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Study identifier: NCT06650514 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Osteosarcoma · Osteosarcoma in Children  ·  Sponsor: Vall d'Hebron Institute of Oncology

PhasePhase 2
Planned participants10
Who can joinAll sexes, 12 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Claudia M Valverde  ·  +34932746085  ·  cvalverde@vhio.net

Always discuss trial participation with your own doctor first.

Locations (1)

Hospital Universitari Vall d'HebronBarcelona, SpainRecruiting

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Source record: clinicaltrials.gov/study/NCT06650514