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.
Study ID
NCT07487896
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 23, 2026
Start date
Mar 24, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: YL201
    YL201 monotherapy
  • Active Comparator: Control
    Investigator's choice of Chemotherapy

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to Approximately 36 Months ]

Central Contacts

Related Studies