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RECRUITING Phase 1

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

NCT06541262 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 104 participants
Start Date 2024-10-30
Est. Completion 2035-11-01
Phase Phase 1

Sponsor

Milton S. Hershey Medical Center

277 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06541262

The ClinicalTrials.gov registry entry for NCT06541262 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 277 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06541262 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, California, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06541262?

The interventions under investigation include: Temozolomide (DRUG), Vincristine (DRUG), Silmitasertib (DRUG), Irinotecan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06541262?

This trial is sponsored by Milton S. Hershey Medical Center, which has 277 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial