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HLX43

DRUG5 trials

Sponsors

Shanghai Henlius Biotech

Conditions

Advanced or Metastatic Squamous Non-Small Cell Lung CancerAdvanced/Metastatic Malignant Solid TumorsCervical CancerEsophageal CancerHormone Receptor Positive HER-2 Negative Breast CancerOvarian Cancer

Phase 1

A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors
Enrolling by invitationNCT06115642
Shanghai Henlius BiotechAdvanced/Metastatic Malignant Solid Tumors
Start: 2023-11-24End: 2027-11-30Target: 367Updated: 2026-05-29

Phase 2

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors
RecruitingNCT06769152
Shanghai Henlius BiotechCervical Cancer, Ovarian Cancer
Start: 2025-02-20End: 2027-06-05Target: 190Updated: 2026-04-22
A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy
RecruitingNCT06769113
Shanghai Henlius BiotechEsophageal Cancer
Start: 2025-01-26End: 2027-06-05Target: 102Updated: 2026-05-18
A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
RecruitingNCT07459751
Shanghai Henlius BiotechAdvanced or Metastatic Squamous Non-Small Cell Lung Cancer
Start: 2026-05-27End: 2030-01-15Target: 706Updated: 2026-06-01
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
Not yet recruitingNCT07459738
Shanghai Henlius BiotechHormone Receptor Positive HER-2 Negative Breast Cancer
Start: 2026-04-01End: 2027-12-30Target: 60Updated: 2026-03-10

Related Papers

Efficacy and safety of HLX43 (anti–PD-L1 ADC) in patients with advanced non–small cell lung cancer.
Journal of Clinical Oncology2026-05-28
A multicenter, randomized phase 2 study evaluating the efficacy and safety of HLX43 (an anti-PD-L1 ADC) in recurrent/metastatic esophageal squamous cell carcinoma.
Journal of Clinical Oncology2026-01-10
A phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX43 (anti-PD-L1 ADC) in patients with advanced/metastatic solid tumors.
Journal of Clinical Oncology2025-05-281 citations