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Recruiting NCT06128148

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

Phase I Interventional Protein Kinase Inhibitors Other Protocol Specified Criteria Lung Neoplasms Brain Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JYP0322 50 mg qd, JYP0322 100 mg qd, JYP0322 200 mg qd, JYP0322 100 mg bid.
Who it may be relevant to
Registry conditions: Protein Kinase Inhibitors, Other Protocol Specified Criteria, Lung Neoplasms, Brain Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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 .

Detailed description

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.

Interventions

  • Drug 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.
  • Drug 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.
  • Drug 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.
  • Drug 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.
  • Drug 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.
  • Drug 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.
  • Drug 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.

Primary outcome measures

  • 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.]
Secondary outcome measures (5)
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-Sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT06128148 · JYP0322M101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