Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
completion around
Principal Investigator
by Nadine Abi-Jaoudeh, MD

Description

Summary

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 superior mesenteric artery (SMA) in patients with stage III, locally advanced (LA) unresectable pancreatic ductal adenocarcinoma (PDAC). The investigators will evaluate safety and preliminary efficacy of Padeliporfin VTP administered endovascularly using light dose escalation.

Official Title

A Multicenter Open-label Phase 1 Trial to Evaluate Safety and Preliminary Efficacy of Endovascularly Applied Vascular Targeted Photodynamic Therapy (VTP) for Patients With Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma

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 superior mesenteric artery (SMA) in patients with stage III, locally advanced (LA) unresectable pancreatic ductal adenocarcinoma (PDAC) with SMA solid tumor encasement >180°. The investigators will evaluate safety and preliminary efficacy of Padeliporfin VTP administered endovascularly using light dose escalation.

Study Intervention: Patients enrolled in the study will undergo endovascular VTP, using Padeliporfin (WST-11) activated via endovascular fiber placement through the SMA, with intravenous administration of Padeliporfin at a fixed dose of 4 mg/kg of padeliporfin di-potassium, followed by total of 10 min illumination at 753 nm.

For light dose escalation (Part A), a 3+3 dose-escalation schema will be used. In a subsequent expansion phase (Part B), the optimal light dose as per light dose escalation, will be used in an additional cohort of patients to further evaluate preliminary efficacy.

Keywords

Locally Advanced Unresectable Pancreatic Adenocarcinoma, Adenocarcinoma, Padeliporfin Vascular Targeted Photodynamic (VTP) therapy

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Patients 18 years of age and older
  2. Capable of giving written informed consent
  3. Patients with a diagnosis of Stage III pancreatic ductal adenocarcinoma, cytologically or histologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria
  4. Patient has a unresectable tumor, evaluated as Stage III according to National Comprehensive Cancer Network (NCCN) guidelines resectability criteria, based on radiographic imaging or exploratory surgery as a locally advanced (LA) pancreatic ductal adenocarcinoma (PDAC)
  5. Patients with LA PDAC located in the head/uncinate process of the pancreas, with SMA encasement ˃180° for a total proximal SMA encasement length up to 3cm
  6. Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors according to RECIST 1.1
  7. ECOG performance status </= 1
  8. Life expectancy at least 3 months
  9. No evidence of metastatic disease by CT scan chest abdomen and pelvis performed within 14 days prior to treatment

    10. Adequate Hematological, biochemical, and organ (kidney, liver, cardiac) function 11. International normalized ratio (INR) <1.5 unless the patient is receiving

    anticoagulation therapy, in which case a therapeutic INR is acceptable. Anticoagulation therapy with low-molecular-weight heparin or warfarin, whether medically indicated, is permitted.

    12. May have received prior neoadjuvant systemic therapy 13. No prior external beam radiation therapy to the pancreas 14. No comorbidities which would preclude access to the superior mesenteric artery by

    intravascular catheterization

You CAN'T join if...

  1. Metastatic (stage IV) disease (including involvement of the colon, adrenals, or kidney, or radiographic evidence of peritoneal seeding or pulmonary metastases)
  2. SMA anatomical variants (SMA origin not from aorta)
  3. Previous radiotherapy treatment for pancreatic cancer
  4. Cystic component >= 25% the total volume of the tumor
  5. Ascites detected by CT, ultrasound (US) or MRI;
  6. Diagnosis of islet cell tumor, lymphoma, metastatic lesion, acinar cell (or other atypical pathologic malignancy)
  7. History of other malignancy requiring treatment in the past 2 years
  8. Unable to receive or previously intolerant of moderate and/or deep sedation
  9. Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, and participate in the study or that is likely to interfere with the interpretation of the results

    10. Pregnant and/or nursing 11. Active infection, with the exception of resolving cholangitis 12. Known hypersensitivity to iodine contrast 13. Receipt of concurrent investigational therapy or within 30 days of protocol initiation 14. Any other medical or psychiatric comorbidities, including decompensated heart failure,

    unstable angina or coronary artery disease or severe pulmonary disease, that, in the opinion of the study investigator, would make the patient a poor candidate for the study

    15. Systemic chemotherapy treatment within less than 30 days prior to planned VTP or/and

    for VEGF-targeted therapy within less than 2 months prior to planned VTP treatment

    16. Prohibited medication that could not be adjusted or discontinued prior to study

    treatment

    17. Patients with photosensitive skin diseases or porphyria

Locations

  • University of California Irvine
    Irvine California 92697 United States
  • City of Hope
    Duarte California 91010 United States

Lead Scientist at UC Irvine

  • Nadine Abi-Jaoudeh, MD
    Clinical Professor, Radiological Sciences, School of Medicine. Authored (or co-authored) 65 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Impact Biotech Ltd
ID
NCT05919238
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated