NCT06767527招募中3 期
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
Akeso1 个研究点 分布在 1 个国家目标入组 416 人开始时间: 2025年2月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 416
- 试验地点
- 1
- 主要终点
- PFS assessed by IRRC
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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
- •Life expectancy of ≥ 3 months.
- •Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-
- •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.
- •Adequate organ function.
排除标准
- •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.
研究组 & 干预措施
AK112
Experimental
AK112 Plus Nab-Paclitaxel
干预措施: AK112 (Drug)
AK112
Experimental
AK112 Plus Nab-Paclitaxel
干预措施: Nab-paclitaxel (Drug)
Placebo
Placebo Comparator
Placebo Plus Nab-Paclitaxel
干预措施: Nab-paclitaxel (Drug)
Placebo
Placebo Comparator
Placebo Plus Nab-Paclitaxel
干预措施: Placebo (Drug)
结局指标
主要结局
PFS assessed by IRRC
时间窗: Up to approximately 2 years
Progression-Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC)
OS
时间窗: Up to approximately 4 years
Overall survival (OS) is defined as the time from randomization to death due to any cause
次要结局
- PFS assessed by investigator(Up to approximately 2 years)
- ORR assessed by IRRC or investigators(Up to approximately 2 years)
- DCR assessed by IRRC or investigators(Up to approximately 2 years)
- DoR assessed by IRRC or investigators(Up to approximately 2 years)
- TTR assessed by IRRC or investigators(Up to approximately 2 years)
- Adverse Events (AEs)(Up to approximately 2 years)
- Cmax and Cmin(Up to approximately 2 years)
- Anti-drug antibodies (ADA)(Up to approximately 2 years)
研究者
研究点 (1)
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