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

Lung Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128148
• Other study ID #: JYP0322-M101
• Status: Recruiting
• Phase: Phase 1
• Start date: May 4, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: Guangzhou JOYO Pharma Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Lung Neoplasms
• Neoplasms
• Protein Kinase Inhibitors

Intervention

Drug:
• JYP0322
Orally administered

Locations

Country	Name	City	State
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou JOYO Pharma Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-Limiting Toxicity (DLT)	Determine dose-limiting toxicities of JYP0322	At the end of Cycle 1 (each cycle is 28 days)
Secondary	Plasma Concentrations of JYP0322	Pharmacokinetic parameters of JYP0322 tablets for multiple oral administration.	At the end of Cycle 1 (each cycle is 28 days)
Secondary	Disease Control	Per RECIST v1.1 as assessed by Investigator.	Approx. 2 years
Secondary	Duration of Response	Per RECIST v1.1 as assessed by Investigator.	Approx. 2 years
Secondary	Progression-Free Survival (PFS)	Per RECIST v1.1 as assessed by Investigator.	Approx. 2 years