NCT06450106招募中1 期
A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
SURGE Therapeutics4 个研究点 分布在 2 个国家目标入组 18 人开始时间: 2025年5月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
研究概览
简要总结
A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
详细描述
A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 18 years or older at time of informed consent.
- •Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening.
- •Grade Group 2-
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 at Screening.
- •Have adequate organ and bone marrow function at screening.
- •Able to understand and be willing to sign an Institutional Review Board/Ethics Committee-approved written informed consent document
排除标准
- •Have an invasive malignancy, other than the disease under study.
- •Anticipated to require the use of a drain after radical prostatectomy.
- •Received any other anticancer therapy (e.g., including but not limited to chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, radiation therapy, intravesical therapy ) within 28 days.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition as those used in the STM-416p formulation including poloxamer 407 and sodium hyaluronate.
- •History of allogeneic organ transplant.
- •History of primary immunodeficiency.
- •QTc interval >470 msec at Screening.
研究组 & 干预措施
STM-416p
Experimental
STM-416p
干预措施: STM-416p (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
时间窗: 21 Days
Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Time on trial up to 90 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
次要结局
- Assess surgical wound healing(Day 7, Day 21)
- Pharmacodynamics of STM-416p in blood circulating cytokines(Day 0, post 24 hours, post 48 hours, post 21 days)
- Pharmacokinetics of STM-416p(Day 0, post 24 hours, post 48 hour)
研究者
研究点 (4)
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