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NCT Number: NCT06128148

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

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 .

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Key information

Conditions

Protein Kinase Inhibitors Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Other Protocol Specified Criteria Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

JYP0322 is an orally available inhibitor of ROS1 (coded by the gene ROS1). Molecular fusions are present in several different tumor types, including non-small cell lung cancer (NSCLC), glioma, etc. Patients with locally advanced or metastatic cancer with a detectable molecular fusion in targets of interest may be eligible for enrollment.

Phase 1 will assess safety and tolerability of JYP0322 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and efficacy will be assessed in the dose expansion portion of the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JYP0322 50 mg qd

Drug

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

Drug

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

Drug

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

Drug

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

Drug

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

Drug

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

Drug

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

Primary outcomes

  1. The frequency and severity of adverse events of JYP0322

    Time frame: 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.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: From the first dose of study drug until disease progression, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.

    ORR is the proportion of subjects with CR or PR , based on RECIST v1.1 criteria.

  2. Disease Control Rate (DCR)

    Time frame: From the first dose of study drug until disease progression, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.

    DCR is the proportion of subjects with CR or PR or SD, based on RECIST v1.1 criteria.

  3. Duration of Response (DOR)

    Time frame: From the date of first response until disease progression or death, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.

    The time from the first documented objective response to the first occurrence of tumor progression or death from any cause.

  4. Time to Response (TTR)

    Time frame: From the first dose of study drug to the date of first objective response, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.

    The time from treatment initiation to the first documented objective response.

  5. Progression-Free Survival (PFS)

    Time frame: From the first dose of study drug until disease progression or death, assessed by imaging every 8 weeks for the first 52 weeks, and every 12 weeks thereafter, up to 36 months.

    The time from initiation of JYP0322 treatment to tumor progression or death from any cause.

Sponsors and collaborators

Lead sponsor

Guangzhou JOYO Pharma Co., Ltd

Industry

Registry information

Official study title

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

Acronym: JYP0322

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Nov 13, 2023
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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