NCT07354711招募中1 期
A Phase I/II Study of 3H-10000 (an Anti-FGFR2b Antibody-Drug Conjugate) in Subjects With Unresectable or Metastatic Advanced Solid Tumors
3H Pharmaceuticals Co., Ltd.0 个研究点目标入组 170 人开始时间: 2026年1月4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
- 170
研究概览
简要总结
The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3H-10000 in the treatment of unresectable or metastatic solid tumors .
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
- •Subjects must be willing and able to sign the ICF and to adhere to the study visit schedule and other protocol requirements.
- •Male or female subjects aged ≥18 years at the time of signing the ICF.
- •According to RECIST v1.1, there is at least one measurable lesion.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 point.
- •Life expectancy of ≥3 months.
排除标准
- •Meningeal diseases or carcinomatous meningitis.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage every two weeks or more frequently.
- •Having received treatment with other investigational drugs within 4 weeks prior to the first dose of the study drug.
- •Any AEs induced by prior anti-tumor therapy having not resolved to Grade 1 or lower (except for alopecia or any other Grade 2 AEs assessed by the investigator as not being associated with any safety risk).
- •Any corneal or retinal disease/keratopathy assessed by the investigator as of clinical significance, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis.
研究者
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