AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer

Официальное название

A Randomized, Controlled, Multi-center Phase III Clinical Study of AK112 Plus Nab-paclitaxel Versus Placebo Plus Nab-paclitaxel as First-line Treatment for Locally Advanced Unresectable or Metastatic Triple-negative Breast Cancer

Обзор

This multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally advanced or metastatic triple-negative breast cancer (TNBC).

Вмешательства

• Препарат AK112
  AK112 via intravenous (IV) infusion
• Препарат Nab-paclitaxel
  Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle
• Препарат Placebo
  Placebo via IV infusion

Первичные конечные точки

• PFS assessed by IRRC [Срок оценки: Up to approximately 2 years]
• OS [Срок оценки: Up to approximately 4 years]

Вторичные конечные точки (8)

• PFS assessed by investigator [Срок оценки: Up to approximately 2 years]
• ORR assessed by IRRC or investigators [Срок оценки: Up to approximately 2 years]
• DCR assessed by IRRC or investigators [Срок оценки: Up to approximately 2 years]
• DoR assessed by IRRC or investigators [Срок оценки: Up to approximately 2 years]
• TTR assessed by IRRC or investigators [Срок оценки: Up to approximately 2 years]
• Adverse Events (AEs) [Срок оценки: Up to approximately 2 years]
• Cmax and Cmin [Срок оценки: Up to approximately 2 years]
• Anti-drug antibodies (ADA) [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• Voluntarily sign a written informed consent form.
• Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of ≥ 3 months.
• Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2.
• Subjects who have not received prior systemic treatment for advanced breast cancer are eligible for the study.
• Suitable for monotherapy with taxane-based agents.
• At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Adequate organ function.

Критерии исключения

• Patients with locally recurrent disease who are eligible for surgery or radiotherapy.
• History of other malignancies within the past 5 years.
• Active autoimmune disease requiring systemic treatment within the past 2 years.
• Pregnant or breastfeeding women.
• Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.
• Participants with clinically symptomatic pleural effusion, pericardial effusion, or ascites that require repeated drainage.
• Participants with a history of immune deficiency; those who test positive for HIV antibodies; those currently using systemic corticosteroids or other immunosuppressive agents on a long-term basis.
• Individuals with known active tuberculosis (TB), or those suspected of having active TB (who must undergo clinical evaluation for exclusion), and those with known active syphilis infection.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT06767527 · AK112-308

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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