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Sacituzumab Govitecan Plus Bevacizumab in Metastatic TNBC
Sponsor: YING FAN
Summary
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.
Official title: A Phase II Clinical Study of Sacituzumab Govitecan Combined With Bevacizumab for the Treatment of Patients With Metastatic Triple-Negative Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-04-01
Completion Date
2026-12-31
Last Updated
2026-01-22
Healthy Volunteers
No
Conditions
Interventions
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
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
Locations (1)
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China