OncoMatch/Clinical Trials/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
Is NCT06650514 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies OMO-103 for osteosarcoma.
Treatment: OMO-103 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Osteosarcoma
Disease stage
Grade: high-grade
advanced high-grade osteosarcoma not suitable for local treatments with curative intent
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy (cisplatin, anthracycline) — standard
Confirmed disease progression by radiological report to at least one line of standard chemotherapy containing cisplatin and anthracycline
Cannot have received: systemic anti-cancer therapy
Treatment with systemic anti-cancer therapy within three weeks prior to study drug administration for chemotherapy and 5 half-lives for targeted therapies
Cannot have received: radiation therapy
Exception: Localised palliative radiotherapy to nontarget lesions is allowed
Radiation therapy within four weeks prior to study entry. Localised palliative radiotherapy to nontarget lesions is allowed
Lab requirements
Blood counts
Adequate organ function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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