NCT05654532进行中（未招募）1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC699 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
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs) and clinically significant Grade 3 or higher lab abnormalities following administration of AC699
研究概览
简要总结
This clinical trial is evaluating a drug called AC699 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 AC699 that can be given safely to participants
- Evaluate the safety profile of AC699
- Evaluate the pharmacokinetics of AC699
- Evaluate the effectiveness of AC699
详细描述
This study is a Phase I, first-in-human, open-label dose-escalation study of AC699, an orally bioavailable 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
- Sequential
- 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 (ICF)
- •Adult male and female participants, at least 18 years-of-age at the time of signature of the ICF
- •Female participants must be postmenopausal
- •Confirmed diagnosis of advanced, unresectable, and/or metastatic breast cancer following disease progression on standard treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to standard therapies
- •Histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer
- •Must have received at least 2 prior endocrine or at least 1 prior line of endocrine therapy if combined with CDK4/6 inhibitor
- •Prior chemotherapy is not required, but up to 3 prior regimens of cytotoxic chemotherapy will be allowed in the locally advanced/ metastatic setting
- •At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Appendix B) or at least 1 predominantly lytic bone lesion in the absence of measurable disease
- •Acceptable organ and hematologic function at baseline
- •Life expectancy ≥12 weeks after the start of the treatment
排除标准
- •Treatment with any of the following:
- •Any cytotoxic chemotherapy, investigational agents or other anti-cancer drugs for the treatment of locally advanced or metastatic breast cancer within 14 days prior to the first administration of AC699
- •Radiation therapy within 14 days prior to first study drug administration that did not resolve to tolerable toxicity, or prior irradiation to >25% of bone marrow. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed 7 days prior to study enrollment and no clinically significant toxicities are expected (e.g., mucositis, esophagitis).
- •Major surgery within 21 days prior to the first study drug administration (exception: participants may enroll if fully recovered or without intolerable or clinically significant adverse effects but at least 14 days must have elapsed between major surgery and first study drug administration)
- •Known symptomatic brain metastases requiring the use of systemic corticosteroids ≥10 mg/day prednisone or equivalents. Asymptomatic and treated, or asymptomatic untreated brain metastases are allowed as long as participants are clinically stable. Stable doses of anticonvulsants are allowed.
- •Any condition that impairs a participant'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 AC699.
研究组 & 干预措施
AC699 Dose Escalation
Experimental
Participants will receive an assigned dose of AC699 monotherapy during dose escalation.
One cycle is defined as 28 days.
干预措施: AC699 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant Grade 3 or higher lab abnormalities following administration of AC699
时间窗: Approximately 18 months.
Incidence of dose limiting toxicities (DLTs) from AC699 monotherapy
时间窗: First 28 days of treatment. Cycles are 28 days.
次要结局
- Pharmacokinetic Analysis: Area under the concentration-time curve over the dosing interval (AUC(0-tau))(Up to approximately 28 weeks)
- Pharmacokinetic Analysis: Maximum plasma concentration (Cmax)(Up to approximately 28 weeks)
- Pharmacokinetic Analysis: Terminal elimination half-life (t1/2)(Up to approximately 28 weeks)
- Disease Control Rate (DCR) to assess the anti-tumor activity of AC699 using RECIST 1.1(Approximately 18 months.)
- Pharmacokinetic Analysis: Area under the concentration-time curve over the dosing interval (AUC(0-infinity))(Up to approximately 28 weeks)
- Clinical Benefit Rate (CBR) to assess the anti-tumor activity of AC699 using RECIST 1.1(Approximately 18 months.)
- Objective response rate (ORR) to assess the anti-tumor activity of AC699(Approximately 18 months.)
- Duration of Response (DOR) to assess the anti-tumor activity of AC699 using RECIST 1.1(Approximately 18 months.)
- Progression Free Survival (PFS) to assess the anti-tumor activity of AC699 using RECIST 1.1(Approximately 18 months.)
- Pharmacokinetic Analysis: Time to maximum plasma concentration (tmax)(Up to approximately 28 weeks)
研究者
研究点 (9)
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