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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: Recruiting Phase 1 study of Refractory Neuroblastoma and Relapsed Neuroblastoma, sponsored by Theodore Laetsch.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The observation of a dose-limiting toxicity (DLT) or lack of observation of DLT in the period between treatment initiation up to initiation of cycle 2 treatment. A dose limiting toxicity (DLT) describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
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 |
What NCT06721689 shows while recruiting
NCT06721689 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, above the 46-participant average among 9 other Refractory Neuroblastoma trials with a reported enrollment target (28% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT06721689's enrollment target sits among peer trials
59 3rd of 9 higher than 7 of 9 other Refractory Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory 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.
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