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PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors

NCT06721689 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-04-15

No results posted yet for this 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

  • Refractory Solid Tumors
  • Relapsed Solid Tumors
  • Relapsed Neuroblastoma
  • Refractory Neuroblastoma
  • Relapsed Rhabdomyosarcoma
  • Refractory Rhabdomyosarcoma

Interventions

DRUG

PEEL-224

PEEL-224 (PEG-\[SN22\]4) is a novel topoisomerase I inhibitor

DRUG

Vincristine

Vincristine is an inhibitor of microtubular formation which is approved by the Food and Drug Administration (FDA) and is commercially available.

DRUG

Temozolomide (TMZ)

Temozolomide is an alkylating agent which is approved by the FDA and is commercially available.

Sponsors & Collaborators

Principal Investigators

  • Jacquelyn Crane, MD · Children's Hospital of Philadelphia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-23
Primary Completion
2030-04-30
Completion
2031-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06721689 on ClinicalTrials.gov