Testing JYP0322 for ROS1 Fusion-Positive Solid Tumors
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JYP0322 in Patients With Solid Tumors
Run by Guangzhou JOYO Pharma Co., Ltd · NCT06128148 · Data updated 2026-11-12
This study is testing a new oral medication called JYP0322 to see if it can help people with certain types of advanced solid tumors that have a specific genetic change called ROS1 fusion.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 101 (estimated) |
| Sponsor | Guangzhou JOYO Pharma Co., Ltd Industry-sponsored |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | May 4, 2022 |
| Main results expected | June 30, 2026 |
| Study ends | December 30, 2027 |
| Registry record updated | July 14, 2025 |
| Trial ID | NCT06128148 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with confirmed locally advanced or metastatic solid tumors that have a detectable ROS1 molecular fusion.
✕Probably not a fit
Patients currently participating in another therapeutic clinical trial or those with gastrointestinal diseases affecting drug absorption may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 1 trial evaluates the safety, tolerability, pharmacokinetics, and efficacy of JYP0322, an oral ROS1 inhibitor, in patients with locally advanced or metastatic solid tumors that harbor ROS1 molecular fusions. The study employs a multicenter, single-arm, dose-escalation design to determine the recommended dose for future phases. Patients with measurable disease will be enrolled, and the trial will assess both safety and efficacy during the dose expansion phase.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with ROS1 fusion-positive solid tumors.
How similar studies have gone: While this approach is novel for certain tumor types, similar studies targeting ROS1 fusions have shown promise in other contexts.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Li Zhang, M.D. — Sun Yat-sen University
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.