RecruitingPhase 1NCT06128148

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

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

Sponsor

Guangzhou JOYO Pharma Co., Ltd

Enrollment

101 participants

Start Date

May 4, 2022

Study Type

INTERVENTIONAL

Conditions

Lung Neoplasms Brain Neoplasms Protein Kinase Inhibitors Other Protocol Specified Criteria

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase I safety and dose-finding study of a new drug called JYP0322 in patients with advanced solid tumors that have a specific genetic change called a ROS1 fusion — a mutation found in some lung cancers and other cancers. **You may be eligible if:** - You are 18 or older - Your cancer has been confirmed to have a ROS1 molecular fusion (a specific genetic alteration) - Your cancer is locally advanced or has spread and cannot be cured - You have at least one measurable tumor - Your life expectancy is at least 3 months **You may NOT be eligible if:** - You are currently enrolled in another therapeutic clinical trial - You have significant gut disease (like Crohn's disease, ulcerative colitis, or short bowel syndrome) that affects drug absorption - You have a history of severe allergic reactions to drugs - You have active bacterial, viral (including HIV), or other infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJYP0322 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.

DRUGJYP0322 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.

DRUGJYP0322 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.

DRUGJYP0322 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.

DRUGJYP0322 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.

DRUGJYP0322 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.

DRUGJYP0322 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.