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A Study of YL242 in Subjects With Advanced Solid Tumors
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
Summary
This is a multicenter, open-label study to evaluate the safety and tolerability of YL242 monotherapy and combination in participants with advanced solid malignant tumors.
Official title: A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL242 Monotherapy and Combinations in Advanced Solid Tumors.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
424
Start Date
2025-09-22
Completion Date
2028-11
Last Updated
2025-12-24
Healthy Volunteers
No
Conditions
Interventions
YL242
The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes.
YL242; Pembrolizumab
The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes. Pembrolizumab will be administered subsequent to YL242.
YL242; 5-FU; LV
The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes. LV and 5-FU will be sequentially administered following YL242.
YL242; Pembrolizumab; 5-FU
The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. YL242 will be administered via Intravenous (IV) Infusion. Pembrolizumab and 5-FU will be administered in sequence after YL242.
Locations (15)
US-201
New Haven, Connecticut, United States
US-202
Sarasota, Florida, United States
US-204
Boston, Massachusetts, United States
US-206
Grand Rapids, Michigan, United States
US-205
Nashville, Tennessee, United States
US-203
Houston, Texas, United States
US-207
San Antonio, Texas, United States
AUS-101
Liverpool, New South Wales, Australia
AUS-102
Darlinghurst, Victoria, Australia
AUS-104
Fitzroy, Victoria, Australia
AUS-103
Heidelberg, Victoria, Australia
AUS-105
Nedlands, Western Australia, Australia
CN-303
Harbin, Heilongjiang, China
CN-301
Shanghai, Shanghai Municipality, China
CN-302
Hangzhou, Zhejiang, China