Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangzhou JOYO Pharma Co., Ltd
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- JYP0322 50 mg qd
- JYP0322 100 mg qd
- JYP0322 200 mg qd
- JYP0322 100 mg bid
- JYP0322 150 mg bid
- JYP0322 200 mg bid
- JYP0322 150mg tid
Treatment groups
101 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Locations
1Sun Yat-Sen University Cancer Center510060, GuangzhouGuangdong, China
Sponsors and collaborators
Guangzhou JOYO Pharma Co., Ltd
Lead sponsor
Source ClinicalTrials.gov