RecruitingPhase 1Phase 2NCT06541262

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


Sponsor

Milton S. Hershey Medical Center

Enrollment

104 participants

Start Date

Oct 30, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Max Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called silmitasertib (CX-4945) in combination with standard chemotherapy for children and young adults with solid tumors that have relapsed or stopped responding to treatment. The drug targets a specific protein (CK2) that helps cancer cells survive. The main cancer types studied include neuroblastoma, Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, and liposarcoma. **You may be eligible if...** - You were under 30 years old at initial diagnosis - You have a confirmed diagnosis of one of the eligible tumor types (neuroblastoma, Ewing sarcoma, or other specified solid tumors) - Your cancer has relapsed or is not responding to current treatment - Disease assessment has been performed after the last treatment dose **You may NOT be eligible if...** - Your cancer type is not among the eligible diagnoses - You have not recovered adequately from prior treatments - You have serious organ function problems preventing participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSilmitasertib

Capsules

DRUGIrinotecan

IV

DRUGTemozolomide

Oral

DRUGVincristine

IV


Locations(21)

University of Alabama/Children's of Alabama

Birmingham, Alabama, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

Rady Children's Hospital

San Diego, California, United States

University of Florida

Gainesville, Florida, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Arnold Palmer Hospital for Children

Orlando, Florida, United States

All Children's Hospital Johns Hopkins Medicine

St. Petersburg, Florida, United States

St. Joseph's Children's Hospital

Tampa, Florida, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine

Louisville, Kentucky, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Cardinal Glennon Children's Medical Center

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Penn State Milton S. Hershey Medical Center and Children's Hospital

Hershey, Pennsylvania, United States

Hasbro Children's Hospital

Providence, Rhode Island, United States

Monroe Carrell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Children's Medical Center

Dallas, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Virginia Commonwealth University

Richmond, Virginia, United States

UHC Sainte-Justine

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT06541262


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