Debio 0123 + Carboplatin for Patients with Advanced Solid Tumors: Safety, Preliminary Efficacy and Determination of Recommended Phase 2 Dose

Presented at ESMO 2024

Hans Gelderblom1, Omar Saavedra2, Mathilde Jalving3, Ingrid Desar4, Jourik A. Gietema3, Arjun Oberoi2, Carla M.L. van Herpen4, Judith Kroep1, Rikke Frederiksen Franzen5, Anne Bellon5, Sandrine Micallef5, Tri Tat5, Vito Dozio5, Noemie Luong5, Esteban Rodrigo Imedio5

1 Leiden University Medical Center, Leiden, The Netherlands;
2 Vall d’Hebron Institute of Oncology, Barcelona, Spain;
3 University Medical Center Groningen, Groningen, The Netherlands;
4 Radboud University Medical Centre, Nijmegen, The Netherlands;
5 Debiopharm International SA, Lausanne, Switzerland

Background

Cell cycle defects are common in cancer and cells rely on checkpoint proteins, such as WEE1, to avoid excess DNA damage. WEE1 inhibition abrogates S phase and G2-M checkpoints, leading to mitotic catastrophe and apoptosis. Debio 0123 is an oral, highly selective, brain-penetrant WEE1 inhibitor that has shown synergy with CP preclinically. Debio 0123-101 (NCT03968653) is a Phase 1 study evaluating Debio 0123 + CP. Arm A dose escalation (DE) data were reported at ASCO 2023; here, complete Debio 0123 DE and RP2D data are described.