A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 31
- 主要终点
- Safety of SNV1521
研究概览
简要总结
This study is testing a new medicine, SNV1521, for people with advanced cancers. The researchers want to find out if SNV1521 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the most effective and safe one. They are also investigating whether it can be combined with other cancer therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Advanced or metastatic solid tumor malignancy
- •Evaluable or Measurable disease (RECIST 1.1 Criteria).
- •ECOG Performance Status 0 or
- •Life expectancy > 3 months
排除标准
- •History of other malignancy within the past 2 years
- •Prior diagnosis of Myelodysplastic syndrome or Acute Myeloid Leukemia
- •Significant cardiovascular disease within 6 months
- •Significant gastrointestinal disease
- •HIV infection with a CD4+ T-cell count < 200 cells/μL and/or a detectable viral load
- •Liver dysfunction
研究组 & 干预措施
Combination 1 Dose Expansion for mCRPC or mCSPC
干预措施: Abiraterone (Drug)
Monotherapy Dose Expansion
干预措施: SNV1521 (Drug)
Combination Dose Escalation
干预措施: DB-1310 (Drug)
Dose Expansion for Ovarian, Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
干预措施: SNV1521 (Drug)
Monotherapy Dose Escalation
干预措施: SNV1521 (Drug)
Dose Expansion for Breast Cancer
干预措施: SNV1521 (Drug)
Dose Expansion for Pancreatic Ductal Adenocarcinoma
干预措施: SNV1521 (Drug)
Combination Dose Escalation
干预措施: SNV1521 (Drug)
Dose Expansion for Metastatic Castration Resistant Prostate Cancer
干预措施: SNV1521 (Drug)
Dose Expansion for Solid Tumors with Brain Metastases
干预措施: SNV1521 (Drug)
Combination 2 Dose Expansion for mCRPC or mCSPC
干预措施: Darolutamide (Drug)
结局指标
主要结局
Safety of SNV1521
时间窗: From first dose through last dose (up to 13 months)
Treatment emergent adverse events (TEAEs)
Tolerability of SNV1521
时间窗: DLTs: From first dose through completion of first cycle (28 days)
Incidence and frequency of dose-limiting toxicities (DLTs) (Dose-escalation arm only)
次要结局
未报告次要终点