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

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. P

Trial Details

NCT ID
NCT06650514
Phase
PHASE2
Sponsor
Vall d'Hebron Institute of Oncology
Status
RECRUITING
Cancer Type
Osteosarcoma Sarcoma
Interventions
  • OMO-103
Locations (sample)
  • Barcelona, Spain|41.38879,2.15899

Key Eligibility Criteria

  • Provision of signed and dated informed consent form.
  • Age ≥12 years at time of informed consent.
  • Histologically proven, advanced high-grade osteosarcoma not suitable for local treatments with curative intent
  • Confirmed disease progression by radiological report to at least one line of standard chemotherapy containing cisplatin and anthracycline, and no m…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Osteosarcoma Sarcoma Trials on Trialify →