Padeliporfin VTP for Pancreatic Cancer

Recruiting at 1 trial location

Overseen By Eyal Morag, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Impact Biotech Ltd

Must not be taking: VEGF-targeted therapy

Disqualifiers: Metastatic disease, SMA variants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and early effects of a new treatment called Padeliporfin VTP for individuals with a specific type of pancreatic cancer that cannot be surgically removed. The treatment uses light to target cancer cells through a process called photodynamic therapy, delivered directly to the area via a blood vessel. The trial will test different light doses to determine the safest and most effective one. Individuals with stage III pancreatic cancer, whose tumors are located in the head of the pancreas and cannot be surgically removed, might be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that certain prohibited medications need to be adjusted or discontinued before the study treatment. It's best to discuss your current medications with the study team to see if any changes are needed.

Is there any evidence suggesting that Padeliporfin VTP is likely to be safe for humans?

Research has shown that Padeliporfin VTP has promising safety results in various studies. It is already approved in Europe for treating prostate cancer, indicating a level of safety. In studies for low-grade upper tract urothelial carcinoma, researchers are further testing its safety and effectiveness.

Padeliporfin VTP uses light to activate a drug that targets cancer cells. This method resembles other treatments that have succeeded in lab tests for pancreatic cancer. Overall, the data suggests that Padeliporfin VTP is generally well-tolerated, but specific safety details for pancreatic cancer remain under study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for pancreatic cancer, which typically involve chemotherapy, radiation, or surgery, Padeliporfin VTP offers a novel approach by using a light-activated drug. This treatment works by delivering Padeliporfin to the tumor and then activating it with a specific laser light, causing targeted destruction of cancer cells with minimal damage to surrounding tissue. Researchers are excited about this therapy because it has the potential to be less invasive and more precise, reducing side effects and improving patient quality of life compared to traditional methods.

What evidence suggests that Padeliporfin VTP might be an effective treatment for pancreatic cancer?

Research has shown that Padeliporfin VTP yields promising results for treating certain cancers. In a previous study, 94% of patients responded to this treatment, with half experiencing complete tumor disappearance after just one session. Padeliporfin targets the blood vessels feeding the tumor, using a special light-activated drug to block them, potentially starving the tumor. Although data for pancreatic cancer is limited, this method appears promising for treating solid tumors like those in the pancreas. The ongoing trial explores its potential for patients with advanced pancreatic cancer that cannot be surgically removed. Participants in this trial will receive Padeliporfin VTP in two parts: Part A involves a monotherapy light dose escalation to determine the maximum tolerated dose, and Part B will further assess safety and treatment effect at the identified dose level. ^{1 2 5 6 7}

Who Is on the Research Team?

Nadine Abi-Jaoudeh, MD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Stage III pancreatic ductal adenocarcinoma that can't be surgically removed. Participants must have a life expectancy of at least 3 months, good performance status (able to carry out daily activities), and no metastatic disease. They should also have adequate blood counts and organ function.

Inclusion Criteria

My blood clotting time is normal or managed with medication.

I may have had treatment before surgery to shrink my tumor.

Capable of giving written informed consent

Exclusion Criteria

I have been treated for another cancer within the last 2 years.

I haven't had chemotherapy or VEGF-targeted therapy in the last 30 days.

Pregnant and/or nursing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Part A

Light dose escalation with single dose of Padeliporfin at light laser doses of 200, 400, and 600 mW/cm for 10 minutes

4 weeks

Multiple visits for dose escalation

Treatment - Part B

Dose expansion at MTD/RP2D dose level to further assess safety, tolerability, and treatment effect

4 weeks

Multiple visits for treatment assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Follow-up visits at Day 30 and Day 60

What Are the Treatments Tested in This Trial?

Interventions

• Padeliporfin VTP

Trial Overview The trial tests Padeliporfin VTP therapy, which involves injecting a drug into the bloodstream and activating it with light inside the pancreas through an artery. The study aims to find safe doses and see how well it works against advanced pancreatic cancer.

How Is the Trial Designed?

Group I: Part B Experimental Treatment 1 Intervention

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

Group II: Part A Experimental Treatment 1 Intervention

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.

Padeliporfin VTP is already approved in European Union for the following indications:

Approved in European Union as Tookad for:

• Low-risk prostate cancer
• Upper tract urothelial carcinoma (UTUC)

Who Is Running the Clinical Trial?

Impact Biotech Ltd

Lead Sponsor

Trials

2

Recruited

70+

Steba Biotech S.A.

Lead Sponsor

Trials

17

Recruited

1,300+

Impact biotech Ltd.

Collaborator

Trials

2

Recruited

70+

Published Research Related to This Trial

Vascular targeted photochemotherapy (VTP) using padoporfin and padeliporfin is a promising, minimally invasive treatment for localized prostate cancer, allowing for outpatient procedures.

Clinical trials indicate that VTP is effective for focal treatment of prostate cancer, and future developments aim to standardize this method with real-time feedback protocols and cost-effectiveness analyses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular targeted photochemotherapy using padoporfin and padeliporfin as a method of the focal treatment of localised prostate cancer - clinician's insight. Bugaj, AM.[2020]

Five new phosphorus(V) porphyrins were developed, showing good water-solubility and promising photophysical properties for use in phototherapy.

