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A Study of YL201 in Patients With Advanced Solid Tumors
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
Summary
This is a phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201 conducted in China and the United States. The study will include 2 parts: a dose escalation part (Part 1) followed by a dose expansion part (Part 2). Part 1 will estimate the MTD/RED(s) in dose escalation cohorts of patients with advanced solid tumors unresponsive to currently available therapies or for whom no standard therapy is available. Part 2 will include patients with selected advanced solid tumor types enrolled at the MTD/RED(s), to better define the safety profile and evaluate the efficacy of YL201.
Official title: A Phase 1A/1B, Multicenter, Nonrandomized, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL201 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
312
Start Date
2022-05-25
Completion Date
2027-10-06
Last Updated
2025-11-10
Healthy Volunteers
No
Conditions
Interventions
YL201
Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle.
YL201
Patients will be treated with YL201 intravenous (IV) (A mg/kg or B g/kg infusion once every 3 weeks (Q3W) as a cycle.
YL201 and atezolizumab
Patients will be treated with YL201 intravenous (IV) infusion (A mg/kg or B mg/kg, up to 200mg) followed by atezolizumab on day 1 of each 21 day cycle
Locations (45)
002
Fair Oaks, California, United States
001
La Jolla, California, United States
003
Lone Tree, Colorado, United States
004
Washington D.C., District of Columbia, United States
005
Boston, Massachusetts, United States
006
Ann Arbor, Michigan, United States
007
Detroit, Michigan, United States
008
St Louis, Missouri, United States
009
Santa Fe, New Mexico, United States
010
New York, New York, United States
011
Chapel Hill, North Carolina, United States
012
Nashville, Tennessee, United States
014
Houston, Texas, United States
015
Irving, Texas, United States
013
San Antonio, Texas, United States
016
Tyler, Texas, United States
017
Fairfax, Virginia, United States
018
Spokane, Washington, United States
019
Tacoma, Washington, United States
020
Edmonton, Alberta, Canada
021
Kelowna, British Columbia, Canada
022
Brampton, Ontario, Canada
023
Toronto, Ontario, Canada
024
Guangzhou, Guangdong, China
025
Zhengzhou, Henan, China
026
Bordeaux, France
027
Dijon, France
028
Marseille, France
029
Nantes, France
030
Paris, France
031
Poitiers, France
032
Saint-Herblain, France
033
Suresnes, France
044
Otwock, Poland
045
Poznan, Poland
034
Barcelona, Barcelona, Spain
035
Barcelona, Barcelona, Spain
039
Leganés, Madrid, Spain
037
Madrid, Madrid, Spain
036
Madrid, Madrid, Spain
038
Moncloa-Aravaca, Madrid, Spain
041
Pozuelo de Alarcón, Madrid, Spain
042
Usera, Madrid, Spain
040
Pamplona, Navarre, Spain
043
Valencia, Valencia, Spain