NCT06857279View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

April 22, 2025

Primary Completion Date

October 30, 2027

Study Completion Date

July 15, 2028

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.

Trial Locations (2)

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

250117

RECRUITING

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

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY