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

July 9, 2025 updated by: Guangzhou JOYO Pharma Co., Ltd

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

101

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 50 mg qd
Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 50 mg qd. This arm evaluates the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of this dose level.
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.
Experimental: 100 mg qd
Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 100 mg qd. This arm assesses safety, tolerability, and pharmacokinetics (PK) data for this dose level.
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.
Experimental: 200 mg qd
Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 200 mg qd. This arm examines the safety, pharmacokinetics (PK), and preliminary efficacy of this dose level.
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.
Experimental: 100 mg bid
Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 100 mg bid. The arm evaluates the safety, tolerability, and pharmacokinetics (PK) of this increased dosing frequency.
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.
Experimental: 150 mg bid
Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 150 mg bid. This arm aims to determine the optimal dosing for safety, pharmacokinetics (PK), and efficacy.
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.
Experimental: 200 mg bid
Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 200 mg bid. This arm focuses on evaluating safety, tolerability, and pharmacokinetics (PK) at this dose.
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.
Experimental: 150 mg tid
Participants with ROS1 fusion-positive locally advanced or metastatic solid tumors will receive JYP0322 at a dose of 150 mg tid. This arm focuses on evaluating safety, tolerability, and pharmacokinetics (PK) at this dose.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of informed consent through 30 days after the last dose of study drug, approximately up to 36 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
DCR is the proportion of subjects with CR or PR or SD, based on RECIST v1.1 criteria.
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.
The time from the first documented objective response to the first occurrence of tumor progression or death from any cause.
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.
The time from treatment initiation to the first documented objective response.
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.
The time from initiation of JYP0322 treatment to tumor progression or death from any cause.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou JOYO Pharma Co., Ltd

Investigators

  • Principal Investigator: Li Zhang, M.D., Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

November 4, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JYP0322M101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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