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

Inclusion Criteria5

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 Criteria5

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

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.