Actively Recruiting
Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
Led by Milton S. Hershey Medical Center · Updated on 2026-04-09
104
Participants Needed
21
Research Sites
574 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Less than 30 years old at initial diagnosis
- Confirmed diagnosis of relapsed or refractory solid tumors: Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, or Liposarcoma
- Disease assessment completed after last therapy and before starting study treatment
- Relapsed or refractory neuroblastoma as defined by specific criteria including prior treatments and staging
- Relapsed or refractory Ewing sarcoma
- Measurable or evaluable disease by CT, MRI, MIBG, PET, or bone marrow biopsy
- Fully recovered from prior therapies according to specified timelines
- Lansky or Karnofsky Performance Scale score of 50 or higher
- Adequate organ function including cardiac, hematological, liver, and renal criteria
- Negative pregnancy test for those of childbearing potential and agreement to use effective contraception
- Written informed consent obtained
You will not qualify if you...
- Currently receiving another investigational drug
- Currently receiving other anticancer agents or not recovered from prior therapy effects
- Receiving Vitamin K antagonists (warfarin) or statins
- Uncontrolled infection
- Unable to comply with safety monitoring or likely to have poor compliance
- Serious unrelated systemic illnesses or organ dysfunction
- Gastrointestinal disorders such as active malabsorption, uncontrolled diarrhea, gastritis, ulcerative colitis, Crohn's disease, hemorrhagic coloproctitis, or history of gastric/small bowel surgery
- Lactating and unwilling to avoid breastfeeding
- History of any other malignancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 21 locations
1
University of Alabama/Children's of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
3
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
4
Rady Children's Hospital
San Diego, California, United States, 92123
Actively Recruiting
5
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
6
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
7
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
8
All Children's Hospital Johns Hopkins Medicine
St. Petersburg, Florida, United States, 33701
Actively Recruiting
9
St. Joseph's Children's Hospital
Tampa, Florida, United States, 33614
Actively Recruiting
10
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96813
Actively Recruiting
11
Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine
Louisville, Kentucky, United States, 40202
Actively Recruiting
12
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
13
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States, 63104
Actively Recruiting
14
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
15
Penn State Milton S. Hershey Medical Center and Children's Hospital
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
16
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
17
Monroe Carrell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Actively Recruiting
18
Children's Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
19
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
20
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Actively Recruiting
21
UHC Sainte-Justine
Montreal, Quebec, Canada, QC H3S 2G4
Actively Recruiting
Research Team
B
BCC Enroll
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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