Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma

NCT05919238 | Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: CLIN2301 PNCM101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Locally Advanced Unresectable Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Safety of endovascularly applied Padeliporfin VTP ablation

  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.

  Day 30

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

  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.

  Day 30

Secondary Outcomes (3)

• Descriptive features of treatment response to ablation in tumor tissue based on pre- and post -VTP CT scans

  Day 2

• Tumor Response by CT scans

  Day 30

• Tumor Response by CT scans

  Day 60

Other Outcomes (1)

• Exploratory endpoints

  60 days

Study Arms (2)

Part A

EXPERIMENTAL

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.

Combination Product: Padeliporfin Vascular Targeted Photodynamic (VTP) therapy

Part B

EXPERIMENTAL

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

Combination Product: Padeliporfin Vascular Targeted Photodynamic (VTP) therapy

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

Also known as: Padeliporfin VTP

Part A; Part B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 18 years of age and older 2. Patient is 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. Patients have an 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 6. Patient with target artery solid tumor contact ˃180° for a total contact length up to 3cm, and with entire target artery internal diameter 5-10 mm. 7. All patients will be approved by a multi-disciplinary team (including medical oncologist, surgeon, interventional radiologist) as appropriate for endovascular VTP treatment. 8. Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors according to RECIST 1.1 9. ECOG performance status ≤ 1 10. Life expectancy at least 6 months 11. No evidence of metastatic disease by CT scan chest, abdomen and pelvis performed within 28 days prior to treatment 12. Adequate organ system function including:
• a. Absolute neutrophil count (ANC) ≥1500/mm3 without the use of hemopoietic growth factors within the 7 days before VTP treatment b. Absolute white blood cell count ≥3.0\*109/L c. Hemoglobin at least 10g/dL d. Platelet count ≥75,000/mm3 e. 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 whether medically indicated, is permitted. f. Creatinine clearance ≥60 mL/min using Cockcroft-Gault equation g. Amylase and lipase \<1.5xULN h. ALT/AST ≤2.5\*ULN and total bilirubin ≤2\*ULN (benign hereditary hyperbilirubinemias, e.g., Gilbert's syndrome, are permitted, those patients must have total bilirubin \<3 mg/dL).
• \. Patient may have received prior neoadjuvant systemic therapy (chemotherapy and/or immunotherapy) 14. Patient with no prior external beam radiation therapy to the pancreas 15. Patient with prior attempted surgical resection is permitted 16. No comorbidities which would preclude access to the target artery by endovascular catheterization 17. Male or nonpregnant and nonlactating female aged ≥18 years
• 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.

You may not qualify if:

• Metastatic (stage IV) disease
• SMA originated not from aorta
• Any anatomical variant or vascular abnormality that precludes safe placement of the balloon and device assembly in the target artery in the discretion of the principle investigator.
• Hemodynamically significant moderate to severe atherosclerotic flow limiting changes of target vessel wall
• Hemodynamically significant stenosis of the CA
• Previous radiotherapy treatment for pancreatic cancer
• Cystic component \>= 25% the total volume of the tumor
• Moderate to severe clinical ascites not controlled by medication detected by CT, ultrasound (US) or MRI;
• Known additional malignancy that is progressing and/or requires active treatment.
• Cardiac function: history of congestive heart failure or recent (within 6 months) myocardial infarction or ischemic event
• Unable to receive or previously intolerant of moderate and/or deep sedation
• 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
• Unwilling or unable to comply with study procedures and/or study visits
• Receipt of prior definitive resection for pancreatic cancer
• Pregnant and/or nursing

Sponsors & Collaborators

• Impact Biotech Ltd: lead

Study Sites (2)

City of Hope

Duarte, California, 91010, United States

RECRUITING

University of California Irvine

Irvine, California, 92697, United States

RECRUITING

MeSH Terms

Interventions

Therapeutics

Study Officials

• Nadine Abi-Jaoudeh, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eyal Morag, MD

CONTACT

+972 54 2056619; eyal.morag@impactbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part B recruitment will be opened upon completion of Part A light dose escalation.

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 26, 2023
• Study Start: May 15, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)