NCT06128148 Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors
| NCT ID | NCT06128148 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Guangzhou JOYO Pharma Co., Ltd |
| Condition | Protein Kinase Inhibitors |
| Study Type | INTERVENTIONAL |
| Enrollment | 101 participants |
| Start Date | 2022-05-04 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 101 participants in total. It began in 2022-05-04 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Li Zhang, M.D.
PRINCIPAL INVESTIGATOR
Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT06128148 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Protein Kinase Inhibitors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06128148 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06128148 currently recruiting?
Yes, NCT06128148 is actively recruiting participants. Visit ClinicalTrials.gov or contact Guangzhou JOYO Pharma Co., Ltd to inquire about joining.
Where is the NCT06128148 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06128148 clinical trial?
NCT06128148 is sponsored by Guangzhou JOYO Pharma Co., Ltd. The principal investigator is Li Zhang, M.D. at Sun Yat-sen University. The trial plans to enroll 101 participants.