Study of Oral JYP0322 in Patients With Locally Advanced or Metastatic Cancer Targeting ROS1 Molecular Fusion.

Sponsor

Guangzhou JOYO Pharma Co., Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06128148

Collaborator

(none)

Enrollment

Location

Arm

31.9

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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 .

Condition or Disease	Intervention/Treatment	Phase
Protein Kinase Inhibitors Other Protocol Specified Criteria Lung Neoplasms Brain Neoplasms	Drug: JYP0322	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Study of Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JYP0322 in Patients With Locally Advanced/Metastatic Solid Tumors Harboring ROS1 Gene Fusion

Actual Study Start Date :

May 4, 2022

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JYP0322 In adult patients with Ros-1 solid positive tumor progressed after standard of care.	Drug: JYP0322 Orally administered Other Names: experimental drug group

Arm

Intervention/Treatment

Experimental: JYP0322

In adult patients with Ros-1 solid positive tumor progressed after standard of care.

Drug: JYP0322

Orally administered

Other Names:

experimental drug group

Outcome Measures

Primary Outcome Measures

Dose-Limiting Toxicity (DLT) [At the end of Cycle 1 (each cycle is 28 days)]
Determine dose-limiting toxicities of JYP0322

Secondary Outcome Measures

Plasma Concentrations of JYP0322 [At the end of Cycle 1 (each cycle is 28 days)]
Pharmacokinetic parameters of JYP0322 tablets for multiple oral administration.
Disease Control [Approx. 2 years]
Per RECIST v1.1 as assessed by Investigator.
Duration of Response [Approx. 2 years]
Per RECIST v1.1 as assessed by Investigator.
Progression-Free Survival (PFS) [Approx. 2 years]
Per RECIST v1.1 as assessed by Investigator.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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