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Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT06541262•Milton S. Hershey Medical Center

View on ClinicalTrials.gov

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

Age

0 - 30 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age: Less than 30 years old at initial diagnosis
•2. Pathology All subjects must have a confirmed diagnosis of tumor type. Phase I: Relapsed/refractory solid tumors: Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Liposarcoma
•Phase II:
•* Relapsed/refractory Neuroblastoma
•* Relapsed/refractory Ewing sarcoma
•3. Tumor assessment:
•Disease assessment is required for eligibility and must be done after last dose of previous therapy and prior to first dose of study drug.
•4. Disease Status:
•Relapsed/Refractory Neuroblastoma Relapsed disease defined as neuroblastoma that was previously in remission after standard therapy (at least 4 cycles of aggressive multi-drug induction chemotherapy, with or without radiation and surgery, followed by immunotherapy, or according to a standard high-risk treatment/neuroblastoma protocol) and has now relapsed and is in any number of relapses.
•Refractory disease defined as High-risk neuroblastoma (as defined by INRG) that failed to achieve CR after at least 4 cycles of aggressive multi-drug induction chemotherapy, progression during upfront therapy or with disease remaining after standard immunotherapy.
+29 more criteria

Exclusion Criteria

•1. Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
•3. Subjects who are currently receiving Vitamin K antagonists (warfarin).
•4. Subjects who are currently receiving the class of lipid-lowering medications HMG-CoA reductase inhibitors (statins).
•6. Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.
•7. Subjects with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the subject's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.
•8. Subjects with any of the following gastrointestinal disorders:
•1. Active malabsorption (e.g. short gut) syndrome.
•2. Uncontrolled diarrhea (excess of 4 stools/day)
•3. Gastritis, ulcerative colitis, Chron's disease or hemorrhagic coloproctitis
•4. History of gastric or small bowel surgery involving any extent of gastric or small bowel resection
+1 more criteria

Locations (20)

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

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

Key Dates

Start Date

October 30, 2024

Primary Completion Date

November 1, 2030

Completion Date

November 1, 2035

Last Updated

March 2, 2026

Enrollment

104

ESTIMATED participants

Conditions

NeuroblastomaEwing SarcomaOsteosarcomaRhabdomyosarcomaLiposarcoma

Interventions

Silmitasertib

DRUG

Irinotecan

DRUG

Temozolomide

DRUG

Vincristine

DRUG

Contacts

BCC Enroll

CONTACT

7175310003 BCCEnroll@pennstatehealth.psu.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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