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Trial Title:
Study of Oral JYP0322 in Patients With Locally Advanced or Metastatic Cancer Targeting ROS1 Molecular Fusion.
NCT ID:
NCT06128148
Condition:
Protein Kinase Inhibitors
Other Protocol Specified Criteria
Lung Neoplasms
Brain Neoplasms
Conditions: Official terms:
Neoplasms
Lung Neoplasms
Brain Neoplasms
Conditions: Keywords:
ROS1 Fusions
ROS1 Gene Rearrangements
Primary brain tumors
ROS1
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JYP0322
Description:
Orally administered
Arm group label:
JYP0322
Other name:
experimental drug group
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 .
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Su Li
Phone:
+86 020-87343990
Email:
lisu@sysucc.org.cn
Start date:
May 4, 2022
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Guangzhou JOYO Pharma Co., Ltd
Agency class:
Industry
Source:
Guangzhou JOYO Pharma Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06128148
