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Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors

Study acronym: JYP0322
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 14, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv5
  2. Enrollment target: 54 to 101 Interventions: JYP0322 100 mg bid (Drug), JYP0322 100 mg qd (Drug), JYP0322 150 mg bid (Drug), JYP0322 200 mg bid (Drug), JYP0322 200 mg qd (Drug)… to JYP0322 100 mg bid (Drug), JYP0322 100 mg qd (Drug), JYP0322 150 mg bid (Drug), JYP0322 150mg tid (Drug), JYP0322 200 mg bid (Drug)… · Study arms: 6 to 7v4 Show 2 more changesShow less
    • Interventions: JYP0322 100 mg bid (Drug), JYP0322 100 mg qd (Drug), JYP0322 150 mg bid (Drug), JYP0322 200 mg bid (Drug), JYP0322 200 mg qd (Drug)… to JYP0322 100 mg bid (Drug), JYP0322 100 mg qd (Drug), JYP0322 150 mg bid (Drug), JYP0322 150mg tid (Drug), JYP0322 200 mg bid (Drug)…
    • Study arms: 6 to 7
  3. Primary endpoint revised Secondary endpoints: 4 to 5v3 Show 1 more changeShow less
    • Secondary endpoints: 4 to 5

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Jun 30, 2024 to Jun 30, 2026 Completion date: Dec 30, 2024 to Dec 30, 2027 · Interventions: JYP0322 (Drug) to JYP0322 100 mg bid (Drug), JYP0322 100 mg qd (Drug), JYP0322 150 mg bid (Drug), JYP0322 200 mg bid (Drug), JYP0322 200 mg qd (Drug)… · Study title shortened, about 6 words · 1 morev2 Show 4 more changesShow less
    • Completion date: Dec 30, 2024 to Dec 30, 2027
    • Interventions: JYP0322 (Drug) to JYP0322 100 mg bid (Drug), JYP0322 100 mg qd (Drug), JYP0322 150 mg bid (Drug), JYP0322 200 mg bid (Drug), JYP0322 200 mg qd (Drug)…
    • Study title shortened, about 6 words
    • Study arms: 1 to 6

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 .
Trial Details
NCT Number NCT06128148
Lead Sponsor Guangzhou JOYO Pharma Co., Ltd
Conditions Protein Kinase Inhibitors, Other Protocol Specified Criteria, Lung Neoplasms, Brain Neoplasms
Enrollment 101 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov