OncoMatch/Clinical Trials/NCT06541262
Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
Is NCT06541262 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including Silmitasertib and Irinotecan for neuroblastoma.
Treatment: Silmitasertib · Irinotecan · Temozolomide · Vincristine — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Neuroblastoma
Sarcoma
Osteosarcoma
Rhabdomyosarcoma
Demographics
Prior therapy
Cannot have received: investigational drug
Subjects who are currently receiving another investigational drug are excluded from participation
Cannot have received: other anticancer agents
Subjects who are currently receiving other anticancer agents are not eligible
Lab requirements
Blood counts
ANC ≥750/μL
Kidney function
eGFR ≥ 70 mL/min/1.73 m2 (Bedside Schwartz equation for <17 years, Cockcroft and Gault formula for ≥17 years, or 24 hour urine Creatinine clearance ≥ 70 mL/min/1.73 m2)
Liver function
AST and ALT <5x upper limit of normal
Cardiac function
QTcF ≤ 480 msc
Subjects must have adequate organ function at the time of enrollment: * Cardiac: Subjects must have a QTcF ≤ 480 msc. * Hematological: Hematological recovery as defined by ANC ≥750/μL * Liver: Adequate liver function as defined by AST and ALT <5x upper limit of normal * Renal: Subjects must have adequate renal function defined as: * estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (for subjects < 17 years old) (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Bedside Schwartz equation is: [(0.413) X (Height in cm)] / SCr * estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (for subjects ≥17 years old (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Cockcroft and Gault formula is: [(140-age) x (Wt in kg) x (0.85 if female)] / (72 x SCr) * OR a 24 hour urine Creatinine clearance ≥ 70 mL/min/1.73 m2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama/Children's of Alabama · Birmingham, Alabama
- Phoenix Children's Hospital · Phoenix, Arizona
- UCSF Benioff Children's Hospital Oakland · Oakland, California
- Rady Children's Hospital · San Diego, California
- Connecticut Children's Hospital · Hartford, Connecticut
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06541262 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational drug, other anticancer agents disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 30 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages