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Recruiting Phase 1Phase 2 Interventional

PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors

ClinicalTrials.gov ID: NCT06721689

Public ClinicalTrials.gov record NCT06721689. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 11, 2026, 8:09 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1/2 Clinical Trial of the Novel Topoisomerase I Inhibitor PEEL-224 as a Single Agent and in Combination With Vincristine and Temozolomide in Children With Refractory, Progressive or Relapsed Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The phase 1 primary objective is to determine the pediatric recommended phase 2 dose (RP2D) of PEEL-224 as a single agent (phase 1A) and in combination with vincristine and temozolomide (phase 1B). The phase 2 primary objective is to estimate the objective response rate (ORR) in children with refractory, progressive and relapsed NBL and rhabdomyosarcoma (RMS) treated with the RP2D of PEEL-224 in combination with vincristine and temozolomide.

Study identification

NCT ID
NCT06721689
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Theodore Laetsch
Other
Enrollment
59 participants

Conditions and interventions

Eligibility (public fields only)

Age range
1 Year to 30 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 22, 2025
Primary completion
Mar 31, 2030
Completion
Mar 31, 2031
Last update posted
Jul 21, 2026

2025 – 2031

United States locations

U.S. sites
7
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
Cedars-Sinai Medical Center Los Angeles California 90048 Recruiting
University of California, San Francisco San Francisco California 94143 Recruiting
Boston Children's Hospital Boston Massachusetts 02115 Not yet recruiting
Dana-Farber Cancer Institute Boston Massachusetts 02215 Not yet recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 Recruiting
Texas Children's Hospital Houston Texas 77030 Recruiting
University of Utah Hospital Salt Lake City Utah 84132 Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06721689, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 21, 2026 · Synced Sep 11, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06721689 live on ClinicalTrials.gov.

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