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RECRUITING
NCT06394414
PHASE1

A Phase 1 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Advanced Solid Tumors

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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