Clinical trial · Interventional
Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JYP0322 in Patients With Solid Tumors
NCT06128148CI-TRIAL-00092085JYP0322recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 .
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Other Protocol Specified Criteria | — | UNRESOLVED | — |
| Protein Kinase Inhibitors | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JYP0322 100 mg bid | Drug | — | UNRESOLVED |
| JYP0322 100 mg qd | Drug | — | UNRESOLVED |
| JYP0322 150 mg bid | Drug | — | UNRESOLVED |
| JYP0322 150mg tid | Drug | — | UNRESOLVED |
| JYP0322 200 mg bid | Drug | — | UNRESOLVED |
| JYP0322 200 mg qd | Drug | — | UNRESOLVED |
| JYP0322 50 mg qd | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- 50 mg qd
- description
- Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 50 mg qd. This arm evaluates the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of this dose level.
- interventionNames
- Drug: JYP0322 50 mg qd
- type
- EXPERIMENTAL
- label
- 100 mg qd
- description
- Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 100 mg qd. This arm assesses safety, tolerability, and pharmacokinetics (PK) data for this dose level.
- interventionNames
- Drug: JYP0322 100 mg qd
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.