Spots Global Cancer Trial Database for Study of Oral JYP0322 in Patients With Locally Advanced or Metastatic Cancer Targeting ROS1 Molecular Fusion.

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Trial Identification

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

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

Study ID: NCT06128148

Conditions

Protein Kinase Inhibitors

Other Protocol Specified Criteria

Lung Neoplasms

Brain Neoplasms

Interventions

JYP0322

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 .

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.