Study of Oral JYP0322 in Patients With Locally Advanced or Metastatic Cancer Targeting ROS1 Molecular Fusion.

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

Official Title
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A Phase 1 Study of Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JYP0322 in Patients With Locally Advanced/Metastatic Solid Tumors Harboring ROS1 Gene Fusion

Conditions
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Protein Kinase Inhibitors, Other Protocol Specified Criteria, Lung Neoplasms, Brain Neoplasms

Intervention / Treatment
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* Drug: JYP0322


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria Adult patients age 18 years or older. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors that have a ROS1 molecular fusion. Measurable disease according to RECIST version 1.1 Life expectancy of at least 3 months Other protocol specified criteria Key Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JYP0322<br>In adult patients with Ros-1 solid positive tumor progressed after standard of care. | Drug: JYP0322<br>* Orally administered<br>* Other names: experimental drug group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-Limiting Toxicity (DLT) | Determine dose-limiting toxicities of JYP0322 | At the end of Cycle 1 (each cycle is 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentrations of JYP0322 | Pharmacokinetic parameters of JYP0322 tablets for multiple oral administration. | At the end of Cycle 1 (each cycle is 28 days) | 
| Disease Control | Per RECIST v1.1 as assessed by Investigator. | Approx. 2 years | 
| Duration of Response | Per RECIST v1.1 as assessed by Investigator. | Approx. 2 years | 
| Progression-Free Survival (PFS) | Per RECIST v1.1 as assessed by Investigator. | Approx. 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ROS1 Fusions, ROS1 Gene Rearrangements, Primary brain tumors, ROS1