NCT06974929招募中1 期
An Open-Label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 Combination Therapy in Patients With Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This is a study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HRS-6209 combined with other treatment regimens in breast cancer patients, and preliminarily observe its anti-tumor efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-75 years.
- •ECOG performance status 0-
- •Menopausal status.
- •Evidence of radiographic disease progression during or after the last systemic anti-tumor therapy prior to the first study drug administration.
- •At baseline, there must be at least one measurable, extracranial lesion that meets RECIST v1.1 criteria.
- •Expected survival > 3 months.
- •Women of childbearing potential must agree to use highly effective contraceptive measures during the study treatment and for 6 months after the end of treatment. Women of childbearing potential must have a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding.
- •Voluntarily agree to participate in this clinical trial, willing and able to comply with the study visits and procedures, understand the study procedures, and have signed the informed consent form.
排除标准
- •Symptomatic visceral metastasis and other conditions, and the researcher judged that endocrine therapy was not suitable for use.
- •History of clinically serious cardiovascular disease.
- •The ECG examination was abnormal.
- •Patients with clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.
- •The subjects were in acute infection or active tuberculosis and needed drug treatment.
- •The patients received surgery, chemotherapy, immunotherapy and macromolecular targeted therapy within 4 weeks before the first medication.
- •Pregnant and lactating women, or intending to become pregnant during the study.
- •There was a clear history of neurological or mental disorders and the subjects had a history of psychotropic drug abuse or drug abuse.
- •In the course of this study, it is expected to receive other anti-tumor treatments or drugs.
研究组 & 干预措施
HRS-6209 in Combination with Letrozole Group
Experimental
干预措施: Letrozole Tablets (Drug)
HRS-6209 combined with Letrozole and HRS-2189 Group
Experimental
干预措施: Letrozole Tablets (Drug)
HRS-6209 in Combination with Letrozole Group
Experimental
干预措施: HRS-6209 Capsules (Drug)
HRS-6209 combined with Letrozole and HRS-2189 Group
Experimental
干预措施: HRS-6209 Capsules (Drug)
HRS-6209 combined with Letrozole and HRS-2189 Group
Experimental
干预措施: HRS-2189 Tablets (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: 28 days after the first dose.
Maximum tolerated dose (MTD)
时间窗: 28 days after the first dose.
Recommended phase II dose (RP2D)
时间窗: 28 days after the first dose.
Adverse events (AEs)
时间窗: About 1 year.
Serious adverse events (SAEs)
时间窗: About 1 year.
Objective response rate (ORR)
时间窗: About 1 year.
次要结局
- Best overall response (BOR)(About 1 year.)
- Clinical benefit rate (CBR)(About 1 year.)
- Duration of response (DoR)(About 1 year.)
- Progression-free survival (PFS)(About 1 year.)
研究者
研究点 (2)
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