drugset / Trial / NCT06465199

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

NCT06465199

RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to evaluate the investigational oral drug AMXT 1501 in combination with oral eflornithine (DFMO). 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 * Test the safety and tolerability of AMXT 1501 in combination with DFMO * 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

Timeline

Start
2026-05-13
Primary completion
2033-05
Completion
2035-05

Drugs

EvaluationDrugModalityDoseRoute
Subject AMXT 1501 Small molecule 350 mg/m2 Oral
Subject Eflornithine Small molecule Oral