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

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)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	YL201	YL201, a B7H3 targeting ADC，administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
DRUG	Paclitaxel	175 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
DRUG	Docetaxel	75 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
DRUG	Irinotecan	125 mg/m², administered on Days 1 and 8 of each cycle, intravenous infusion, every 3 weeks (Q3W).

Timeline

• Start date: 2026-04-30
• Primary completion: 2028-04-30
• Completion: 2028-12-31
• First posted: 2026-03-23
• Last updated: 2026-03-30

Locations

1 site across 1 country: China