A phase 2 study to investigate the efficacy and safety of acoustic cluster therapy with modified FOLFIRINOX in patients with locally advanced pancreatic cancer.

TPS795 Background: Patients with advanced pancreatic ductal adenocarcinoma (PDAC) face limited treatment options due to the tumor’s dense stromal microenvironment, which impedes drug penetration and reduces chemotherapy efficacy (Kane et al., 2020). Acoustic cluster therapy (ACT) is an investigational ultrasound-mediated drug delivery platform combining a proprietary intravenous formulation (PS101) with focused ultrasound to enhance chemotherapeutic delivery. PS101 consists of microclusters of perfluorobutane microbubbles and perfluoromethylcyclopentane microdroplets. After injection, diagnostic-frequency ultrasound (~2 MHz, diagnostic mechanical index (MI)) is applied over the tumor site. Upon reaching the tumor vasculature, ultrasound activation causes the microclusters to expand into transient ACT bubbles (~22 μm diameter), which deposit in