An Open-label, Multi-center, Phase I/Ib Study of IEV407 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 6
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination with endocrine therapy (fulvestrant or letrozole) in patients with advanced hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-negative) breast cancer.
详细描述
This is a first-in-human, open-label, phase I/Ib, multi-center study consisting of a dose escalation part of IEV407 as a single agent (SA) and in combination with endocrine therapy (fulvestrant or letrozole) followed by a dose expansion part in patients with advanced breast cancer (aBC). The study will start with the evaluation of IEV407 as a SA.
Following evaluation of IEV407 in combination with fulvestrant through dose escalation and establishment of a recommended dose and/or dose ranges for optimization (RD/DRO), the study may proceed to the Phase Ib expansion part to evaluate the combination treatment of IEV407 with fulvestrant. If more than one treatment arm is open concurrently in the dose expansion part, a randomization schedule will be employed for patient allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Patients with one of the following indications:
- •Dose escalation (IEV407 single agent and in combination with fulvestrant or letrozole):
- •HR+/HER2- aBC with disease progression on or following, or have been intolerant to, at least one line of endocrine-based therapy in combination with a CDK4/6 inhibitor and at least one additional line of systemic therapy in the unresectable/metastatic setting and not be a candidate for any available standard therapy, in the investigator's judgement.
- •- Dose expansion of IEV407 in combination with fulvestrant: HR+/HER2- aBC with disease progression on or following, or have been intolerant to, endocrine-based therapy in combination with a CDK4/6 inhibitor. They must not have received more than two prior lines of endocrine-based therapy in the unresectable/metastatic setting. Prior cytotoxic chemotherapy and/or antibody-drug conjugate therapies in the unresectable/metastatic setting are not allowed.
排除标准
- •Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values.
- •Impaired cardiac function or clinically significant cardiac disease.
- •Concurrent use of hormone replacement therapy.
- •Women of childbearing potential who are unwilling to use highly effective contraception methods, pregnant or nursing women.
- •For the combination treatment of IEV407 with fulvestrant or letrozole: Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Dose expansion, recommended dose (RD)-1: IEV407 + fulvestrant
IEV407 in combination with fulvestrant
干预措施: Fulvestrant (Drug)
Dose expansion, RD-2 (optional dose optimization): IEV407 + fulvestrant
IEV407 in combination with fulvestrant
干预措施: Fulvestrant (Drug)
Dose expansion, recommended dose (RD)-1: IEV407 + fulvestrant
IEV407 in combination with fulvestrant
干预措施: IEV407 (Drug)
Dose expansion, RD-2 (optional dose optimization): IEV407 + fulvestrant
IEV407 in combination with fulvestrant
干预措施: IEV407 (Drug)
Dose escalation: IEV407 + letrozole
IEV407 in combination with letrozole
干预措施: Letrozole (Drug)
Dose escalation: IEV407 + fulvestrant
IEV407 in combination with fulvestrant
干预措施: Fulvestrant (Drug)
Dose escalation: IEV407 single agent
IEV407 single agent
干预措施: IEV407 (Drug)
Dose escalation: IEV407 + fulvestrant
IEV407 in combination with fulvestrant
干预措施: IEV407 (Drug)
Dose escalation: IEV407 + letrozole
IEV407 in combination with letrozole
干预措施: IEV407 (Drug)