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NCT ID: NCT06465199 Not yet recruiting - Ewing Sarcoma Clinical Trials

Difluoromethylornithine (DFMO) and AMXT-1501 for Neuroblastoma, CNS Tumors, and Sarcomas

Start date: July 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the investigational drug AMXT 1501 (a pill taken by mouth) in combination with the drug difluoromethylornithine (DFMO) for infusion administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). An investigational drug is one that has not been approved by the U.S. Food & Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat. The goals of this part of the study are: - Establish a recommended dose of AMXT 1501 in combination with DFMO for infusion - Test the safety and tolerability of AMXT 1501 in combination with DFMO for infusion in patients with cancer - To determine the activity of study treatments chosen based on: - How each subject responds to the study treatment - How long a subject lives without their disease returning/progressing