Bicycle Continued Access Protocol (BiCAP) for Participants Receiving a Bicycle Investigational Product on a BicycleTx Limited-Sponsored Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 16
- 主要终点
- Monitor safety for participants receiving a Bicycle investigational product
研究概览
简要总结
BiCAP-201 trial offers continued access to Bicycle investigational product treatments zelenectide pevedotin, nuzefatide pevedotin, and BT7480 for participants currently receiving and deriving clinical benefit from one of these treatments in a Bicycle Therapeutics-sponsored clinical trial. Bicycle Therapeutics will continue to monitor longer term safety of these treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Participants must be receiving a Bicycle investigational product in another Bicycle-sponsored clinical study and will benefit from continued study treatment as assessed by the Investigator. The participant must be tolerating the treatment and the disease being treated has not grown on the treatment and have not met a treatment discontinuation criterion on the parent study.
- •Participants must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
- •Pregnancy must be avoided while on treatment and for up to 6.5 months following end of study treatment.
- •Participants must have completed testing requirements of the Bicycle-sponsored parent study.
排除标准
- •Participant is receiving pembrolizumab or nivolumab only, and has been treated for >24 months from start of therapy on the parent study.
- •Participant is receiving Bicycle investigational product post-disease progression.
- •Participant has a new medical condition requiring treatment with strong cytochrome P450 3A (CYP3A) inhibitor or inducer while receiving zelenectide pevedotin or nuzefatide pevedotin.
研究组 & 干预措施
BT7480
干预措施: BT7480 (Drug)
Zelenectide pevedotin
干预措施: Zelenectide pevedotin (Drug)
结局指标
主要结局
Monitor safety for participants receiving a Bicycle investigational product
时间窗: Up to 48 months
Incidence, severity, seriousness, relationship, and type of serious adverse events (SAEs), treatment-related adverse events (TRAEs), adverse events of clinical interest (AECIs), and treatment modifications as a result of any of these
次要结局
未报告次要终点