Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors

Launched by GUANGZHOU JOYO PHARMA CO., LTD · Nov 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new oral medication called JYP0322 for patients with certain types of cancer that have a specific genetic feature known as ROS1 molecular fusion. The trial is aimed at understanding how safe the medication is, how well it works, and how the body processes it. This study is open to adults aged 18 and older who have locally advanced or metastatic solid tumors, meaning their cancer has spread beyond its original location. To qualify, patients need to have measurable cancer that has been confirmed by a doctor and should be expected to live at least three more months.

Participants in this trial will receive the medication and be monitored closely for any side effects and how effective the treatment is. It's important to note that individuals currently involved in another clinical trial or those with certain health conditions, like severe allergies or infections, may not be eligible to participate. This study is actively recruiting patients, and it offers a potential new treatment option for those with specific cancer types.

Gender

ALL

Eligibility criteria

• • 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