HLX11

DRUG3 trials

Sponsors

Shanghai Henlius Biotech

Conditions

Breast CancerBreast NeoplasmsHER2-positive Breast CancerHealth Adult SubjectsHealthy Male Volunteers

Phase 1

Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects

CompletedNCT04411550

Shanghai Henlius BiotechHealthy Male Volunteers

Start: 2020-07-01End: 2021-07-30Updated: 2022-05-11

Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11

Not yet recruitingNCT07776132

Shanghai Henlius BiotechHealth Adult Subjects

Start: 2026-09-05End: 2027-02-01Target: 60Updated: 2026-08-20

Phase 3

A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer

Active, not recruitingNCT05346224

Shanghai Henlius BiotechBreast Cancer, Breast Neoplasms, HER2-positive Breast Cancer

Start: 2022-04-25End: 2025-12-30Target: 900Updated: 2025-06-10

Related Papers

HLX11, a Proposed Pertuzumab Biosimilar: Pharmacokinetics, Immunogenicity, and Safety Profiles Compared to Three Reference Biologic Products (US-, EU-, and CN-Approved Pertuzumab) Administered to Healthy Male Subjects.

2022-05-205 citations