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

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 advanced/metastatic solid tumors .

Eligibility

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

Conditions6

Browse More Trials