NCT05489679终止1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Incidence of treatment emergent adverse events(TEAEs) from AC682 monotherapy
研究概览
简要总结
This clinical trial is evaluating AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. The main goals of this study are to:
- To evaluate the safety and tolerability of AC682
- To evaluate the pharmacokinetic of AC682
- To evaluate the preliminary anti-tumor activity of AC682
详细描述
This is a Phase I, open-label dose-escalation study of AC682, an orally available estrogen receptor degrader, given as a single agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be ≥18 years-of-age at the time of signing of the ICF
- •Histologically and/or cytologically confirmed advanced estrogen receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer
- •Female patients must be postmenopausal
- •At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or at least 1 predominantly lytic bone lesion in the absence of measurable disease
- •Previously received at least 1 endocrine therapy regimen; concomitant use of cyclin-dependent kinase (CDK) 4/6 inhibitor(s) is acceptable; Previous chemotherapy is not required, but up to 2 prior regimens of cytotoxic chemotherapy is allowed.
- •Patients who have adequate organ functions at baseline
排除标准
- •Treatment with any of the following:
- •systemic anti-cancer chemotherapy, biologic, or hormonal agent from a previous treatment regimen or clinical study within 4 weeks prior to the first dose of AC682; systemic small molecules from a previous treatment regimen or clinical study within 14 days or 5 half-lives (whichever is longer) prior to the first dose of AC682 (at least 10 days must have elapsed between the last dose of such agent and the first dose of study drug)
- •Received radiotherapy (including radioactive isotope therapy) within 4 weeks prior to the first dose of AC682
- •Major surgery (excluding placement of vascular access) within 4 weeks of first dose of AC682
- •With known metastasis to the brain
- •Any condition that impairs a patient's ability to swallow whole pills. Impairment of gastrointestinal function (GI) or GI disease or other condition at baseline that will interfere significantly with the absorption, distribution, or metabolism of AC
- •Use of prophylactic growth factors and blood transfusions ≤14 days prior to the first dose of AC682 and during dose limiting toxicity observation period
研究组 & 干预措施
AC682
Experimental
This arm will evaluate AC682 monotherapy administered in 28-day cycles. The participants will participate in this dose escalation arm.
干预措施: AC682 (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events(TEAEs) from AC682 monotherapy
时间窗: Throughout the study completion, approximately 24 months
Number of adverse events as characterized by type, frequency, seriousness, and relationship to AC682
Incidence of dose limiting toxicities (DLTs) from AC682 monotherapy
时间窗: 28 days
Number of subjects with DLT
次要结局
- To evaluate the preliminary anti-tumor activity of AC682:(Throughout the study completion, approximately 24 months)
- To determine the PK of AC682 after a single dose or multiple doses:(At predefined intervals throughout the study completion, approximately 24 months.)
研究者
研究点 (3)
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