A First-In-Human, Phase 1, Dose Escalation Study of SGR-3515 In Participants With Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 14
- 主要终点
- Incidence of Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to learn about the effects of a new study drug, called SGR-3515 that may be a treatment for advanced solid tumors.
详细描述
SGR-3515-101 is a phase 1, first-in-human, single agent, dose-escalation study designed to evaluate the safety, tolerability, dose limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of SGR-3515 and to identify the maximum tolerated dose, recommended phase 2 dose and schedule of SGR-3515, in participants with advanced solid tumors hypothesized to be sensitive to Wee1/Myt1 inhibition and any solid tumors with designated molecular perturbation relevant to DNA damage repair pathway, including but not limited to CCNE1 amplification.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of advanced/metastatic solid tumor
- •Measurable disease per RECIST version 1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Participant must understand and sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures
- •Adequate bone marrow and organ function
- •Women of child-bearing potential (WOCBP) or males must agree to use highly effective contraception for the duration of study and for 90 days after the last dose of study drug
- •Exclusion Criteria
- •Participants with primary Central Nervous System (CNS tumors).
- •Participant has received prior systemic anti-cancer treatments or other investigational agents ≤ 21 days of first dose of study drug, or 5 half-lives, whichever is shorter
- •Participant who has received definitive local control radiation (any dose greater than 50 Gy) < 42 days prior to the first dose of study drug.
- •Participant who has received major surgeries ≤ 21 days prior to first dose of study drug
- •Participants who have not recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade 2 alopecia, peripheral neuropathy and ototoxicity.
- •Participant who has another clinically significant invasive malignancy, as determined by the investigator, ≤ 2 years prior to the first dose
排除标准
- 未提供
研究组 & 干预措施
Dose Escalation
28-day treatment cycle.
干预措施: SGR-3515 (Drug)
结局指标
主要结局
Incidence of Dose Limiting Toxicities (DLTs)
时间窗: Day 1 to Day 28 of the first 28-day dosing cycle.
Incidence of Dose Limiting Toxicities (DLTs)
Recommended phase 2 dose and schedule
时间窗: From day 1 until end of phase I when Maximum Tolerated Dose (MTD) and schedule has been reached and confirmed.
Recommended phase 2 dose and schedule
Incidence and severity of adverse events (AEs)
时间窗: Day 1 to 28 days after the last dose of SGR-3515.
Incidence and severity of adverse events (AEs) per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs); and dose interruptions, dose reductions, dose delays and study drug discontinuation due to AEs.
Incidence of serious adverse events (SAEs)
时间窗: Day 1 to 28 days after the last dose of SGR-3515
Incidence of serious adverse events (SAEs)
次要结局
- Pharmacokinetics Measures: t1/2 of SGR-3515(Day 1 to Day 28 of first 28-day dosing cycle)
- Pharmacokinetics: Measures Cmax and Cmin of SGR-3515(Day 1 to Day 28 of first 28-day dosing cycle)
- Pharmacokinetics Measures: tmax of SGR-3515(Day 1 to Day 28 of first 28-day dosing cycle)
- Pharmacokinetics Measures: Area Under the Curve (AUC) of SGR-3515(Day 1 to Day 28 of first 28-day dosing cycle)
- Efficacy analysis(Day 1 to end of Phase I study)