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Silmitasertib with Chemotherapy for Relapsed Solid Tumors in Children and Young Adults

This study is testing an investigational drug called silmitasertib (a pill) in combination with standard chemotherapy drugs like Irinotecan, Temozolomide, and Vincristine. The goal is to see if this combination is safe and effective for children and young adults (up to 30 years old) with certain relapsed or refractory (meaning it came back or didn't respond to previous treatment) solid tumors, including Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, and Liposarcoma. Researchers want to find the best dose of silmitasertib and measure how many participants respond to the treatment. This study is currently unclear regarding its recruitment status and plans to enroll 104 participants.

Study design
This is an interventional study with a planned enrollment of 104 participants. It is designed to evaluate the safety, tolerability, and effectiveness of silmitasertib combined with chemotherapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for at least 2 years and 30 days. The overall response to treatment will be measured for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06541262

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

Recruiting
PHASE1Up to 30InterventionalTreatment
Milton S. Hershey Medical Center
~104 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:SilmitasertibIrinotecanTemozolomideVincristine

At a glance

Recruiting sites
22 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured over 2 years plus 30 days
+2 more outcomes measured

Conditions

Neuroblastoma
Ewing Sarcoma
Osteosarcoma
Rhabdomyosarcoma
Liposarcoma

Explore related trials

Ewing SarcomaLiposarcomaNeuroblastomaOsteosarcomaRhabdomyosarcoma

Where it's being run

22 sites across 16 states
Florida5
California2
Missouri2
Alabama1
Arizona1
Connecticut1
Hawaii1
Kentucky1

Study leadership

  • Chandrika Behura, MD · STUDY_CHAIR · Penn State Health Children's Hospital

Who to contact

BCC Enroll
[email protected]
7175310003
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Relapsed/refractory Neuroblastoma
Relapsed/refractory Ewing sarcoma 3. Tumor assessment:
Measurable tumor by CT or MRI
MIBG or PET that is positive for disease
Bone Marrow biopsy/aspirate that is positive for disease 6. Timing from prior therapy:
Allogeneic: No evidence of active graft vs. host disease
Allogeneic/Autologous: ≥ 2 months must have elapsed since transplant. 6. MIBG Therapy: At least 6 weeks since treatment with MIBG therapy. 7. Subjects must have a Lansky or Karnofsky Performance Scale score of \>/= 50. 8. 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 9. Subjects of childbearing potential must have a negative serum pregnancy test. Subjects of childbearing potential must agree to use effective measures to avoid pregnancy. 10. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all subjects (or subjects' legal representative).

What this trial measures

  • Phase I- Number of Participants with Adverse Events as a Measure of Safety and Tolerability2 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 RP2D21 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 INRC2 years

    To evaluate the efficacy of silmitasertib in combination with chemotherapy in 2 disease cohorts, based upon Overall response rate (ORR)