Evaluation of the Safety and Efficacy of Mifamurtide Versus Standard Treatment With Sorafenib in Patients With High-risk Osteosarcoma

NCT07787429 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-26

No results posted yet for this study

Summary

Prospective, open, interventional, randomized, non-commercial trial

Conditions

Interventions

DRUG

Mifamurtide

Mifamurtide is a synthetic analog of muramyl dipeptide, which works by stimulating the immune system to destroy cancer cells. The exact mechanism of this activation in humans is unknown. The MEPACT product is a liposomal form of mifamurtide specifically formulated to reach macrophages in vivo after administration by intravenous infusion.

DRUG

Sorafenib

Sorafenib is a small-molecule, broad-spectrum tyrosine kinase inhibitor that slows cancer cell growth and reduces angiogenesis. Sorafenib is unique among new kinase inhibitors as it simultaneously inhibits the Raf, Mek, and Erk kinase pathways.

Sponsors & Collaborators

  • Maria Sklodowska-Curie National Research Institute of Oncology

    collaborator OTHER
  • Anna Raciborska

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2033-07-31
Completion
2033-07-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

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 NCT07787429 on ClinicalTrials.gov