Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-Line Therapy
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
Summary
This is a large clinical study carried out at multiple hospitals. Participants will be randomly assigned to one of two groups: one group will receive a new medicine called YL201, and the other group will receive standard chemotherapy chosen by the doctor. The purpose of the study is to see whether YL201 works better and is safer for people with locally advanced or metastatic esophageal squamous cell carcinoma whose first-line treatment has stopped working. The study will also look at how YL201 is processed in the body (Pharmacokinetics), whether it triggers any immune reactions, and whether certain biological markers can help predict how well it works.
Official title: A Randomized, Controlled, Multicenter Phase III Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-Line Therapy (TAISHAN-303)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
440
Start Date
2026-04-30
Completion Date
2028-12-31
Last Updated
2026-03-30
Healthy Volunteers
No
Interventions
YL201
YL201, a B7H3 targeting ADC,administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
Paclitaxel
175 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
Docetaxel
75 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
Irinotecan
125 mg/m², administered on Days 1 and 8 of each cycle, intravenous infusion, every 3 weeks (Q3W).
Locations (1)
101
Jinan, Shandong, China