NCT07605962招募中1 期
A Phase I/II Open-Label, Dose Escalation, Dose Optimization, and Cohort Expansion Trial to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of UI-102, a Novel Cholesteryl Pullulan (CHP) Nanoparticle-formulated TLR7/8 Agonist in Patients With Selected Locally Advanced and/or Metastatic Solid Tumors
United Immunity, co., Ltd.3 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2026年5月20日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 3
研究概览
简要总结
This phase 1/2 first-in-human study is designed to assess the safety and efficacy of UI-102, a TLR7/8 agonist encapsulated in a Cholesteryl Pullulan Nanoparticle.
详细描述
This phase 1/2 , open-labelled, multi-center study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, and preliminary clinical activities of UI-102 in patients with advanced solid tumors. Phase 2 part is designed to assess the efficacy and safety as well as to optimize the dosing amount of UI-102
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
盲法说明
Open Label Multi Center Non Randomized Study
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
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1,
- •18 Years and Older (adult, older adult),
- •Histologically confirmed advanced cancer,
- •Archived or fresh tumor tissue sample that must be confirmed as adequate,
- •Evaluable/Measurable disease per RECIST 1.1,
- •Previously received applicable standard treatments,
- •Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control
排除标准
- •central nervous system metastasis,
- •Ongoing or uncontrolled ascites or pleural effusion,
- •Significant ongoing toxicity from prior anticancer treatment,
- •Out-of-range laboratory values,
- •Clinically significant lung, heart, or autoimmune disease,
- •Ongoing requirement for immunosuppressive treatment,
- •Significant secondary malignancy,
- •Hypersensitivity to study drug or excipients,
- •Pregnant or lactating,
- •Ongoing active infection
研究者
研究点 (3)
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