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Clinical Trials associated with JYP-0322 / Not yet recruitingPhase 3 A Randomized, Open-Label, Multicenter, Phase 3 Study Evaluating the Efficacy and Safety of JYP0322 Versus Platinum-Based Chemotherapy in ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients Previously Treated With ROS1-TKI Therapy.
The primary purpose of the study was to compare progression-free survival of JYP0322 vs. platinum-based doublet chemotherapy in patients previously treated with ROS1-TKIs. Patients in the chemotherapy arm are given the option to switch to JYP0322 after BICR confirmed progressive disease (PD), while also have the choice to pursue with other drugs after discussing with their physicians.
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JYP0322 in Patients With Solid Tumors
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 .
/ Not yet recruitingPhase 1 [14C]JYP0322在健康参与者体内的物质平衡临床试验
[Translation] Clinical trial of [14C]JYP0322 in healthy participants to assess substance balance.
主要研究目的
1) 定量分析男性健康参与者单次口服[14C]JYP0322后,尿液和粪便中的总放射性,获得人体放射性排泄率数据和主要排泄途径;
2) 获得男性健康参与者单次口服[14C]JYP0322后,血浆、尿液、粪便中的放射性代谢物谱,鉴定主要代谢产物,确定JYP0322在人体内的主要代谢途径及消除途径;
3) 定量分析男性健康参与者单次口服[14C]JYP0322后血浆中的总放射性,获得血浆总放射性的药代动力学参数;
次要研究目的
1) 采用已验证的LC-MS/MS方法定量分析血浆中JYP0322及其代谢产物(如适用)的浓度,获得血浆中JYP0322及其代谢产物(如适用)的药代动力学参数;
2) 考察全血和血浆中总放射性的分配情况以及全血(如适用)中总放射性的药代动力学;
3) 评价[14C]JYP0322单次给药后男性健康参与者的安全性。
[Translation] Primary Research Objectives:
1) To quantitatively analyze the total radioactivity in urine and feces of healthy male participants after a single oral administration of [14C]JYP0322, obtaining data on the human body's radioactive excretion rate and main excretion pathways;
2) To obtain the radiometabolite profiles in plasma, urine, and feces of healthy male participants after a single oral administration of [14C]JYP0322, identifying the main metabolites and determining the main metabolic and elimination pathways of JYP0322 in the human body;
3) To quantitatively analyze the total radioactivity in plasma of healthy male participants after a single oral administration of [14C]JYP0322, obtaining the pharmacokinetic parameters of total plasma radioactivity;
Secondary Research Objectives:
1) To quantitatively analyze the concentration of JYP0322 and its metabolites (if applicable) in plasma using a validated LC-MS/MS method, obtaining the pharmacokinetic parameters of JYP0322 and its metabolites (if applicable) in plasma;
2) 3) Evaluate the safety of a single dose of [14C]JYP0322 in healthy male participants.
100 Clinical Results associated with JYP-0322
100 Translational Medicine associated with JYP-0322
100 Patents (Medical) associated with JYP-0322
100 Deals associated with JYP-0322