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First-in-human phase I/IIa trial to evaluate the safety and initial clinical activity of DuoBody®-PD-L1×4–1BB (GEN1046) in patients with advanced solid tumors
(BMJ, 2020) Jure-Kunkel, M. (María); Ahmadi, T. (Tahamtan); Calvo, E. (Emiliano); Forssmann, U. (Ulf); Ben-Ami, E. (Eytan); Geva, R. (Ravit); Türec, Ö. (Özlem); Maurice-Dror, C. (Corinne); Garralda, E. (Elena); Melero, I. (Ignacio); Sahin, U. (Ugur); Niewood, M. (Michelle); Lorusso, P. (Patricia)
Agonistic 4-1BB monoclonal antibodies were preclinically validated as promising cancer immunotherapies, both as monotherapy and as potentiators of the activity of PD-(L) 1–blocking agents. However, toxicity and a narrow therapeutic window have hampered their clinical development. DuoBodyPD-L1×4-1BB, a first-in-class, bispecific, next-generation checkpoint immunotherapy, was designed to overcome these limitations by activating T cells through conditional 4-1BB costimulation, while simultaneously blocking the PD-L1 axis. We present preliminary data from the ongoing, first-in-human, open-label, phase I/IIa trial of DuoBody-PD-L1×4-1BB in advanced solid tumors (NCT03917381).