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

ClinicalTrials.gov ID: NCT06541262

Public ClinicalTrials.gov record NCT06541262. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 9:05 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT06541262
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Milton S. Hershey Medical Center; Other
Enrollment: 104 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: Up to 30 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 29, 2024
Primary completion: Oct 31, 2030
Completion: Oct 31, 2035
Last update posted: Sep 2, 2026

2024 – 2035

United States locations

U.S. sites: 22
U.S. states: 16
U.S. cities: 22

Facility	City	State	ZIP	Site status
University of Alabama/Children's of Alabama	Birmingham	Alabama	35233	Recruiting
Phoenix Children's Hospital	Phoenix	Arizona	85016	Recruiting
UCSF Benioff Children's Hospital Oakland	Oakland	California	94609	Recruiting
Rady Children's Hospital	San Diego	California	92123	Recruiting
Connecticut Children's Hospital	Hartford	Connecticut	06106	Recruiting
University of Florida	Gainesville	Florida	32611	Recruiting
Nicklaus Children's Hospital	Miami	Florida	33155	Recruiting
Arnold Palmer Hospital for Children	Orlando	Florida	32806	Recruiting
All Children's Hospital Johns Hopkins Medicine	St. Petersburg	Florida	33701	Recruiting
St. Joseph's Children's Hospital	Tampa	Florida	33614	Recruiting
Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	96813	Recruiting
Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine	Louisville	Kentucky	40202	Recruiting
Children's Hospital of Michigan/Wayne State University	Detroit	Michigan	48201	Recruiting
Children's Mercy Hospitals and Clinics	Kansas City	Missouri	64108	Recruiting
Cardinal Glennon Children's Medical Center	St Louis	Missouri	63104	Recruiting
Hackensack University Medical Center	Hackensack	New Jersey	07601	Recruiting
Penn State Milton S. Hershey Medical Center and Children's Hospital	Hershey	Pennsylvania	17033	Recruiting
Hasbro Children's Hospital	Providence	Rhode Island	02903	Recruiting
Monroe Carrell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee	37232	Recruiting
Children's Medical Center	Dallas	Texas	75235	Recruiting
Primary Children's Hospital	Salt Lake City	Utah	84113	Recruiting
Virginia Commonwealth University	Richmond	Virginia	23284	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06541262, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 2, 2026 · Synced Sep 6, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06541262 live on ClinicalTrials.gov.

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