A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JYP0322 in Patients With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- The frequency and severity of adverse events of JYP0322
研究概览
简要总结
An open, non-randomized, multicenter, single-arm dose-escalation design, phase 1 trial to study the safety, tolerability, pharmacokinetics and efficacy of JYP0322 in patients with ROS1+ locally advanced/metastatic solid tumors .
详细描述
JYP0322 is an orally available inhibitor of ROS1 (coded by the gene ROS1). Molecular fusions are present in several different tumor types, including non-small cell lung cancer (NSCLC), glioma, etc. Patients with locally advanced or metastatic cancer with a detectable molecular fusion in targets of interest may be eligible for enrollment.
Phase 1 will assess safety and tolerability of JYP0322 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and efficacy will be assessed in the dose expansion portion of the study.
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
- 未提供
排除标准
- •Current participation in another therapeutic clinical trial.
- •Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.
- •A history of severe allergies, or a history of severe allergy, hypersensitivity or other hypersensitivity to any active or inactive ingredient of the study drug.
- •Known active infections (bacterial, viral including HIV positivity).
- •Other protocol specified criteria
研究组 & 干预措施
200 mg bid
Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 200 mg bid. This arm focuses on evaluating safety, tolerability, and pharmacokinetics (PK) at this dose.
干预措施: JYP0322 200 mg bid (Drug)
50 mg qd
Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 50 mg qd. This arm evaluates the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of this dose level.
干预措施: JYP0322 50 mg qd (Drug)
100 mg qd
Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 100 mg qd. This arm assesses safety, tolerability, and pharmacokinetics (PK) data for this dose level.
干预措施: JYP0322 100 mg qd (Drug)
200 mg qd
Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 200 mg qd. This arm examines the safety, pharmacokinetics (PK), and preliminary efficacy of this dose level.
干预措施: JYP0322 200 mg qd (Drug)
100 mg bid
Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 100 mg bid. The arm evaluates the safety, tolerability, and pharmacokinetics (PK) of this increased dosing frequency.
干预措施: JYP0322 100 mg bid (Drug)
150 mg bid
Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 150 mg bid. This arm aims to determine the optimal dosing for safety, pharmacokinetics (PK), and efficacy.
干预措施: JYP0322 150 mg bid (Drug)
150 mg tid
Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 150 mg tid. This arm focuses on evaluating safety, tolerability, and pharmacokinetics (PK) at this dose.
干预措施: JYP0322 150mg tid (Drug)
结局指标
主要结局
The frequency and severity of adverse events of JYP0322
时间窗: From the date of informed consent through 30 days after the last dose of study drug, approximately up to 36 months.
Evaluate the safety and tolerability of JYP0322 treatment. This will be assessed by: Incidence, nature, and severity of adverse events (AEs) during treatment, the proportion of patients requiring dose adjustment or permanent drug discontinuation.
次要结局
- Objective Response Rate (ORR)(From the first dose of study drug until disease progression, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.)
- Disease Control Rate (DCR)(From the first dose of study drug until disease progression, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.)
- Duration of Response (DOR)(From the date of first response until disease progression or death, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.)
- Time to Response (TTR)(From the first dose of study drug to the date of first objective response, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.)
- Progression-Free Survival (PFS)(From the first dose of study drug until disease progression or death, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.)