NCT06541262 · Milton S. Hershey Medical Center
Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
What this study is about
The purpose of this study is to evaluate the experimental drug, silmitasertib (a pill taken by mouth), in combination with FDA approved drugs for solid tumors. An experimental drug is one that has not been approved by the U.S.
View original scientific description
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.
Interventions
DRUG
Silmitasertib
Capsules
DRUG
Irinotecan
IV
DRUG
Temozolomide
Oral or IV
DRUG
Vincristine
IV
Primary outcome measures
Phase I- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 2 years plus 30 days
To characterize the safety profile of silmitasertib in combination with chemotherapy
Phase I- Number of Participants with Dose Limiting Toxicities to determine RP2D
Time frame: 21 days
To determine the Recommended Phase 2 Dose (RP2D) of silmitasertib in combination with chemotherapy
Phase II- Determine the Overall Response Rate (ORR) of Participants using INRC
Time frame: 2 years
To evaluate the efficacy of silmitasertib in combination with chemotherapy in 2 disease cohorts, based upon Overall response rate (ORR)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 defi
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Oakland, California
- San Diego, California
- Hartford, Connecticut
- Gainesville, Florida
- Miami, Florida
- Orlando, Florida
- St. Petersburg, Florida
- Tampa, Florida
- Honolulu, Hawaii
- Louisville, Kentucky
And 9 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations