BETA PRIME: Phase I study of AdAPT-001 as monotherapy and combined with a checkpoint inhibitor in superficially accessible, treatment-refractory solid tumors.

Publication Title

Future Oncol

Authors

Santosh Kesari, Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute/Pacific Neuroscience Institute, 2200 Santa Monica Boulevard, Santa Monica, CA, 90404, USAFollow
Alberto Bessudo
Brian R Gastman
Anthony P Conley
Victoria M Villaflor
Lisle M Nabell
DeLisa Madere, Saint John's Cancer Institute at Providence Saint John's Health Center, Santa Monica, CA 90404, USA.Follow
Emma Chacon, Saint John's Cancer Institute at Providence Saint John's Health Center, Santa Monica, CA 90404, USA.Follow
Christina Spencer
Li Li
Christopher Larson
Tony Reid
Scott Caroen
Bryan Oronsky
Meaghan Stirn
Jeannie Williams
Minal A Barve

Document Type

Article

Publication Date

8-11-2022

Keywords

california; sjci

Abstract

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.

Clinical Institute

Cancer

Specialty/Research Institute

Oncology