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A Phase 1 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Advanced Solid Tumors
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
Summary
This is a phase 1, multicenter, open-label stydy to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Serplulimab with or without Platinum-based Chemotherapy in Selected Subjects with Advanced Solid Tumors conducted in China. The study will include 2 parts: a dose escalation part (Part 1) followed by a cohort expansion part (Part 2). Part 1 will estimate the safety, tolerability and MTD/RED(s) of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors. Part 2 will estimate the efficacy of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors.
Official title: A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Serplulimab with or Without Platinum-based Chemotherapy in Selected Subjects with Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
162
Start Date
2024-04-17
Completion Date
2030-04-29
Last Updated
2025-02-24
Healthy Volunteers
No
Conditions
Interventions
YL201
YL201 (High dose, medium dose and low dose; Q3W) in Combination with Serplulimab (4.5mg/kg; Q3W) with or without Platinum(70 mg/m2; Q3W)-based Chemotherapy.
Locations (30)
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijinig, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China
The First Affiliated Hospital of Hainan Medical College
Haikou, Hainan, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Provincial Cancer Hospital
Wuhan, Hubei, China
Union Hospital Tongji Medical College HuaZhong University of Science Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changhua, Jilin, China
Liaoning Provincial Cancer Hospital
Shenyang, Liaoning, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Linyi Central Hospital
Linyi, Shandong, China
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Sichuan, Sichuan, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China