Intra-Arterial (IA) Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP): Ongoing Multicenter, Phase I Light Dose Escalation Study in Unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC)

Monday, April 13, 2026

4:21 PM - 4:30 PM ET

Location: 718B

Presenting Author(s)

Nadine Abi-Jaoudeh, MD, FSIR (she/her/hers)

Professor of Radiology
University of California, United States

Author/Co-author(s)

JV

Jennifer Valerin, MD, PhD

Assistant Clinical Professor
Division of Hematology/Oncology, Department of Medicine, University of California Irvine, United States
DP

Dina Preise, PhD

Head clinical and non clinical sciences
Impact Biotech, Israel
GA

Genia Alpert, MD, PhD

Medical Director
Impact Biotech, Israel
KB

Keren Brook, MS

Clinical project lead
Impact Biotech, Israel
NW

Nick Weinberger, MS

Medical Science Liason
Impact Biotech, Israel
DP

David Perry, MD

Medical monitor
Impact Biotech, Israel
AC

April Choi, MD

Oncologist
University of California Irvine, Irvine, CA, United States
AS

Avigdor Scherz, PhD

Professor (EProfessor of meritus), Faculty of Biochemistry
Weizmann Institute of Science, Israel
EM

Eyal Morag, MD

CMO
Impact Biotech, Israel
VC

Vincent Chung, MD

Oncology
City of Hope, United States
LM

Laleh Melstrom, MD

Oncology
City of Hope, United States
JK

Jonathan Kessler, MD

Interventional Radiology Attending
City of Hope Medical Center, United States
DI

David K. Imagawa, MD, PhD

Chief of Hepatobiliary and Pancreas Surgery/Islet Cell Transplantation
Division of Hepatobiliary and Pancreas Surgery, Surgery, United States

Purpose:

This clinical study aims to evaluate safety and preliminary efficacy of intra-arterial (IA) Padeliporfin Vascular-Targeted Photodynamic (VTP) therapy as a novel tool for downstaging unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC).

Materials and Methods:

NCT05919238 is an ongoing Phase I light dose-escalation study. Key inclusion criteria are stage III LA-PADC with vascular encasement >180 in head/uncinate process of the pancreas for the total contact length up to 3cm. VTP is applied via IA fiber placement within a dilatation balloon, in the target artery tangential to the tumor. Padeliporfin is injected intravenously at a dose of 4 mg/kg and locally activated by 753nm laser illumination for two 5-minute cycles separated by 1-minute break. The laser is activated at various levels of light dose ranging from 200 to 600 mW/cm. The primary objectives include evaluation of safety and Maximum Tolerated light Dose (MTD) and/or recommended phase 2 light dose (RP2D) for optimal IA activation of Padeliporfin. Secondary objectives are to determine rate of surgical downstaging and resectability as well as the pattern of disease progression following VTP treatment, based on pre- and post-VTP contrast computed tomography (CT) scans. The study will comprise two parts: part A (light dose escalation) with 3+3 schema; in part B the optimal light dose, derived in Part A, will be used in an additional cohort of patients to further evaluate safety and preliminary efficacy.

Results:

Three patients have been treated with low light dose, 200mW/cm. Fiber deployment and Padeliporfin VTP were completed successfully with no Padeliporfin or VTP-related serious adverse events (AE). One transient Grade 1 photosensitivity reaction was reported, in line with previous findings from clinical studies for other indications of Padeliporfin. No complications related to arterial injury, thrombosis, ischemia, or other VTP-related morbidity were observed.

Two out of the 3 patients were resected after VTP. One had disease progression unrelated to VTP procedure and remained a non-surgical candidate.

Conclusion:

IA Padeliporfin-VTP was technically feasible in three stage III LA-PDAC patients, without serious drug and treatment-related AE, paving the way for new therapeutic interventions.