Phase 1/2 Study to Evaluate Safety, PK and Efficacy of the MYC-Inhibitor OMO-103 in Solid Tumours

Summary

This study is an open label, two-part, First in Human (FIH) Phase 1/2 dose-finding study designed to determine the safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and proof-of-concept (POC) of OMO-103 in patients with advanced solid tumours.

Timeline

Start

2021-04-28

Primary completion

2022-12-15

Completion

2023-01-11

Outcome

Outcome not reported

Stopped (Business): “Phase 1completed; sponsor decided to change strategy to a combination study”

Publications

• Avolio E, Bassani B, Campanile M, Mohammed KA, Muti P, Bruno A, Spinetti G, Madeddu P. Shared molecular, cellular, and environmental hallmarks in cardiovascular disease and cancer: Any place for drug repurposing? Pharmacol Rev. 2025 Mar;77(2):100033. doi: 10.1016/j.pharmr.2024.100033. Epub 2024 Dec 24.
• Garralda E, Beaulieu ME, Moreno V, Casacuberta-Serra S, Martinez-Martin S, Foradada L, Alonso G, Masso-Valles D, Lopez-Estevez S, Jauset T, Corral de la Fuente E, Doger B, Hernandez T, Perez-Lopez R, Arques O, Castillo Cano V, Morales J, Whitfield JR, Niewel M, Soucek L, Calvo E. MYC targeting by OMO-103 in solid tumors: a phase 1 trial. Nat Med. 2024 Mar;30(3):762-771. doi: 10.1038/s41591-024-02805-1. Epub 2024 Feb 6.

Drugs

Indications