A Phase 1/2 Study of Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Determine the incidence of dose limiting toxicities to evaluate safety and identify RP2D of PRGN-2012
研究概览
简要总结
This is a Phase 1/2 study in patients with a Recurrent Respiratory Papillomatosis (RRP) disease burden that requires repeated surgical procedures for management. RRP is a rare disease caused by the human papillomavirus (HPV). Participants with a pathologically confirmed diagnosis of papilloma and a clinical diagnosis of RRP will be screened for this protocol.
详细描述
This is a nonrandomized, Phase 1/2 safety and tolerability study. The safety and tolerability of PRGN-2012 will be assessed following two different dose levels during the Phase 1 dose escalation trial. In the Phase 2 portion of the study, treatment with PRGN-2012 at the recommended Phase 2 dose (RP2D) will be used to determine safety and efficacy of PRGN-2012.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Phase I; Dose Level 1
A standard dose escalation design was used to evaluate PRGN-2012 at a dose level of 1 × 10^11
干预措施: PRGN-2012 - Phase I; Dose Level 1 (Drug)
Phase I; Dose Level 2
A standard dose escalation design was used to evaluate PRGN-2012 at a dose level of 5 × 10^11
干预措施: PRGN-2012 - Phase I; Dose Level 2 (Drug)
Phase II; Dose Level 2
A dose of 5 x 10^11 PU was established as the RP2D, and the Phase 2 portion was implemented. The Phase 2 portion is designed as a dose expansion study, where patients were treated at the RP2D to evaluate the safety and efficacy of PRGN-2012.
干预措施: PRGN-2012 - Phase II; Dose Level 2 (Drug)
结局指标
主要结局
Determine the incidence of dose limiting toxicities to evaluate safety and identify RP2D of PRGN-2012
时间窗: 28 days
The incidence of dose limiting toxicities in Phase 1 will be reported per dose level. The dose level at which less than or equal to 1 out of 6 patients experience DLT will be identified as a RP2D.
Determine the percentage of subjects with a complete response following treatment with PRGN-2012
时间窗: 1 year
A complete response is defined as no requirement for surgical intervention in the 12 months after treatment
次要结局
- Number of surgery during the 12 months pre and 12 months post treatment(1 year)
- Overall Response Rate(1 year)
- Immune Responses(1 year)
- Rate of pulmonary RRP complete response in participants with pulmonary disease(1 year)
- Change in Vocal Function Scores over Time(1 year)
- Change in RRP Staging Assessment Scores Over Time(1 year)
- Time to recurrence of papillomatous disease after completion of treatment(1 year)
- Percentage of subjects with reduction in number of surgeries after completion of treatment(1 year)
- Safety of PRGN 2012 at RP2D(1 year)
- Rate of pulmonary RRP partial response in participants with pulmonary disease(1 year)