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 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: YL201-CN-303-01
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is defined as the time from randomization to the event of death from any cause.

  Up to Approximately 36 Months

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  Up to Approximately 36 Months

• Overall response rate (ORR)

  Up to Approximately 36 Months

• Disease control rate (DCR)

  Up to Approximately 36 Months

• Duration of Response (DOR)

  Up to Approximately 36 Months

• Adverse Event (AE)

  Up to Approximately 36 Months

Study Arms (2)

YL201

EXPERIMENTAL

YL201 monotherapy

Drug: YL201

Control

ACTIVE COMPARATOR

Investigator's choice of Chemotherapy

Drug: Paclitaxel; Drug: Docetaxel; Drug: Irinotecan

Interventions

YL201 DRUG

YL201, a B7H3 targeting ADC，administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).

YL201

Paclitaxel DRUG

175 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).

Control

Docetaxel DRUG

75 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).

Control

Irinotecan DRUG

125 mg/m², administered on Days 1 and 8 of each cycle, intravenous infusion, every 3 weeks (Q3W).

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥18 years;
• Voluntary participation in this study with signed informed consent and good compliance.
• ECOG PS score: 0-1;
• estimated life expectancy \>3 months;
• Histologically or cytologically confirmed ESCC with unresectable locally advanced or metastatic disease
• Previously received one line of systemic standard therapy for unresectable locally advanced or metastatic ESCC and experienced disease progression
• Adequate organ function.
• At least one measurable lesion
• Willing to provide biopsy or archived tumor tissue.

You may not qualify if:

• Other malignancies within 5 years prior to first dose or currently concurrent malignancies.
• Prior treatment-related adverse events not resolved to ≤Grade 1 per CTCAE v5.0, except for alopecia (any grade), hyperpigmentation (any grade), peripheral neuropathy (≤ Grade 2), and lymphopenia (≤ Grade 3).
• Major surgery, significant traumatic injury within 4 weeks prior to first dose, or anticipated need for major surgery during study treatment
• Any arterial thromboembolic event within 6 months prior to randomization, or venous thromboembolic events of Grade ≥ 3 according to NCI CTCAE version 5.0.
• Known active tuberculosis (TB). Participants suspected of having active TB must undergo clinical evaluation to rule it out.
• History of immunodeficiency or positive test for human immunodeficiency virus (HIV) antibodies. Participants with known active syphilis infection are also excluded.
• Current active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
• Known allergy to any component of the investigational product; history of severe allergic reactions (e.g., anaphylactic shock); or known history of severe hypersensitivity reactions to other monoclonal antibodies or recombinant proteins, or previous severe infusion reactions.
• Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study period.
• Any disease, medical condition, organ dysfunction, or social/psychological circumstance that, in the investigator's judgment, may interfere with the participant's ability to sign the informed consent form (ICF), compromise cooperation or compliance with study procedures, or affect the interpretation of study results. This includes, but is not limited to, psychiatric disorders, substance/alcohol abuse, or a history of drug abuse.

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead

Study Sites (1)

101

Jinan, Shandong, 250117, China

Location

MeSH Terms

Interventions

Paclitaxel; Docetaxel; Irinotecan

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Central Study Contacts

Medilink Study Team

CONTACT

051262858368; clinicaltrials@medilinkthera.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CN (1)