Status:
RECRUITING
Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors
Lead Sponsor:
Guangzhou JOYO Pharma Co., Ltd
Conditions:
Protein Kinase Inhibitors
Other Protocol Specified Criteria
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 advanc...
Detailed Description
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. Pa...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT06128148
Start Date
May 4 2022
End Date
December 30 2027
Last Update
July 14 2025
Active Locations (1)
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1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060