Actively Recruiting
Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JYP0322 in Patients With ROS1 Fusion-Positive Solid Tumors
Led by Guangzhou JOYO Pharma Co., Ltd · Updated on 2025-07-14
101
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying JYP0322, an oral drug that inhibits the ROS1 gene fusion, in patients with locally advanced or metastatic solid tumors that test positive for ROS1 fusion. This phase 1 trial aims to evaluate the safety, tolerability, how the drug moves through the body, and early signs of effectiveness. The study focuses on patients with measurable disease and a life expectancy of at least 3 months. Participants will receive JYP0322 at different dose levels ranging from 50 mg once daily to 150 mg three times daily. The trial uses a non-randomized, single-arm, dose-escalation design to find the best dose for future studies. Treatment continues until unacceptable side effects, disease progression, or study completion. The study includes multiple arms, each testing a specific dose and frequency to assess safety and drug behavior. During the study, participants will be closely monitored for adverse events from consent through 30 days after the last dose, up to about 36 months. Imaging scans will assess tumor response every 8 weeks during the first year and every 12 weeks thereafter. Researchers will measure outcomes such as response rate, disease control, duration and time to response, and progression-free survival. This careful follow-up helps understand the treatment's effects and safety over time.
CONDITIONS
Brief Title
Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients age 18 years or older
- Diagnosis of locally advanced or metastatic solid tumors with a ROS1 molecular fusion confirmed by histology or cytology
- Measurable disease according to RECIST version 1.1
- Life expectancy of at least 3 months
- Fulfillment of other protocol specified criteria
You will not qualify if you...
- Current participation in another therapeutic clinical trial
- Presence of gastrointestinal diseases such as Crohn's disease, ulcerative colitis, or short gut syndrome, or other malabsorption syndromes affecting drug absorption
- History of severe allergies or hypersensitivity to any ingredient of the study drug
- Known active infections including bacterial, viral infections, or HIV positivity
- Presence of other protocol specified exclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 36 months or until unacceptable toxicity or disease progression
Participants receive oral doses of JYP0322 at varying dose levels until unacceptable toxicity, disease progression, or study completion. Safety, tolerability, pharmacokinetics, and preliminary efficacy are assessed during this period.
Imaging visits every 8 weeks for the first 52 weeks, then every 12 weeks thereafter; additional visits for treatment administration and safety assessments as scheduled
Duration - 30 days after the last dose
Participants are monitored for safety and adverse events for 30 days after the last dose of the study drug.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here