drugset / Trial / 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
Phase 2
Recruiting
10 enrolled
Vall d'Hebron Institute of Oncology
Curing Kids' Cancer Foundation · collabDana-Farber Cancer Institute · collabMemorial Sloan Kettering Cancer Center · collabOregon Health and Science University · collabOsteosarcoma Institute · collabPeptomyc S.L. · collabThe Kristen Ann Carr Fund · collabThe Morgan Adams Foundation · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-12-27
- Primary completion
- 2026-06
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OMO-103 | Protein / enzyme biologic | 6.5 mg/kg | Intravenous |