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2025年2月7日

适应症Triple-Negative Breast Cancer (TNBC)

干预措施AK112 Nab-paclitaxel Placebo

相关药物AK112 Nab-paclitaxel Placebo

概览

阶段: 3 期
干预措施: AK112
疾病 / 适应症: Triple-Negative Breast Cancer (TNBC)
发起方: Akeso
入组人数: 416
试验地点: 1
主要终点: PFS assessed by IRRC
状态: 招募中
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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).

注册库

clinicaltrials.gov

开始日期

2025年2月7日

结束日期

2028年12月1日

最后更新

上个月

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Akeso

责任方

Sponsor

入排标准

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.