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A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

NCT06907615 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2025-08-17

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 Advanced Non-small Cell Lung Cancer (NSCLC)

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

HLX43 DOSE 1 (2.0 mg/kg)

Dose 1; 2.0 mg/kg; 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 (2.5 mg/kg)

Dose 2; 2.5 mg/kg; 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.

Sponsors & Collaborators

Principal Investigators

  • Jie He, Dr · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Jie Wang, Dr · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Fred Hirsch, Dr · Mount Sinai Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-09
Primary Completion
2028-04-20
Completion
2028-06-04
FDA Drug
Yes

Countries

  • United States
  • 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 NCT06907615 on ClinicalTrials.gov