A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients Undergoing Breast-Conserving Cancer Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to patients undergoing breast-conserving cancer surgery. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts.
详细描述
This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to patients undergoing breast-conserving cancer surgery. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts, with 3 to 6 patients enrolled at each dose level, and a minimum of 6 patients enrolled at the highest dose level, for a total of approximately 12-18 patients in the dose escalation portion of the study.
SRG-514 doses will be escalated based on safety and potential dose-limiting toxicities (DLTs) within the 14-day period following SRG-514 administration. Patients who do not complete the DLT period for reasons other than study drug related toxicity would be considered non-evaluable for DLT assessment and may be replaced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Aged 18 years or older
- •Body weight >50kg
- •Have a history of histologically confirmed diagnosis of breast carcinoma or ductal carcinoma in situ, except inflammatory breast cancer.
- •Plan to undergo breast-conserving surgical treatment of breast cancer with curative intent. Adjuvant or neoadjuvant chemotherapy is allowed.
- •Have Eastern Cooperative Oncology Group (ECOG) Performance Status <2
- •Have adequate organ and bone marrow function at screening
排除标准
- •Any known contraindication to ketorolac or other non-steroidal anti-inflammatory drugs (NSAIDs)
- •Patients anticipated to require the use of a drain after breast-conserving surgery (BCS)
- •Patients undergoing immediate reconstruction surgery, intraoperative radiation therapy (IORT) or brachytherapy requiring the placement of balloons or catheters during the lumpectomy procedure.
研究组 & 干预措施
SRG-514
SRG-514
干预措施: SRG-514 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Time on trial up to 60 days
Incidence of serious adverse events (SAEs), and adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
时间窗: 14 days
Incidence of dose-limiting toxicities (DLTs) over the first 14-days of study treatment
次要结局
- Wound healing(Day 0, Day 1, Day 2, Day 7, Day 14, Day 60)
- Pharmacodynamics of SRG-514(Day 0, Day 1, Day 2, Day 7, Day 14)
- Pharmacokinetics of SRG-514(Day 0, Day 1, Day 2)