NCT06848699View on ClinicalTrials.gov

A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors

PHASE1/PHASE2RecruitingINTERVENTIONAL

Enrollment

105

Participants

Timeline

Start Date

February 25, 2025

Primary Completion Date

October 30, 2026

Study Completion Date

October 1, 2027

Conditions

Solid Tumor CancerNon Small Cell Lung Cancer

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.

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.

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.

DRUG

HLX43 dose 4

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 5

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

Serplulimab

anti-PD-1 humanized monoclonal antibody injection

Trial Locations (2)

400000

RECRUITING

Second Affiliated Hospital of Army Medical University, PLA, Chongqing

410031

RECRUITING

Hunan Provincial Cancer Hospital, Hunan

All Listed Sponsors

lead

Shanghai Henlius Biotech

INDUSTRY