Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.

Официальное название

A Randomized, Controlled, Open-label, Multicenter, Phase Ш Clinical Study of the Efficacy and Safety of KN026 in Combination With HB1801 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.

Обзор

This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the first-line treatment of subjects with HER2-positive recurrent or metastatic breast cancer. The statistical assumption for this study is superiority. The primary study endpoint was PFS as assessed by Blinded Independ Review Committee (BIRC).

Подробное описание

The purpose of this study is to assess the efficacy and safety of KN026 combined with HB1801 versus trastuzumab combined with pertuzumab and docetaxel as first-line treatment for HER2-positive recurrent or metastatic breast cancer. This study will establish an independent data monitoring committee (IDMC) to conduct safety assessments after approximately 20 subjects in the treatment group complete the first cycle of treatment. During the safety assessment period, the study will continue to enroll subjects, and safety review meetings will be at 1 year of randomization in the first subject. In addition, the IDMC plans to conduct one interim analysis of efficacy during the study period.

The primary study hypotheses are that the combination of KN026 combined with HB1801 is superior to trastuzumab combined with pertuzumab and docetaxel with respect to: Progression-free Survival (PFS) as assessed by the BIRC per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

Вмешательства

• Препарат Recombinant Humanized Bispecific antibody against HER2，KN026
  IV infusion
• Препарат HB1801
  IV infusion
• Препарат Pertuzumab
  840 mg loading dose followed by 420 mg per cycle, D1 Q3W, IV infusion
• Препарат Trastuzumab
  8 mg/kg loading dose followed by 6 mg/kg per cycle, D1 Q3W, IV infusion
• Препарат Docetaxel
  75 mg/m\^2, D1 Q3W, IV infusion

Первичные конечные точки

• Free-progression survival (PFS) as evaluated by BIRC (RECIST1.1). [Срок оценки: Up to approximately 4 years]

Вторичные конечные точки (9)

• PFS (investigator assessment, RECIST1.1) [Срок оценки: Up to approximately 4 years]
• Overall survival (OS) [Срок оценки: Up to approximately 4 years]
• Objective response rate (ORR) [Срок оценки: Up to approximately 4 years]
• Disease control rate (DCR) [Срок оценки: Up to approximately 4 years]
• Duration of response (DoR) [Срок оценки: Up to approximately 4 years]
• Frequency and severity of TEAE and SAE [Срок оценки: Up to approximately 4 years]
• Concentration of KN026 in serum [Срок оценки: Up to approximately 4 years]
• Concentration of HB1801 in serum [Срок оценки: Up to approximately 4 years]
• Incidence of KN026 Anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable) [Срок оценки: Up to approximately 4 years]

Критерии участия

Критерии включения

• Voluntarily enrolled in this study and signed an informed consent form (ICF).
• Age ≥ 18 years.
• Recurrent or metastatic breast cancer confirmed by histology and/or cytology.
• Latest tumor tissue sample confirmed as HER2 positive by central laboratory testing.
• No prior systemic chemotherapy and/or HER2-targeted therapy for recurrent or metastatic breast cancer.
• Eastern Cooperative Oncology Group (ECOG) physical status score of 0 - 1.
• Presence of lesion (RECIST 1.1).
• Adequate organ and bone marrow function

Критерии исключения

• Ineligible for any of the agents on the study
• Untreated or unstable parenchymal metastases, spinal cord metastases or compression, or carcinomatous encephalitis.
• Pregnant or lactating women.
• Presence of other circumstances that may interfere with the subject's participation in the study procedures or are inconsistent with the maximum benefit of the subject's participation in the study or affect the results of the study: e.g., history of mental illness, drug or substance abuse, any other disease or condition of clinical significance, etc.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Clinical Trials Information Group — Пекин

Идентификаторы

NCT: NCT05838066 · KN026-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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