Clinical Trial

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

Study acronym: Osteomyc
Recruiting Phase 2
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Record status
This record was last updated January 10, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-10-17; most recent amendment 2025-01-08.
Status change: Not Yet Recruiting → Recruiting 2025-01-08
Trial Details
NCT Number NCT06650514
Lead Sponsor Vall d'Hebron Institute of Oncology
Collaborators: Peptomyc S.L., Osteosarcoma Institute, Curing Kids' Cancer Foundation, Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Oregon Health and Science University, The Morgan Adams Foundation, The Kristen Ann Carr Fund
Conditions Osteosarcoma, Osteosarcoma in Children
Enrollment 10 participants
Start Date 2024-12-27
Primary Completion 2026-06 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-01-10