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

Официальное название

A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Phesgo® Biosimilar HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer

Обзор

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 .

Подробное описание

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.

Вмешательства

• Препарат HLX319
  HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection)
• Препарат EU-Phesgo®
  EU-Phesgo® is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection)

Первичные конечные точки

• Peak concentration (Cmax) [Срок оценки: up to 180 days]
• Area under the serum drug concentration-time curve from 0 to 21 days (AUC0-21d) [Срок оценки: up to 180 days]
• Steady-state peak concentration (Cmax,ss) [Срок оценки: up to 180 days]
• Steady-state area under the serum drug concentration-time curve within a dosing interval (AUCss) [Срок оценки: up to 180 days]

Вторичные конечные точки (12)

• Trough concentration (Ctrough) [Срок оценки: up to 180 days]
• Area under the serum drug concentration-time curve from time 0 to infinity (AUC0-inf) [Срок оценки: up to 180 days]
• Percentage of extrapolated area in the total AUC (%AUCex) [Срок оценки: up to 180 days]
• Time to peak concentration (Tmax) [Срок оценки: up to 180 days]
• Elimination half-life (T1/2) [Срок оценки: up to 180 days]
• Total clearance (CL/F) [Срок оценки: up to 180 days]
• Terminal phase distribution volume (Vz/F) [Срок оценки: up to 180 days]
• Mean residence time (MRT) [Срок оценки: up to 180 days]
• Steady-state trough concentration (Ctrough,ss) [Срок оценки: up to 180 days]
• Average steady-state concentration (Caverage,ss) [Срок оценки: up to 180 days]
• Steady-state time to peak concentration (Tmax,ss) [Срок оценки: up to 180 days]
• Elimination half-life (T1/2,ss) [Срок оценки: up to 180 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07601620 · HLX319-BC001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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