# Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas

> **NCT06709495** · PHASE1,PHASE2 · RECRUITING · sponsor: **David S Shulman, MD** · enrollment: 63 (estimated)

## Conditions studied

- Sarcoma
- Sarcoma, Ewing
- Desmoplastic Small Round Cell Tumor
- Refractory Sarcoma
- Osteosarcoma
- Rhabdomyosarcoma

## Interventions

- **DRUG:** PEEL-224
- **DRUG:** Temozolomide
- **DRUG:** Vincristine
- **BIOLOGICAL:** Pegfilgrastim
- **BIOLOGICAL:** Filgrastim

## Key facts

- **NCT ID:** NCT06709495
- **Lead sponsor:** David S Shulman, MD
- **Sponsor class:** OTHER
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-01-27
- **Primary completion:** 2028-11-01
- **Final completion:** 2029-09-01
- **Target enrollment:** 63 (ESTIMATED)
- **Last updated:** 2026-02-19

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06709495

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06709495, "Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT06709495. Licensed CC0.

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