，CD25正作为癌症免疫治疗的靶点进行研究。

The multicenter, open-label, first-in-human, dose escalation

多中心、开放标签、首次人体试验、剂量递增

phase 1 trial

一期临床试验

will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of DS1025 in patients with advanced or metastatic solid tumors with disease progression on or after at least one prior line of standard therapy.

将评估DS1025在至少接受过一线标准治疗后疾病进展的晚期或转移性实体瘤患者中的安全性、耐受性、药代动力学和初步疗效。

The trial will evaluate primary endpoints of safety and tolerability, including dose-limiting toxicities and adverse events. Secondary endpoints include pharmacokinetics and immunogenicity. Exploratory endpoints include overall response rate, duration of response, and time to response.

本试验将评估安全性和耐受性主要终点，包括剂量限制性毒性和不良事件。次要终点包括药代动力学和免疫原性。探索性终点包括总缓解率、缓解持续时间和起效时间。

The trial is expected to enroll up to 45 adults with advanced, metastatic, or unresectable solid tumors whose disease has progressed following at least one prior line of standard therapy and for whom no further standard treatment is considered suitable. Clinical sites are planned in Asia, including Japan, and Europe..

该试验预计招募最多45名患有晚期、转移性或不可切除实体瘤的成年患者，这些患者的疾病在至少接受过一线标准治疗后出现进展，且被认为不再适合接受进一步的标准治疗。临床试验中心计划设在亚洲（包括日本）和欧洲。

For Kansai Medical University Hospital, this milestone also reflects its growing role in early-stage international cancer drug development. Through its collaboration with Daiichi Sankyo and other domestic and international partners, Kansai Medical University will continue to contribute to early-stage clinical research and the development of new approaches to cancer treatment..

对关西医科大学医院而言，这一里程碑也反映了其在早期国际抗癌药物开发中日益重要的角色。通过与第一三共及其他国内外合作伙伴的协作，关西医科大学将继续为早期临床研究及癌症治疗新方法的开发做出贡献。

Reference

参考

https://clinicaltrials.gov/study/NCT07681882

About the University

关于大学

Kansai Medical University (KMU) is a private medical university in Osaka, Japan. Originally established in 1928 as Osaka Women's Medical College, KMU became co-educational and adopted its current name in 1954. Guided by its founding spirit of

关西医科大学（KMU）是日本大阪的一所私立医科大学。该校前身为1928年创立的大阪女子医学专门学校，于1954年改为男女同校并启用现名。秉承其建校精神

Jijinshinkyo

自晋新教

—'Benevolence, Compassion, and Empathy'—the university fosters skilled medical professionals across its faculties of Medicine, Nursing, and Rehabilitation. Today, KMU operates an extensive network including four affiliated hospitals, advanced institutes like the Near InfraRed Photo-ImmunoTherapy (NIR-PIT) Research Institute, and global facilities such as the KMU Tower.

“仁爱、慈悲与共情”——该校通过其医学院、护理学院和康复学院，培养技能精湛的医疗专业人才。如今，关西医科大学（KMU）运营着一个庞大的网络，包括四家附属医院、近红外光免疫疗法（NIR-PIT）研究所等前沿研究机构，以及关西医科大学塔等国际化设施。

Approaching its one-hundredth anniversary in 2028, KMU continues to advance medical education, clinical research, and public health..

高丽大学医学院将于2028年迎来百年华诞，届时将继续推进医学教育、临床研究和公共卫生事业的发展。

Website:

网站：

https://www.kmu.ac.jp/en/index.html

Media Contact

媒体联系人

Toshio Shimizu

清水敏雄

+81-72-804-0101

[email protected]