MedTrace Logo

A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

NCT06857279 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2026-03-05

No results posted yet for this study

Summary

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Conditions

  • Carcinoma of Head and/or Neck

Interventions

DRUG

HLX43 DOSE 1

Dose 1; 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.

DRUG

HLX43 DOSE 2

Dose 2; 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.

DRUG

HLX43 DOSE 3

Dose 3; 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.

DRUG

HLX43 DOSE 2 + HLX10

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. HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor

DRUG

HLX43 DOSE 3 + HLX10

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. HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor.

DRUG

HLX43 DOSE 2 + HLX10 + HLX07

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. HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor. HLX07 is a recombinant humanized anti-EGFR monoclonal antibody.

DRUG

HLX43 DOSE 3 + HLX10 + HLX07

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. HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor. HLX07 is a recombinant humanized anti-EGFR monoclonal antibody.

Sponsors & Collaborators

Principal Investigators

  • Chaosu Hu, Dr · Fudan University

  • Man Hu, Dr · Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

  • Jinming Yu · handong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

  • Dongmei Ji · Fudan University

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
2025-04-22
Primary Completion
2027-12-30
Completion
2029-01-30

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

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 NCT06857279 on ClinicalTrials.gov