A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer

Phase 1Not Yet RecruitingNCT07601620

Shanghai Henlius Biotech258 enrolled

Overview

This is a study to compare the similarity in Pharmacokinetics (PK) profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer .

This is a randomized, double-blind, parallel-controlled, multi-center Phase I equivalence study to compare the similarity in PK profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer with a primary tumor \> 2 cm or nodes-positive.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

258

Conditions

HER2 + Breast Cancer

Interventions

HLX319DRUG

HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection)

EU-Phesgo®DRUG

EU-Phesgo® is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Voluntary participation in the clinical study and signed the Informed Consent Form (ICF). * Male or female aged ≥ 18 years old at the time of signing the ICF; * Histologically confirmed invasive breast cancer, stage II-IIIC, Human Epidermal Growth Factor Receptor 2 (HER2) positive confirmed by central laboratory. * Participants agree to undergo surgery while meeting the criteria for surgery after neoadjuvant therapy. * Left ventricular ejection fraction (LVEF) at baseline ≥ 55%. * An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1. * Adequate major organ functions. * Women with child-bearing potential have a negative result of serum pregnancy test at screening period (within 7 days prior to the first dose) or if they are infertile, non- lactating, reproduction-age men and women following highly effective contraceptive measures until 7 months after last dose. Exclusion Criteria: * Stage IV breast cancer, bilateral breast cancer, or multicentric breast cancer. * History of other malignancy within 5 years. * Prior systemic therapy for breast cancer treatment or radiotherapy. * Patients with a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) who have received systemic therapy or radiotherapy to the ipsilateral breast. * Patients who have undergone excision biopsy of the primary tumor and/or axillary lymph nodes or lymph node dissection. * Have severe heart disease or medical conditions. * Participants with viral hepatitis or those with autoimmune hepatitis, sclerosing cholangitis, or liver cirrhosis. * Human Immunodeficiency Virus (HIV) infection, HIV antibody positive. * Daily use of corticosteroid treatment is required. * Sensitivity to any study medications or any of its ingredients or excipients. * Participants who underwent any major surgery within 28 days prior to the first dose. Or participants who have received local radiotherapy, radiofrequency ablation, or interventional therapy within 2 weeks prior to the first dose. * Received another interventional clinical trial therapy within 4 weeks prior to enrollment in the study, or intentionally participated in another interventional clinical trial during the entire study period. * Severe, uncontrolled systemic diseases that may currently interfere with the therapeutic plan. * Any other conditions which are inappropriate for the study in the opinion of the investigator.

Outcomes

Primary Outcomes

Peak concentration (Cmax)

Peak concentration after a single drug administration in Cycle 1.

Time frame: up to 180 days

Area under the serum drug concentration-time curve from 0 to 21 days (AUC0-21d)

Area under the serum drug concentration-time curve from 0 to 21 days after a single drug administration in Cycle 1.

Time frame: up to 180 days

Steady-state peak concentration (Cmax,ss)

The steady-state peak concentration after multiple doses administration in Cycle 4.

Time frame: up to 180 days

Steady-state area under the serum drug concentration-time curve within a dosing interval (AUCss)

Steady-state area under the serum drug concentration-time curve within a dosing interval after multiple doses administration in Cycle 4.

Time frame: up to 180 days

Secondary Outcomes

Trough concentration (Ctrough)

Trough concentration after a single dose administration

Time frame: up to 180 days

Area under the serum drug concentration-time curve from time 0 to infinity (AUC0-inf)

Area under the serum drug concentration-time curve from time 0 to infinity after a single dose administration

Time frame: up to 180 days

Percentage of extrapolated area in the total AUC (%AUCex)

Percentage of extrapolated area in the total AUC after a single dose administration

Time frame: up to 180 days

Central Contacts

Qi Jin

CONTACT

86 159 5516 0489 Qi_jin@henlius.com

Data from ClinicalTrials.gov

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