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Trial Title:
Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma
NCT ID:
NCT05919238
Condition:
Locally Advanced Unresectable Pancreatic Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Part B recruitment will be opened upon completion of Part A light dose escalation.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Padeliporfin Vascular Targeted Photodynamic (VTP) therapy
Description:
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
Arm group label:
Part A
Arm group label:
Part B
Other name:
Padeliporfin VTP
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
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 = 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jonathan Kessler, MD
Facility:
Name:
University of California Irvine
Address:
City:
Irvine
Zip:
92697
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nadine Abi-Jaoudeh, MD
Start date:
May 15, 2024
Completion date:
October 30, 2026
Lead sponsor:
Agency:
Impact Biotech Ltd
Agency class:
Industry
Source:
Impact Biotech Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05919238
