Overview

A Phase 2 Pilot Study to Evaluate the Safety and the Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients With Advanced High-Grade Osteosarcoma

Status:
RECRUITING

Trial end date:
2026-12-01

Target enrollment:

Participant gender:

Summary

This is an open-label, unicentric, single-arm Phase 2 pilot study to serve as a proof-of-concept of OMO-103 safety and activity in patients with advanced high-grade osteosarcoma. Patients will be treated at the RP2D (6.5 mg/kg as a weekly IV infusion) of OMO-103 to estimate anti-tumour activity and further characterise the safety, tolerability, PK, and PD of OMO-103 in advanced high-grade osteosarcoma patients. Ten (10) evaluable patients will be enrolled. At least 30% of patients will be \<18 years old. The first three patients 12-15 years of age will undergo additional safety monitoring. Patients will be treated until progression by RECIST v1.1 or intolerable toxicity.

Phase:

PHASE2

Details

Lead Sponsor:

Vall d'Hebron Institute of Oncology

Collaborators:

Curing Kids' Cancer Foundation
Dana-Farber Cancer Institute
Memorial Sloan Kettering Cancer Center
Oregon Health and Science University
Osteosarcoma Institute
Peptomyc S.L.
The Kristen Ann Carr Fund
The Morgan Adams Foundation