PRGN-2009 and bintrafusp alfa for patients with advanced or metastatic human papillomavirus-associated cancer.

ABSTRACT:

Background

This first-in-human phase 1 study (NCT04432597) evaluated the safety and recommended phase 2 dose (RP2D) of PRGN-2009, a gorilla adenoviral-vector targeting oncoproteins E6, E7 (human papillomavirus (HPV)16/18) and E5 (HPV16), as monotherapy (Arm 1A) and combined with the bifunctional TGF-β "trap"/anti-PD-L1 fusion protein bintrafusp alfa (BA; Arm 1B), in patients with recurrent/metastatic HPV-associated cancer.

Methods

Patients with ≥ 1 prior treatment (immunotherapy allowed) received PRGN-2009 (1 × 10¹¹ particle units or 5 × 10¹¹ particle units, subcutaneously) every 2 weeks for 3 doses, then every 4 weeks (Arm 1A), or PRGN-2009 (RP2D, schedule per Arm 1A) and BA (1200 mg, intravenously) every 2 weeks (Arm 1B). Primary endpoints were safety

SUBMITTER: Floudas CS 

PROVIDER: S-EPMC11928712 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature