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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 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-02-19

No results posted yet for this study

Summary

This research is being done to test a new drug called PEEL-224 in combination with two commercially available drugs, Vincristine and Temozolomide, and to determine how effective this combination of drugs is at treating Ewing Sarcoma (EWS) and Desmoplastic Small Round Cell Tumor (DSRCT), as well as multiple other kinds of sarcomas.

The names of the study drugs and biological agents involved in this study are:

* PEEL-224 (a type of Topoisomerase 1 inhibitor)
* Vincristine (A type of vinca alkaloid)
* Temozolomide (A type of alkylating agent)
* Pegfilgrastim or Filgrastim (types of Myeloid growth factors)

Conditions

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

Interventions

DRUG

PEEL-224

Topoisomerase 1 inhibitor, 200mg amber vial, via intravenous (into the vein) infusion per protocol.

DRUG

Temozolomide

Alkylating agent, 5, 20, 100, 140, 180, or 250 mg capsule, taken orally per standard of care.

DRUG

Vincristine

Vinca alkaloid, 1 or 2mL vials, via intravenous (into the vein) infusion per institutional policy.

BIOLOGICAL

Pegfilgrastim

Myeloid growth factor administered per institutional standards.

BIOLOGICAL

Filgrastim

Myeloid growth factor administered per institutional standards.

Sponsors & Collaborators

  • Peel Therapeutics Inc

    collaborator INDUSTRY

  • David S Shulman, MD

    lead OTHER

Principal Investigators

  • David Shulman, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2028-11-01
Completion
2029-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT06709495 on ClinicalTrials.gov