A Phase I/IIa, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Intraductal Administration of RXRG001 to Parotid Gland(s) in Adults With Radiation-Induced Xerostomia and Hyposalivation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 7
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
This is a first-in-human clinical study to evaluate the safety, tolerability and efficacy of RXRG001 administered in the ducts of the parotid glands in adult patients with radiation-induced xerostomia (dry mouth) and hyposalivation (reduced saliva production).
In Part 1 of the study (open-label, single-arm), patients will receive unilateral administrations of RXRG001 in 3 single ascending dose cohorts and in 3 multiple ascending dose cohorts.
Part 2 of the study has a randomized, double-blind, placebo-controlled design. Patients will receive bilateral administrations of RXRG001 in 3 multiple ascending dose cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Part 1 (Phase 1): single-arm open-label Part 2 (Phase2): randomized, double-blind, placebo-controlled, parallel-group
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
- •At least 18 years of age
- •Free from recurrence of your cancer and never have had another form of cancer for at least 2 years
- •Suffering from xerostomia and/or hyposalivation and have xerostomia symptoms which were not resolved after treatment for at least 3 months
- •Both parotid glands on imaging examination
排除标准
- •Any active infection
- •Heart failure, reduced kidney function or uncontrolled diabetes (Hemoglobin A1c >=8%)
- •History of autoimmune diseases known to potentially affect the salivary glands
- •Any malignancy, other than head and neck cancer within the past 3 years except for certain skin and cervical cancers
- •Active smoker or use tobacco products or have a history of substance or alcohol abuse
- •Other criteria apply
研究组 & 干预措施
Placebo Part 2
Randomized double-blind with 3 subsequent multiple dose cohorts. Placebo is administered intraductally in the salivary gland (bilateral)
干预措施: Placebo (Biological)
RXRG001 Part 1
Open-label, single arm with 6 subsequent dose cohorts (3 single dose and 3 multiple dose cohorts) of RXRG001 administered intraductally in the salivary gland (unilateral)
干预措施: RXRG001 (Biological)
RXRG001 Part 2
Randomized double-blind with 3 subsequent multiple dose cohorts. RXRG001 is administered intraductally in the salivary gland (bilateral)
干预措施: RXRG001 (Biological)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: Part 1: up to 36 weeks, Part 2: up to 36 weeks
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent serious adverse events
时间窗: Part 1: up to 36 weeks, Part 2: up to 36 weeks
Incidence of treatment-emergent serious adverse events
次要结局
未报告次要终点