NCT07115485View on ClinicalTrials.gov

Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 20, 2025

Primary Completion Date

August 30, 2027

Study Completion Date

September 30, 2028

Conditions
Gastric or Gastroesophageal Junction Adenocarcinoma
Interventions
DRUG

HLX43 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. DOSE 1 is 2.0mg/kg

DRUG

HLX43 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. DOSE 1 is 2.5mg/kg

DRUG

HLX43 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. DOSE 1 is 3.0mg/kg

Trial Locations (1)

Unknown

Beijing Cancer Hospital, Beijing

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY