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

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

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 .

Study Overview

• Status: Recruiting
• Conditions: Lung Neoplasms; Brain Neoplasms; Protein Kinase Inhibitors; Other Protocol Specified Criteria
• Intervention / Treatment: Drug: JYP0322

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 Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Su Li; Phone Number: +86 020-87343990; Email: lisu@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-Limiting Toxicity (DLT)	Determine dose-limiting toxicities of JYP0322	At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guangzhou JOYO Pharma Co., Ltd
• Investigators: Principal Investigator: Li Zhang, M.D., Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: November 4, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Estimated): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: ROS1; Primary brain tumors; ROS1 Fusions; ROS1 Gene Rearrangements
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms; Lung Neoplasms; Brain Neoplasms
• Other Study ID Numbers: JYP0322-M101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No