BETA PRIME: Phase I study of AdAPT-001 as monotherapy and combined with a checkpoint inhibitor in superficially accessible, treatment-refractory solid tumors.
AdAPT-001 is an investigational therapy consisting of a replicative type 5 adenovirus armed with a TGF-β receptor-immunoglobulin Fc fusion trap, designed to neutralize isoforms 1 and 3 of the profibrotic and immunosuppressive cytokine, TGF-β. In preclinical studies with an immunocompetent mouse model, AdAPT-001 eradicated directly treated 'cold' tumors as well as distant untreated tumors, and, from its induction of systemic CD8+ T cell-mediated antitumor immunity, protected the mice from rechallenge with tumor cells. AdAPT-001 also sensitized resistant tumors to checkpoint blockade. This manuscript describes the rationale and design of the first-in-human phase I, dose-escalation and dose-expansion study of AdAPT-001 alone and in combination with a checkpoint inhibitor in adults with treatment-refractory superficially accessible solid tumors.
Trial registration: ClinicalTrials.gov NCT04673942.
Keywords: AdAPT-001; BETA PRIME; TGF-β trap; abscopal effect; oncolytic adenovirus; solid tumors; study protocol.
Kesari, Santosh; Bessudo, Alberto; Gastman, Brian R; Conley, Anthony P; Villaflor, Victoria M; Nabell, Lisle M; Madere, DeLisa; Chacon, Emma; Spencer, Christina; Li, Li; Larson, Christopher; Reid, Tony; Caroen, Scott; Oronsky, Bryan; Stirn, Meaghan; Williams, Jeannie; and Barve, Minal A, "BETA PRIME: Phase I study of AdAPT-001 as monotherapy and combined with a checkpoint inhibitor in superficially accessible, treatment-refractory solid tumors." (2022). Articles, Abstracts, and Reports. 6365.