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

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

Study Purpose

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 .

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06128148
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Guangzhou JOYO Pharma Co., Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Li Zhang, M.D.
Principal Investigator Affiliation	Sun Yat-sen University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Protein Kinase Inhibitors, Other Protocol Specified Criteria, Lung Neoplasms, Brain Neoplasms

Additional Details

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.

Arms & Interventions

Arms

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.

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.

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.

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.

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.

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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.