NCT07747935尚未招募1 期
A Phase 1b, Open-Label, Investigator-Led Study of Neoadjuvant RBP-01 In Patients With Primary Uveal Melanoma
ReBio Pharma0 个研究点目标入组 30 人开始时间: 2026年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Safety events
研究概览
简要总结
Neoadjuvant RBP-01 in patients with primary uveal melanoma.
详细描述
Phase 1b open-label study to evaluate the safety, tolerability, and preliminary efficacy of the localized Protein Kinase C (PKC) inhibitor RBP-01 in patients with primary uveal melanoma (UM) requiring either enucleation or plaque brachytherapy. Patients will receive neoadjuvant treatment for up to 6 months, followed by definitive local therapy.
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
- •Male and female participants aged ≥18 years.
- •Participants with choroidal and ciliary body [P13.1] tumours.
- •Participants with primary localized UM requiring enucleation (Cohort 1) or plaque brachytherapy at high risk of vision loss (Cohort 2), as per investigator assessment.
- •Participants with ECOG performance status 0-
- •Tumour thickness > 4 mm.
- •Females of child bearing potential must have a negative urine pregnancy test result at screening.
排除标准
- •Participant has received previous treatment with a PKC inhibitor at any time.
- •Participant has received a prior diagnosis of metastatic disease.
- •Presence of a tumour originating from the iris.
- •Presence of intractable untreatable raised intraocular pressure.
- •Presence of ring melanoma.
- •Presence of severe glaucoma or uveitis.
- •Participant is under active treatment for any other macular condition.
- •9. Female participants who are pregnant or lactating.
- •Participant is unable to follow protocol requirements.
研究组 & 干预措施
RBP-01
Experimental
All participants receive RBP-01 using the same dosing regimen
干预措施: RBP-01 (Drug)
结局指标
主要结局
Safety events
时间窗: From first dose until 6 months
• The incidence of AEs, TEAEs, SAEs and proportion of participants discontinuing from the study
次要结局
- preliminary effectiveness(Up to 6 months)
- Eye salvage rate(Up to 6 months)
研究者
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