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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 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 .

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06128148
Study type Interventional
Source Guangzhou JOYO Pharma Co., Ltd
Contact
Status Recruiting
Phase Phase 1
Start date May 4, 2022
Completion date December 30, 2024
View Details
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