Padeliporfin VTP for Unresectable Pancreatic Cancer

This study is testing a new treatment called Padeliporfin Vascular Targeted Photodynamic (VTP) therapy for people with locally advanced pancreatic cancer that cannot be removed by surgery. This treatment involves placing a special fiber into an artery (like the superior mesenteric artery) to deliver light, after you receive Padeliporfin intravenously. The light activates the Padeliporfin to treat the tumor. Researchers want to find out how safe this treatment is and the best light dose to use. About 30 people will participate. You may be able to join if you are 18 or older and have been diagnosed with Stage III pancreatic ductal adenocarcinoma.

Study design
This is a Phase 1 study, meaning it's an early-stage trial. It is not randomized and is open-label, meaning both you and the study team will know what treatment you are receiving. It plans to enroll about 30 participants.
What's involved
You will receive Padeliporfin intravenously, followed by a procedure where a fiber is placed in an artery for 10 minutes of light illumination. The study will evaluate your safety at Day 30.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be checked at Day 30 after the treatment.

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NCT05919238

Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Impact Biotech Ltd
~30 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Padeliporfin Vascular Targeted Photodynamic (VTP) therapy

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of endovascularly applied Padeliporfin VTP ablation
Measured over Day 30
+1 more outcome measured
Locally Advanced Unresectable Pancreatic Adenocarcinoma
2 sites across 1 states
California2
  • Nadine Abi-Jaoudeh, MD · PRINCIPAL_INVESTIGATOR · University of California, Irvine

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Eligibility criteria

Inclusion

Women of child-bearing potential (i.e., fertile, following menarche, and until becoming postmenopausal unless permanently sterile; permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) must test negative for pregnancy at the time of screening on the basis of a urine or serum pregnancy test.
Postmenopausal women are defined as those who have had an absence of menstruation for at least 2 years.
Female subjects of reproductive potential must agree to use two effective methods of birth control during the study and for 1 month after the last dose of study medication.
Male subjects must agree to use condoms during the study and for 90 days after the last dose within the 7 days before VTP treatment of study medication.
  • Safety of endovascularly applied Padeliporfin VTP ablationDay 30

    Safety of endovascularly applied Padeliporfin VTP ablation will be assessed using the CTCAE version 5.0. All adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) for being included in analyses.

  • Determination of the Maximum Tolerated Light Dose (MTD) and/or Recommended Phase 2 light dose (RP2D) in Part ADay 30

    MTD is defined as the dose level associated with \<33% of DLT-evaluable patients experiencing a DLT. If the MTD is reached, the RP2D will be defined as MTD. If the MTD is not reached, the RP2D will be selected based on integrated evaluation of safety and clinical benefit for all dose levels tested.