HD201

DRUG2 trials

Sponsors

Prestige Biopharma Limited

Conditions

HER2 Positive Breast CancerHealthy Volunteers

Phase 1

A Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects

CompletedNCT03776240

Prestige Biopharma LimitedHealthy Volunteers

Start: 2019-04-01End: 2019-08-19Updated: 2026-07-07

Phase 3

A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients

CompletedNCT03013504

Prestige Biopharma LimitedHER2 Positive Breast Cancer

Start: 2018-02-19End: 2022-01-13Updated: 2024-11-06

Related Papers

Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting.

2023-01-312 citations

Efficacy of HD201 vs Referent Trastuzumab in Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting

JAMA Oncology2022-03-0313 citations

TROIKA‐1: A double‐blind, randomized, parallel group, study aimed to demonstrate the equivalent pharmacokinetic profile of HD201, a potential biosimilar candidate to trastuzumab, versus EU‐Herceptin<sup>®</sup> and US‐Herceptin<sup>®</sup> in healthy male subjects

Pharmacology Research & Perspectives2021-07-265 citations