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NOT YET RECRUITING
NCT07487896
PHASE3

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.

View on ClinicalTrials.gov

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

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).

Locations (1)

101

Jinan, Shandong, China