NCT07601386尚未招募1 期
A Phase Ib Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of JMKX000189 Tablets in Patients With Chemotherapy-Induced Peripheral Neuropathy
Shanghai Jeyou Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年5月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 试验地点
- 1
研究概览
简要总结
This Phase Ib clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of JMKX000189 tablets in participants with chemotherapy-induced peripheral neuropathy (CIPN).
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75 years (inclusive), male or female.
- •Eastern Cooperative Oncology Group (ECOG) performance status score ≤
- •Life expectancy of ≥ 3 months.
- •Histologically or cytologically confirmed malignant solid tumors.
- •Investigator-confirmed diagnosis of CIPN accompanied with chemotherapy.
- •Adequate organ function.
排除标准
- •Presence of any type of peripheral neuropathy other than CIPN (e.g., diabetic, paraneoplastic, or nutritional).
- •Toxicities from prior anti-tumor therapy (excluding CIPN) > CTCAE Grade 1 within 2 weeks of first dose (excluding alopecia, skin pigmentation, stable hypothyroidism, or chronic events).
- •Participants with any of the following cardiovascular diseases or medical history:
- •Ischemic heart disease or myocardial infarction, unstable angina, coronary artery spasm, congestive heart failure (NYHA Class III-IV), cardiac arrest, stroke, or transient ischemic attack within 6 months;
- •Other clinically significant cardiac disorders per investigator's judgment.
- •Presence of active systemic infections.
- •History of or active primary/secondary immunodeficiency.
- •Participation in an interventional clinical trial within 1 month prior to screening.
- •Hypersensitivity to any component of the study drug (and its excipients).
- •Any condition deemed by the investigator to pose excessive risk, confound results, or interfere with compliance.
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer.Small Cell Lung CancerNCT07559929Hangzhou DAC Biotechnology Co., Ltd.200
招募中
1 期
Study of EPI-001 in Patients With Androgenetic AlopeciaAndrogenetic AlopeciaNCT07618195Epibiotech42
尚未招募
1 期
Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 in Combination With Ivonescimab in Sq-NSCLC PatientsNCT07614646Everest Medicines (Beijing) Co., Ltd.13
尚未招募
1 期
Lisatoclax Plus R-CHOP or Pola-R-CHP in Untreated DLBCL: A Phase Ib/II StudyNCT07398638Sun Yat-sen University122
招募中
1 期
A Study of Rocbrutinib Combined With R-GemOx in Patients With Relapsed or Refractory Diffuse Large B-cell LymphomaDLBCLNCT07570017Guangzhou Lupeng Pharmaceutical Company LTD.42