A Phase 1 Dose Escalation and Expansion Open-label, Multicenter, Study of OP-1250 in Combination With the CDK4/6 Inhibitor Palbociclib in Adult Subjects With Advanced or Metastatic HR-positive, HER2-negative Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Characterization and Incidence in Adverse Events and Serious Adverse Events
研究概览
简要总结
This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.). Purpose of study is to evaluate the safety and pharmacokinetic (PK) profile, and estimate the preliminary anti-tumor activity of the combination in adult subjects with hormone receptor-positive (ER+ / HER2-) advanced or metastatic breast cancer (MBC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed and evaluable locally advanced or metastatic breast cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Must not have received prior oral endocrine or targeted therapy ≤ 2 weeks prior to first dose
- •Must not have received prior chemotherapy, antibody therapy, or investigational therapy ≤ 4 weeks prior to the first dose
- •Prior radiotherapy must have been completed 2 weeks prior to first dose
- •Adequate safety laboratory tests
- •Willingness to use effective contraception
排除标准
- •Gastrointestinal disease
- •Significant hepatic disease
- •Significant cardiovascular disease
- •Significant ECG abnormalities
- •History of pulmonary embolism or high risk of thrombosis
- •Known HIV infection
- •Active infection (requiring antimicrobial therapy)
研究组 & 干预措施
Dose Escalation
This portion of the study will evaluate the safety and pharmacology of a range of OP-1250 doses administered daily with Palbociclib in subjects with advanced and/or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer
干预措施: Palazestrant (Drug)
Dose Escalation
This portion of the study will evaluate the safety and pharmacology of a range of OP-1250 doses administered daily with Palbociclib in subjects with advanced and/or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer
干预措施: Palbociclib (Drug)
Dose Expansion
This portion of the study further explores the clinical activity, safety and pharmacology of OP-1250 in combination with Palbociclib and estimates preliminary data of anti-tumor efficacy
干预措施: Palazestrant (Drug)
Dose Expansion
This portion of the study further explores the clinical activity, safety and pharmacology of OP-1250 in combination with Palbociclib and estimates preliminary data of anti-tumor efficacy
干预措施: Palbociclib (Drug)
结局指标
主要结局
Characterization and Incidence in Adverse Events and Serious Adverse Events
时间窗: From initial inform consent date through 30 days post last dose
Plasma levels of OP-1250 and Palbociclib
时间窗: Up to 9 months
Incidence of Dose Limiting Toxicities
时间窗: From Cycle 1 Day 1 through C1 Day 28
次要结局
未报告次要终点