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RECRUITING
NCT05434234
PHASE1/PHASE2

A Study of YL201 in Patients With Advanced Solid Tumors

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

View on ClinicalTrials.gov

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

Interventions

DRUG

YL201

Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle.

DRUG

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.

DRUG

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