RecruitingPhase 2NCT06857279

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

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Sponsor

Shanghai Henlius Biotech

Enrollment

167 participants

Start Date

Apr 22, 2025

Study Type

INTERVENTIONAL

Conditions

Carcinoma of Head and/or Neck

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)

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing HLX43, a new antibody-based therapy, in patients with recurrent or metastatic head and neck squamous cell carcinoma (cancer of the mouth, throat, or voice box) whose cancer has come back or spread despite prior treatment. **You may be eligible if...** - You are aged 18–75 (male or female) - You have confirmed recurrent or metastatic head and neck squamous cell cancer (oropharynx, oral cavity, hypopharynx, or larynx) - Cohort 1: Your cancer has stopped responding to prior systemic treatment - Cohort 2: You are eligible for first-line systemic therapy and have not previously received systemic treatment **You may NOT be eligible if...** - Your cancer is eligible for curative locoregional treatment (surgery or radiation to remove/control the primary tumor) - You have nasopharyngeal cancer - Imaging shows the tumor is invading or wrapping around major blood vessels - You have had another cancer diagnosis within 2 years - You previously had serious immune-related side effects from immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHLX43 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.

DRUGHLX43 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.

DRUGHLX43 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.

DRUGHLX43 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

DRUGHLX43 DOSE 3 + HLX10

DRUGHLX43 DOSE 2 + HLX10 + HLX07

DRUGHLX43 DOSE 3 + HLX10 + HLX07

Locations(2)

Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT06857279