A Phase 1, Open-Label, Dose-Escalation and Expansion Study of SNV1521 in Combination With RAS Inhibition in Participants With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Safety and tolerability of SNV1521 plus daraxonrasib: treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities
研究概览
简要总结
This study is a Phase 1 clinical trial testing an oral investigational drug called SNV1521 together with a RAS-targeted cancer medicine in people with pancreatic cancer that cannot be removed by surgery or has spread. The main goals are to find doses of the drug combination that are safe and tolerable and to look for early signs that the treatment may help control the cancer. Participants will receive the study medicines in repeating cycles and will have regular blood tests, scans, and other exams to monitor side effects and how their cancer responds.
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
- •Adults (18 years and older).
- •Diagnosis of pancreatic cancer that cannot be removed by surgery or has spread to other parts of the body.
- •Cancer confirmed by tissue or cell examination (histology or cytology).
- •At least one measurable tumor on scans.
- •Good enough general health and organ function to receive study treatment, as judged by the study doctor.
- •Able to swallow oral medicines.
- •Willing to follow study visit schedule and contraception requirements.
排除标准
- •Serious heart, lung, liver, or other medical problems that would make study treatment unsafe.
- •Active, uncontrolled infections.
- •Other active cancers that could interfere with study assessments (except certain early-stage cancers that have been treated).
- •Prior treatments or medicines that are not allowed by the protocol (for example, some strong drug interactions).
- •Known brain or nervous system involvement from the cancer that is not stable or controlled.
- •Pregnant or breastfeeding, or unwilling to use required birth control during and after the study.
研究组 & 干预措施
Escalation
Participants in this arm will take SNV1521 by mouth together with a RAS-targeted cancer medicine. The dose of SNV1521 will be increased in small steps to find a safe and tolerable dose of the combination in people with advanced pancreatic cancer.
干预措施: daraxonrasib (Drug)
Escalation
Participants in this arm will take SNV1521 by mouth together with a RAS-targeted cancer medicine. The dose of SNV1521 will be increased in small steps to find a safe and tolerable dose of the combination in people with advanced pancreatic cancer.
干预措施: SNV1521 (Drug)
结局指标
主要结局
Safety and tolerability of SNV1521 plus daraxonrasib: treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities
时间窗: through study completion, an average of 1 year
Number, type, and severity of treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities in participants receiving SNV1521 plus daraxonrasib, used to identify doses suitable for further study, classified and graded according to CTCAE v6.0 and protocol-defined DLT criteria
次要结局
- Maximum plasma concentration (Cmax) of SNV1521(through study completion, an average of 1 year)
- Area under the plasma concentration-time curve (AUC) of SNV1521(through study completion, an average of 1 year)
- Maximum plasma concentration (Cmax) of daraxonrasib(through study completion, an average of 1 year)
- Area under the plasma concentration-time curve (AUC) of daraxonrasib(through study completion, an average of 1 year)