A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy
NCT06769113 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2026-05-18
Summary
The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent/Metastatic Esophageal Squamous Cell Carcinomar (ESCC) Failed or Intolerance to Standard First-Line Therapy.
Conditions
- Esophageal Cancer
Interventions
- DRUG
-
HLX43
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Jinming Yu, Dr. · Shandong Cancer Hospital and Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-26
- Primary Completion
- 2026-10-31
- Completion
- 2027-06-05
Countries
- China
Study Locations
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