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

CLIN2301 PNCM101

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.

2024-04-30

2025-04-30

2026-10-30

Not yet recruiting

Early phase I

30

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 \</= 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 Exclusion Criteria: 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Part B recruitment will be opened upon completion of Part A light dose escalation.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-03-05