Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors
Recruiting · NCT06128148 · Interventional (participants receive a specific treatment) · Lead sponsor: Guangzhou JOYO Pharma Co., Ltd
View the official record on ClinicalTrials.gov →Interventions studied
JYP0322 100 mg bidJYP0322 100 mg qdJYP0322 150 mg bidJYP0322 150mg tidJYP0322 200 mg bidJYP0322 200 mg qdJYP0322 50 mg qd
What this trial is about
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 .
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Sun Yat-Sen University Cancer Center - Guangzhou, Guangdong, China