NCT06541262

Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

Phase I/II Study of Silmitasertib (CX-4945) in Combination With Chemotherapy in Children and Young Adults With Relapsed Refractory Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the investigational drug, silmitasertib (a pill taken by mouth), in combination with FDA approved drugs for solid tumors. 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 silmitasertib in combination with chemotherapy * Test the safety and tolerability of silmitasertib in combination with chemotherapy in subjects 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

Conditions

• Neuroblastoma
• Ewing Sarcoma
• Osteosarcoma
• Rhabdomyosarcoma
• Liposarcoma

Interventions

Type	Name	Description
DRUG	Silmitasertib	Capsules
DRUG	Irinotecan	IV
DRUG	Temozolomide	Oral
DRUG	Vincristine	IV

Timeline

• Start date: 2024-10-30
• Primary completion: 2030-11-01
• Completion: 2035-11-01
• First posted: 2024-08-07
• Last updated: 2026-04-09

Locations

21 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study