A Phase II Study of HB0025 in Combination With Nab-Paclitaxel as First Line Therapy for Unresectable, Locally Advanced or Metastatic Triple-negative Breast Cancer.
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 23
- 主要终点
- The safety and tolerability measures: Incidence,correlation, and severity of adverse events graded according to NCI CTCAE v5.0.
研究概览
简要总结
This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of HB0025 administered with chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form
- •Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
- •No prior systemic therapy for inoperable locally advanced or metastatic TNBC
- •ECOG performance status of 0 or 1
- •Life expectancy ≥ 12 weeks
- •Measurable disease, as defined by RECIST v1.1
排除标准
- •History of severe allergic diseases, allergic history of serious drugs (including unlisted test drugs) or known allergic to any component of this test drug;
- •Previously received any antibody or inhibitor therapy targeting PD-1/PD-L1 or VEGF;
- •Uncontrollable or symptomatic central nervous system (CNS) metastasis;
- •Pregnancy or lactation;
- •Those who have active infection
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
研究组 & 干预措施
HB0025 20mg/kg
干预措施: HB0025 20 mg/kg plus nab-paclitaxel (Drug)
HB0025 10mg/kg
干预措施: HB0025 10 mg/kg plus nab-paclitaxel (Drug)
结局指标
主要结局
The safety and tolerability measures: Incidence,correlation, and severity of adverse events graded according to NCI CTCAE v5.0.
时间窗: From first dose to the time of the disease progression, intolerable toxicity, initiation of new antitumor therapy, loss to follow-up, death, withdrawal of study, completion of 2-year treatment of HB0025, or other reasons, whichever comes first.
Safety profile including adverse events, changes in safety assessment parameters. Incidence, severity, outcome, and correlation to the study drug of all adverse events (AE), treatment-emergent adverse events (TEAE), serious adverse events (SAE) and adverse events of special interest (AESI) assessed according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0; Changes in vital signs, ECOG score, physical examination, electrocardiogram, and laboratory test results before and after study treatment.
次要结局
- ORR per RECIST 1.1 for Part B(Week 3)