Sacituzumab Govitecan Plus Bevacizumab in Metastatic TNBC

Официальное название

A Phase II Clinical Study of Sacituzumab Govitecan Combined With Bevacizumab for the Treatment of Patients With Metastatic Triple-Negative Breast Cancer

Обзор

This is a single-arm, multicenter, Phase II clinical study aiming to explore the efficacy and safety of Sacituzumab Govitecan combined with Bevacizumab as a second-line or later treatment for patients with metastatic triple-negative breast cancer (mTNBC). The study will be conducted in 6-8 centers in China. The study is divided into two phases: a Safety Run-in Phase and a Dose Expansion Phase. In the Safety Run-in Phase (3-12 patients), three dose levels are planned to determine the recommended dose. The starting dose (Level 1) is Sacituzumab Govitecan 10 mg/kg (Days 1, 8) plus Bevacizumab 7.5 mg/kg (Day 1) every 21 days. Based on the occurrence of Dose-Limiting Toxicities (DLT) in the first cycle, the Safety Monitoring Committee (SMC) will decide whether to continue the current dose or de-escalate to Level 2 (Sacituzumab Govitecan 10 mg/kg + Bevacizumab 5 mg/kg) or Level 3 (Sacituzumab Govitecan 7.5 mg/kg + Bevacizumab 5 mg/kg). In the Dose Expansion Phase, 40-50 patients will be enrolled to receive the combination therapy at the recommended dose determined in the run-in phase. Efficacy will be evaluated every 2 cycles according to RECIST 1.1, and safety will be assessed continuously until disease progression or intolerable toxicity.

Вмешательства

• Препарат Sacituzumab Govitecan (SG)
  Administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle. In the Safety Run-in phase, the starting dose is 10 mg/kg, with a potential de-escalation to 7.5 mg/kg based on Dose-Limiting Toxicity (DLT). In the Expansion phase, patients receive the determined recommended dose
• Препарат Bevacizumab
  Administered by intravenous infusion on the first day of each 21-day cycle. In the safety trial phase, the starting dose is 7.5 mg/kg and can be reduced to 5 mg/kg depending on dose-limiting toxicity (DLT). During the expansion phase, patients receive the determined recommended dose

Первичные конечные точки

• Progression-Free Survival [Срок оценки: From start of treatment until disease progression or death, assessed up to approximately 32 months (based on study completion date of Dec 2026)]
• Incidence and Severity of Adverse Events (Safety) [Срок оценки: From start of treatment through 90 days after the last dose of study drug.]

Вторичные конечные точки (6)

• Objective Response Rate [Срок оценки: From start of treatment until disease progression or intolerance, assessed every 2 cycles, assessed up to approximately 32 months]
• Overall Survival [Срок оценки: From start of treatment until death, assessed up to approximately 32 months]
• Disease Control Rate [Срок оценки: From start of treatment until disease progression or intolerance, assessed up to approximately 32 months]
• Duration of Response [Срок оценки: From date of first response until disease progression or death,assessed up to approximately 32 months]
• 6-month Progression-Free Survival Rate [Срок оценки: At 6 months after treatment initiation]
• 6-month Overall Survival Rate [Срок оценки: At 6 months after treatment initiation]

Критерии участия

Критерии включения

• Patients aged > 18 years.
• Pathologically confirmed recurrent or metastatic Triple-Negative Breast Cancer (TNBC).
• ER and PR negativity is defined as < 10% expression in tumor cells. HER2 negativity is defined as IHC 0, 1+, or IHC 2+ with FISH negative. Must have received at least one prior systemic therapy in the metastatic setting.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of more than 3 months.
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Adequate organ function.
• Sufficient washout period before screening (3 weeks from last chemotherapy, 4 weeks from last targeted therapy)

Критерии исключения

• Prior treatment with Sacituzumab Govitecan or Bevacizumab.
• Uncontrolled central nerve
• Presence of other primary malignancies.
• Severe infection, severe cardiac disease, autoimmune disease, or other conditions deemed unsuitable for anti-tumor therapy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT07359404 · Y-Gilead2024-PT-0284

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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