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A Study YL201 in Patients With Selected Advanced Solid Tumors
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
Summary
This is A Multicenter, Open-Label, Phase 1/2 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients with Selected Advanced Solid Tumors. The study will include 2 parts: Phase 1 dose expansion stage (Part 1) followed by a Phase 2 stage with expanded sample size (Part 2). Part 1 will estimate the RP2D in dose expansion cohorts of patients with not linited to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), nasopharyngeal carcinoma (NPC), esophageal squamous cell carcinoma (ESCC), metastatic castration-resistant prostate cancer (mCRPC), head and neck squamous cell carcinoma (HNSCC), sarcoma, ductal adenocarcinoma of pancreas (PDAC), hepatocellular carcinoma (HCC), biliary tract cancer (BTC), etc.. Part 2 will include patients with selected advanced solid tumor types enrolled at the RP2D to further assess the efficacy and safety of YL201.
Official title: A Multicenter, Open-Label, Phase 1/2 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With Selected Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
990
Start Date
2023-09-22
Completion Date
2028-10
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
YL201 for Injection
Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle; and at dose levels of 1.0 mg/kg and 1.2 mg/kg administered on Days 1 and 8 of each Q3W treatment cycle.
Locations (52)
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of USTC
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Dongguan People's Hospital
Dongguan, Guangdong, China
The Frist People's Hospital of Foshan
Foshan, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Yuebei People's Hospital
Shaoguan, Guangdong, China
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
Liuzhou Worker's Hospital
Liuchow, Guangxi, China
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
Jiangyin People's Hospital
Wuxi, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Jiangxi Cancer Hospital (Jiangxi Second People's Hospital)
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Shanxi Cancer Hospital
Datong, Shanxi, China
The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University
Xian, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Huaxi, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China