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HLX22

DRUG5 trials

Sponsors

Shanghai Henlius Biotech

Conditions

Gastric CancerGastroesophageal-junction CancerHER2 + Breast CancerHER2-low Hormone Receptor Positive Breast CancerHER2-positive Gastric CancerMonoclonal AntibodySolid Tumor

Phase 1

Evaluate Safety, Tolerability and Pharmacokinetics of HLX22 in Patients With Advanced Solid Tumors Overexpressing HER2
CompletedNCT03916094
Shanghai Henlius BiotechSolid Tumor
Start: 2019-07-31End: 2021-12-27Updated: 2022-05-05

Phase 2

Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer
Active, not recruitingNCT04908813
Shanghai Henlius BiotechGastric Cancer
Start: 2021-09-29End: 2025-12-31Target: 150Updated: 2024-04-15
A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients
RecruitingNCT06832202
Shanghai Henlius BiotechHER2-low Hormone Receptor Positive Breast Cancer
Start: 2025-04-16End: 2029-12-01Target: 50Updated: 2025-06-15
A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients
Not yet recruitingNCT07824869
Shanghai Henlius BiotechHER2 + Breast Cancer
Start: 2026-10-31End: 2029-12-04Target: 90Updated: 2026-09-17

Phase 3

A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
RecruitingNCT06532006
Shanghai Henlius BiotechGastric Cancer, Gastroesophageal-junction Cancer, HER2-positive Gastric Cancer +1
Start: 2024-11-22End: 2028-09-01Target: 550Updated: 2026-02-27

Related Papers

A randomized, double-blinded, international phase III trial comparing HLX22 in combination with trastuzumab and chemotherapy versus trastuzumab and chemotherapy with or without pembrolizumab for first-line treatment for HER2-positive locally advanced or metastatic G/GEJ cancer.
Journal of Clinical Oncology2026-01-10
Updated results of HLX22 plus trastuzumab and XELOX for first-line treatment of human epidermal growth factor receptor 2 (HER2)–positive locally advanced or metastatic gastric/gastroesophageal junction cancer (G/GEJC).
Journal of Clinical Oncology2025-05-281 citations
A randomized, double-blinded, international phase III trial comparing HLX22 in combination with trastuzumab and chemotherapy versus trastuzumab and chemotherapy with or without pembrolizumab for first-line treatment for HER2-positive locally advanced or metastatic G/GEJ cancer.
Journal of Clinical Oncology2025-05-281 citations
HLX22 plus trastuzumab and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer (G/GEJC): Updated results with additional patients.
Journal of Clinical Oncology2025-01-27
A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer.
2024-07-094 citations
HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study.
Journal of Clinical Oncology2024-01-201 citations