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A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
Summary
This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of three parts. Part 1 is dose-escalation part. In part 1, the safety and tolerability of YL211 in patients with selected advanced solid tumors will be evaluated and the MTD and RED will be determined. Part 2 is backfill enrollment part. We will further estimate the safety and efficacy of YL211 in patients with selected adcance tumor to select the RED(s) of YL211. Part 3 is dose-expansion part. In this part, we will further evaluate the safety and efficacy of YL211 at the MTD/RED(s) in patients with selected advanced solid tumors YL211 will be administered intravenously (IV) until criteria of treatment discontinuation are met.
Official title: A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
155
Start Date
2024-05-01
Completion Date
2029-04-07
Last Updated
2026-01-02
Healthy Volunteers
No
Conditions
Interventions
YL211
Patients will be treated with YL211 intravenous (IV) infusion.
Locations (21)
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Sarah Cannon Research Institute (SCRI) at HealthONE
Denver, Colorado, United States
Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven
North Haven, Connecticut, United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States
Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office
Sarasota, Florida, United States
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, United States
University of Cincinnati Vontz Center for Molecular Studies
Cincinnati, Ohio, United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology - Houston
Houston, Texas, United States
NEXT Oncology - Dallas
Irving, Texas, United States
NEXT San Antonio
San Antonio, Texas, United States
Gosford Hospital
Gosford, New South Wales, Australia
One Clinical Research - Nedlands
Nedlands, Western Australia, Australia
Monash Health
Melbourne, Australia
Princess Margaret Hospital
Toronto, Toronto, Canada
The Ottawa Hospital - General Campus
Ottawa, Canada
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Wenzhou Medical University - The First Affiliated Hospital
Wenzhou, Zhejiang, China
West China Hospital, Sichuan University
Chengdu, China
Sun Yat-sen University Cancer Center
Guangzhou, China