NCT05080842终止1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC682 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (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
- 21
- 试验地点
- 5
- 主要终点
- Incidence of dose limiting toxicities (DLTs)
研究概览
简要总结
This clinical trial is evaluating a drug called 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:
- Identify the recommended dose of AC682 that can be given safely to participants
- To evaluate the side effects of AC682
- To evaluate pharmacokinetics of AC682
- To evaluate the effectiveness of AC682
详细描述
This is a Phase I, first in human, 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
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent form (ICF)
- •Patients must be ≥18 years-of-age at the time of signing of the ICF
- •Female patients must be postmenopausal
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- •Histologically and/or cytologically confirmed advanced estrogen receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer
- •Patients with life expectancy ≥3 months
- •Patients who have adequate organ functions at baseline
- •At least 1 measurable lesion that meets the definition in Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or at least 1 non-target lesion is required.
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)
- •Radiation therapy such as wide-field radiotherapy administered ≤28 days of first dose of AC682
- •Major surgery (excluding placement of vascular access) within 4 weeks of first dose of AC682
- •Known symptomatic brain metastases requiring the use of steroids
- •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. Up to 30 participants will participate in this dose escalation arm.
干预措施: AC682 (Drug)
结局指标
主要结局
Incidence of dose limiting toxicities (DLTs)
时间窗: 28 days (Cycle 1)
Incidence of treatment-emergent adverse events (TEAEs), and clinically significant grade 3 or higher laboratory abnormalities following administration of AC682
时间窗: Through study completion, approximately 18 months
Adverse events will be graded according to NCI CTCAE v5.0.
次要结局
- Progression free survival (PFS) as a measure of anti-tumor activity(Through study completion, approximately 18 months)
- Disease control rate (DCR) as a measure of anti-tumor activity(Through study completion, approximately 18 months)
- Objective response rate (ORR) as a measure of anti-tumor activity(Through study completion, approximately 18 months)
- Clinical benefit rate (CBR) as a measure of anti-tumor activity(Through study completion, approximately 18 months)
- Pharmacokinetic Analysis: maximum plasma concentration (Cmax)(Through study completion, approximately 18 months)
- Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)(Through study completion, approximately 18 months)
- Pharmacokinetic Analysis: area under the concentration-time curve over the dosing interval (AUC(0-tau))(Through study completion, approximately 18 months)
- Pharmacokinetic Analysis: area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf))(Through study completion, approximately 18 months)
- Duration of response (DOR) as a measure of anti-tumor activity(Through study completion, approximately 18 months)
- Pharmacokinetic Analysis: terminal elimination half life (t1/2)(Through study completion, approximately 18 months)
研究者
研究点 (5)
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