drugset / Trial / NCT07487896

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

NCT07487896

Phase 3 Recruiting 440 enrolled MediLink Therapeutics (Suzhou) Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-03-24
Primary completion
2028-04-30
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Comparator Irinotecan Small molecule 125 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject YL201 Other / unclassified Intravenous