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

NCT06128148 · tracked via the Priya Life Science China tracker

Sponsor

Guangzhou JOYO Pharma Co., Ltd

Phase

Phase 1

Started

2022-05-04

Last updated

2025-07-14

Condition(s) studied

Protein Kinase InhibitorsOther Protocol Specified CriteriaLung NeoplasmsBrain Neoplasms

Investigational drug(s) / intervention(s)

JYP0322 50 mg qdJYP0322 100 mg qdJYP0322 200 mg qdJYP0322 100 mg bidJYP0322 150 mg bidJYP0322 200 mg bidJYP0322 150mg tid

JYP0322 50 mg qd: 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 qd: 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 qd: 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 bid: 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 bid: 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 bid: 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 tid: JYP0322 is administered orally at a dose of 150 mg tid for a specified duration until unacceptable toxicity, disease progression, or study completion.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

The frequency and severity of adverse events of JYP0322 — From the date of informed consent through 30 days after the last dose of study drug, approximately up to 36 months.
Evaluate the safety and tolerability of JYP0322 treatment. This will be assessed by: Incidence, nature, and severity of adverse events (AEs) during treatment, the proportion of patients requiring dose adjustment or permanent drug discontinuation.

Trial sites (1)

Facility	City	Region	Status
Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06128148 on ClinicalTrials.gov ↗ ← All trials in China