Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma

Conditions

• Locally Advanced Unresectable Pancreatic Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Padeliporfin Vascular Targeted Photodynamic (VTP) therapy — COMBINATION_PRODUCT
  The laser light fiber with inflatable balloon to dam SMA blood flow during light illumination will be placed by an Interventional Radiologist in the SMA via a transfemoral artery approach. The balloon will be inflated to impede blood flow for total of 10 minutes during light illumination

Study Details

This is a prospective, multicenter, non-randomized, open label light dose escalation phase I trial to evaluate the safety and preliminary efficacy of Padeliporfin vascular targeted photodynamic therapy (VTP) applied via endovascular fiber placement within a dilatation catheter, through the target artery(superior mesenteric artery (SMA), celiac artery (CA) or common hepatic artery (CHA)). The investigators will evaluate safety and preliminary efficacy of Padeliporfin VTP administered endovascularly using light dose escalation.

Key Dates

Start date

May 15, 2024

Status verified

Feb 2026

Primary completion

May 30, 2026

Completion

Oct 30, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A
  will be a monotherapy light dose escalation with single dose of Padeliporfin at light laser doses of 200, 400 and 600 mW/cm for 10 minutes. Part A will proceed with light dose escalation and will continue until the maximum tolerated light dose (MTD) and/or recommended phase 2 dose (RP2D) is defined.
• Experimental: Part B
  will be a dose expansion part at MTD/RP2D dose level identified in Part A to further assess the safety, tolerability, and treatment effect of the MTD and/ or RP2D

Primary Outcome Measure

Safety of endovascularly applied Padeliporfin VTP ablation [ Time Frame: Day 30 ]

Central Contacts

• Eyal Morag, MD
  +972 54 2056619
  [email protected]

Locations (2)

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