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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06769113 on ClinicalTrials.gov