This phase 1 study investigated the safety and tolerability of OMO-103, a MYC inhibitor, in patients with advanced solid tumors. Twenty-two patients received weekly intravenous OMO-103 at six dose levels. The most common adverse events were grade 1 infusion-related reactions. Pharmacokinetics showed nonlinearity with tissue saturation at higher doses. Of 19 evaluable patients, eight showed stable disease at the 9-week assessment. Transcriptomic analysis supported target engagement, and potential pharmacodynamic and predictive response markers were identified. The recommended phase 2 dose was determined to be 6.48 mg/kg.

Elena Garralda, Marie-Eve Beaulieu, Víctor Moreno, Sílvia Casacuberta-Serra, Sandra Martínez-Martín, Laia Foradada, Guzman Alonso, Daniel Massó-Vallés, Sergio López-Estévez, Toni Jauset, Elena Corral de la Fuente, Bernard Doger, Tatiana Hernández, Raquel Perez-Lopez, Oriol Arqués, Virginia Castillo Cano, Josefa Morales, Jonathan R. Whitfield, Manuela Niewel, Laura Soucek, Emiliano Calvo