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ACTIVE NOT RECRUITING
NCT06057922
PHASE1/PHASE2

A Study YL201 in Patients With Selected Advanced Solid Tumors

Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

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