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NCT06721689 · ClinicalTrials.gov registry record · Phase 1
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
A Phase 1 study of Refractory Neuroblastoma and Relapsed Neuroblastoma, sponsored by Theodore Laetsch.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT06721689 is a Phase 1 study of Refractory Neuroblastoma and Relapsed Neuroblastoma that is actively recruiting participants, run by Theodore Laetsch. The registered enrollment target is 59 participants, above the 46-participant average among 9 other Refractory Neuroblastoma trials with a reported enrollment target (28% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06721689, a Phase 1 study of Refractory Neuroblastoma and Relapsed Neuroblastoma, is actively recruiting participants, sponsored by Theodore Laetsch.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG Vincristine
- DRUG Temozolomide (TMZ)
- DRUG PEEL-224
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2025-03-23 |
| Est. Completion | 2031-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06721689
The ClinicalTrials.gov registry entry for NCT06721689 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 46-participant average among 9 other Refractory Neuroblastoma trials with a reported enrollment target (28% higher). The listed sponsor is Theodore Laetsch, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Refractory Neuroblastoma appearing as the primary indexed condition, and to 3 interventions - of which Vincristine is the first listed.
NCT06721689 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06721689 about?
NCT06721689 is a clinical study titled "PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors". 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 refrac...
What is the current status of trial NCT06721689?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2025-03-23. Estimated completion is 2031-04.
What conditions does trial NCT06721689 study?
This clinical trial studies the following conditions: Refractory Neuroblastoma, Relapsed Neuroblastoma, Refractory Solid Tumors, Relapsed Solid Tumors, Relapsed Rhabdomyosarcoma.
What interventions are being tested in trial NCT06721689?
The interventions under investigation include: Vincristine (DRUG), Temozolomide (TMZ) (DRUG), PEEL-224 (DRUG).
Who is sponsoring clinical trial NCT06721689?
This trial is sponsored by Theodore Laetsch, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06721689 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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