drugset / Trial / NCT06540963

Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

NCT06540963

Phase 2 Recruiting 98 enrolled Giselle Sholler
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the Food and Drug Administration (FDA) approved drug, naxitimab, 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). Naxitamab is FDA approved for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy, it may not be approved in the type of disease used in this study. The goals of this part of the study are: * Test the safety and tolerability of tipifarnib in combination with naxitimab 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

Timeline

Start
2024-12-06
Primary completion
2030-12-01
Completion
2035-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Naxitamab Monoclonal antibody Intravenous
Subject tipifarnib Small molecule Oral

Indications