OncoMatch/Clinical Trials/NCT06541262
Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
Is NCT06541262 recruiting? Yes, currently enrolling (May 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
Cancer type
Neuroblastoma
Sarcoma
Osteosarcoma
Rhabdomyosarcoma
Prior therapy
Must have received: multi-agent chemotherapy — induction (neuroblastoma)
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
Must have received: standard of care therapy — sarcoma
Subjects that have relapsed following standard of care therapy or having progressed during standard of care therapy. Standard of care therapy for sarcoma includes multi-agent chemotherapy with local control consisting of either surgery or radiation therapy.
Lab requirements
Blood counts
ANC ≥750/μL
Kidney function
eGFR (Bedside Schwartz equation or radioisotope GFR) ≥ 70
Liver function
AST and ALT <5x upper limit of normal
Cardiac function
QTcF ≤ 480 msec
Cardiac: QTcF ≤ 480 msc. Hematological: ANC ≥750/μL. Liver: AST and ALT <5x upper limit of normal. Renal: eGFR (Bedside Schwartz equation or radioisotope GFR) ≥ 70.
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
- University of Florida · Gainesville, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
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