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International Phase I Trial of Dinutuximab Beta With VDC/IE in GD2-Positive Ewing Sarkoma

NCT06839703 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-02-21

No results posted yet for this study

Summary

The goal of the study is to investigate the feasibility, toxicity, and biological activity of the treatment with dinutuximab beta in combination with standard chemotherapy in EWS to give high-risk patients with a GD2 positiv pumor a benefit in treatment. Within the study is tested with three different dosages in a 3+3 design with three pre-defined dose levels.

Conditions

  • High-risk GD2-Positive Ewing Sarcoma

Interventions

DRUG

Dinutuximab beta

Dinutuximab beta is added in different dosages to the standard chemotherapy

Sponsors & Collaborators

  • Prof. Dr. Dirk Reinhardt

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2027-03-01
Completion
2027-03-01

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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 NCT06839703 on ClinicalTrials.gov