Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06541262 · ClinicalTrials.gov registry record · Phase 1
Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
A Phase 1 study of Neuroblastoma and Osteosarcoma, sponsored by Milton S. Hershey Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 104
- Enrollment target
- 20
- Study locations
NCT06541262: Recruiting Phase 1 study of Neuroblastoma and Osteosarcoma, sponsored by Milton S. Hershey Medical Center.
NCT06541262 is a Phase 1 study of Neuroblastoma and Osteosarcoma that is actively recruiting participants, run by Milton S. Hershey Medical Center. The registered enrollment target is 104 participants, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06541262, a Phase 1 study of Neuroblastoma and Osteosarcoma, is actively recruiting participants, sponsored by Milton S. Hershey Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 104 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Primary Outcome
To characterize the safety profile of silmitasertib in combination with chemotherapy
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Vincristine
- DRUG Silmitasertib
- DRUG Irinotecan
Study Locations (20)
Florida
- University of Florida - Gainesville
- Nicklaus Children's Hospital - Miami
- Arnold Palmer Hospital for Children - Orlando
- St. Joseph's Children's Hospital - Tampa
California
- UCSF Benioff Children's Hospital Oakland - Oakland
- Rady Children's Hospital - San Diego
Missouri
- Children's Mercy Hospitals and Clinics - Kansas City
- Cardinal Glennon Children's Medical Center - St Louis
Alabama
- University of Alabama/Children's of Alabama - Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
Hawaii
- Kapiolani Medical Center for Women and Children - Honolulu
Kentucky
- Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine - Louisville
New Jersey
- Hackensack University Medical Center - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2024-10-30 |
| Est. Completion | 2035-11-01 |
| Phase | Phase 1 |
What NCT06541262 shows while recruiting
NCT06541262 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (56% lower).
The record links to 5 conditions, with Neuroblastoma appearing as the primary indexed condition, and to 4 interventions - of which Temozolomide is the first listed.
NCT06541262 names 20 study sites across 15 states, led by Florida, California, Missouri.
Frequently Asked Questions
What is clinical trial NCT06541262 about?
NCT06541262 is a clinical study titled "Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors". 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 authorit...
What is the current status of trial NCT06541262?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2024-10-30. Estimated completion is 2035-11-01.
What conditions does trial NCT06541262 study?
This clinical trial studies the following conditions: Neuroblastoma, Osteosarcoma, Rhabdomyosarcoma, Ewing Sarcoma, Liposarcoma.
What interventions are being tested in trial NCT06541262?
The interventions under investigation include: Temozolomide (DRUG), Vincristine (DRUG), Silmitasertib (DRUG), Irinotecan (DRUG).
Who is sponsoring clinical trial NCT06541262?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06541262 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06541262's enrollment target sits among peer trials
104 28th of 94 higher than 67 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)
RECRUITING · Phase 1
-
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Solid Tumors
RECRUITING · Phase 1
-
Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE)
RECRUITING · Phase 1
-
Alpha/Beta T and B Cell Depletion With Zoledronic Acid for Solid Tumors
RECRUITING · Phase 1
-
Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma
RECRUITING · Phase 1
-
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03403686 · 104 participants
Liver X Receptor (LXR) as a Novel Therapeutic Target in Diabetic Retinopathy (DR)
- NCT04228367 · 104 participants · NA
JuggerStitch Post Market Clinical Follow-up Study
- NCT04268849 · 104 participants · Phase 3
Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient
- NCT04390724 · 104 participants
Optimizing Y90 Therapy for Radiation Lobectomy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI