CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 101 target
Drug / intervention
JYP0322 50 mg qd +6 moredrug
Likely dose
JYP0322 50 mg qdfrom record
Key inclusion· 4
  • Age 18 years or older
  • Histologically or cytologically confirmed ROS1 molecular fusion in locally advanced or metastatic solid tumors
  • Measurable disease by RECIST version 1.1
  • Life expectancy of at least 3 months
Key exclusion· 4
  • Current participation in another therapeutic clinical trial
  • Gastrointestinal disease or malabsorption syndromes affecting drug absorption
  • History of severe allergies or hypersensitivity to study drug components
  • Known active infections including bacterial, viral, and HIV

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06128148
NCT06128148Phase 1RecruitingOn TrackUpdated 11mo ago
Long Recruiting

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JYP0322 in Patients With Solid Tumors

Guangzhou JOYO Pharma Co., Ltd·interventional·Posted Nov 13, 2023·Updated Jul 14, 2025

In Brief

A Phase 1 clinical trial evaluating JYP0322 50 mg qd, JYP0322 100 mg qd, and 5 other interventions for Protein Kinase Inhibitors and 3 related conditions. Currently recruiting, targeting 101 participants across 1 site.

Detailed 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 .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 1Recruiting
202320242025202620272028
First PostedNov 13, 2023
Enrollment StartMay 4, 2022
Primary CompletionJun 30, 2026
Study CompletionDec 30, 2027
TodayJul 1, 2026
Enrollment to primary: 4.2 yearsPosted 2.6 years ago

Interventions

JYP0322 50 mg qddrug

JYP0322 is administered orally at a dose of 50 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.

JYP0322 100 mg qddrug

JYP0322 is administered orally at a dose of 100 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.

JYP0322 200 mg qddrug

JYP0322 is administered orally at a dose of 200 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.

JYP0322 100 mg biddrug

JYP0322 is administered orally at a dose of 100 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.

JYP0322 150 mg biddrug

JYP0322 is administered orally at a dose of 150 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.

JYP0322 200 mg biddrug

JYP0322 is administered orally at a dose of 200 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.

JYP0322 150mg tiddrug

JYP0322 is administered orally at a dose of 150 mg tid for a specified duration until unacceptable toxicity, disease progression, or study completion.