NCT06650514

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Vall d'Hebron Institute of Oncology · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteosarcoma
• Osteosarcoma in Children

Interventions

Type	Name	Description
DRUG	OMO-103	OMO-103 administered at the recommended phase 2 dose (6.5 mg/kg as a weekly intravenous infusion in 28-day cycles).

Timeline

• Start date: 2024-12-27
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-10-21
• Last updated: 2025-01-10

Locations

1 site across 1 country: Spain