Two of these compounds demonstrated strong photocytotoxic effects against esophageal cancer cell lines, with IC50 values comparable to the established treatment mTHPC, indicating their potential as effective agents in photodynamic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lead structures for applications in photodynamic therapy. 5. Synthesis and biological evaluation of water soluble phosphorus(V) 5,10,15,20-tetraalkylporphyrins for PDT. Ryan, AA., Ebrahim, MM., Petitdemange, R., et al.[2014]

Photodynamic therapy (PDT) using verteporfin was found to be more effective than sodium porfimer in inducing cell death in pancreatic cancer cells, requiring 60 times lower concentration for similar effects.

The efficacy of PDT was shown to be independent of the inflammatory microenvironment created by activated stromal cells, indicating that PDT could be a reliable treatment option even in the presence of tumor-associated inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Verteporfin- and sodium porfimer-mediated photodynamic therapy enhances pancreatic cancer cell death without activating stromal cells in the microenvironment. Lu, J., Roy, B., Anderson, M., et al.[2020]

Deuteporfin, a novel photosensitizer, shows promise as a tracer agent for detecting lymphatic metastases in pancreatic cancer, demonstrating selective enrichment in cancerous tissues compared to normal tissues in a xenograft model.

The study found that deuteporfin can be administered intravenously, allowing for rapid accumulation in pancreatic and lymphatic tissues, making it a potentially effective tool for surgical applications in pancreatic cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of the role of the photosensitizer, deuteporfin, in the detection of lymphatic metastases in a pancreatic cancer xenograft model. Yu, X., Li, H., Fu, D., et al.[2020]

In a Phase I trial involving 19 patients with upper tract urothelial carcinoma, vascular-targeted photodynamic therapy using the agent WST-11 showed a high initial treatment response rate of 94%, with 50% achieving complete response and 44% partial response within 30 days.

The therapy demonstrated an acceptable safety profile, with transient side effects like flank pain and hematuria, and no significant long-term complications such as ureteral strictures, indicating its potential as a kidney-sparing treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Final Results of a Phase I Trial of WST-11 (TOOKAD Soluble) Vascular-targeted Photodynamic Therapy for Upper Tract Urothelial Carcinoma. Yip, W., Sjoberg, DD., Nogueira, LM., et al.[2023]

EUS-guided verteporfin photodynamic therapy (PDT) was found to be feasible and safe for ablating locally advanced pancreatic cancer (LAPC), with no adverse events reported during or after the procedure in a pilot study of 8 patients.

The treatment resulted in tumor necrosis visible within 48 hours in 5 out of 8 patients, indicating its potential effectiveness as a minimally invasive option for patients with nonresectable LAPC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EUS-guided verteporfin photodynamic therapy for pancreatic cancer. Hanada, Y., Pereira, SP., Pogue, B., et al.[2023]

Verteporfin, a novel photosensitizer, demonstrated a safety profile similar to meso-tetrahydroxyphenylchlorin (mTHPC) in treating pancreatic cancer, with safe light doses identified that produced necrotic lesions without significant damage to surrounding tissues.

The drug has a short elimination half-life of 4-5 hours and a shorter drug-light interval, making it a promising candidate for Phase I clinical studies in pancreatic cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy using verteporfin photosensitization in the pancreas and surrounding tissues in the Syrian golden hamster. Ayaru, L., Wittmann, J., Macrobert, AJ., et al.[2022]

Photodynamic therapy (PDT) is gaining renewed interest in treating urological cancers due to advancements in understanding cancer biology and the development of better photosensitizers.

Vascular-targeted PDT (VTP) using padeliporfin has shown tumor-specific effectiveness, making it a promising option for managing urologic malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developments in Vascular-Targeted Photodynamic Therapy for Urologic Malignancies. Nogueira, L., Tracey, AT., Alvim, R., et al.[2021]

Citations

1. impactbiotech.com impactbiotech.com/impact-biotech-announces-new-data-presentations-at-aua-2025-highlighting-safety-and-efficacy-of-padeliporfin-vtp/

ImPact Biotech Announces New Data Presentations at ... Padelipor n VTP is currently being evaluated in a pivotal Phase 3 study in low-grade upper tract urothelial carcinoma (UTUC) with earlier stage ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05919238

Study Details | NCT05919238 | Padeliporfin VTP Treatment ... This is a prospective, multicenter, non-randomized, open label light dose escalation phase I trial to evaluate the safety and preliminary efficacy of ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-08520

Padeliporfin VTP Treatment for Unresectable Pancreatic ... This is a prospective, multicenter, non-randomized, open label light dose escalation phase I trial to evaluate the safety and preliminary efficacy of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10265489/

Final Results of a Phase I Trial of WST-11 (TOOKAD ... In evaluating efficacy, VTP demonstrated tumor response in the majority (94%) of patients, with CR seen in half of patients after one treatment. Complete ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT451796

Phase 1 study to evaluate safety and preliminary efficacy of ... Phase 1 study to evaluate safety and preliminary efficacy of padeliporfin vascular targeted photodynamic therapy (VTP) in patients with locally advanced (LA) ...

6. withpower.com withpower.com/trial/padeliporfin-vtp-for-pancreatic-cancer-b02fd

Padeliporfin VTP for Pancreatic Cancer Research shows that similar treatments using photosensitizers like verteporfin have been effective in killing pancreatic cancer cells in laboratory settings.

7. sciencedirect.com sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/padeliporfin

Padeliporfin - an overview Padeliporfin di-potassium, developed by Steba Biotech Sa, was approved by the EMA to treat prostatic cancer on November 10, 2017, and is sold under the brand ...