A Phase II Study of AK117/AK112 in Combination With Chemotherapy for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events (AEs)
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 AK117/AK112 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
- Parallel
- 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
- •Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
- •No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
- •Eligible for taxane monotherapy
- •A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 5 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity.
- •Eastern Cooperative Oncology Group performance status of 0 or 1
- •Measurable disease as defined by RECIST v1.1
- •Adequate hematologic and end-organ function
排除标准
- •Known central nervous system (CNS) disease, except for asymptomatic CNS metastases
- •Leptomeningeal disease
- •Pregnancy or lactation
- •History of autoimmune disease
- •Prior allogeneic stem cell or solid organ transplantation
- •Positive test for human immunodeficiency virus
- •Active hepatitis B or hepatitis C
- •Receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment
研究组 & 干预措施
cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel)
Subjects receive AK117 and AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
干预措施: AK117 (Drug)
cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel)
Subjects receive AK117 and AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
干预措施: AK112 (Drug)
cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel)
Subjects receive AK117 and AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
干预措施: Nab paclitaxel (Drug)
cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel)
Subjects receive AK117 and AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
干预措施: paclitaxel (Drug)
cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel)
Subjects receive AK117 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
干预措施: AK117 (Drug)
cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel)
Subjects receive AK117 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
干预措施: Nab paclitaxel (Drug)
cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel)
Subjects receive AK117 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
干预措施: paclitaxel (Drug)
cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)
Subjects receive AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
干预措施: AK112 (Drug)
cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)
Subjects receive AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
干预措施: Nab paclitaxel (Drug)
cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)
Subjects receive AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
干预措施: paclitaxel (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Up to approximately 2 years
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Objective response rates (ORR)
时间窗: Up to approximately 2 years
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1
次要结局
- Progression-free survival (PFS)(Up to approximately 2 years)
- Duration of response (DOR)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Disease control rate (DCR)(Up to approximately 2 years)
- Time to response (TTR)(Up to approximately 2 years)