Padeliporfin VTP for Lung Cancer

Overseen By Eyal Morag, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Impact Biotech Ltd

Must not be taking: Anticoagulants, Antiplatelets, Antibiotics, others

Disqualifiers: Pregnancy, Heart failure, Hypoxia, 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: 1

Duration: 1 day

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Padeliporfin VTP for individuals with early-stage lung cancer who plan to undergo surgery. The study aims to determine the safety and effectiveness of this treatment, which uses light to target and destroy cancer cells in the lungs. Participants should have a small lung tumor (less than 3 cm) at high risk for cancer, but not located too close to the center of the chest. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be able to stop anticoagulation or anti-platelet therapy around the time of the procedure.

What prior data suggests that this robotic assisted bronchoscopic Padeliporfin VTP lung ablation is safe for patients with lung cancer?

Research has shown that Padeliporfin VTP, the treatment used in this trial for lung cancer, is safe in other applications. It has proven safe and effective for treating low-risk prostate cancer, with most patients tolerating it well and no major safety issues reported.

While specific safety data for lung cancer is not yet available, its success in prostate cancer suggests it might be well-tolerated. This trial is in its early stages, focusing on identifying the safest dose. Researchers closely monitor patient responses to ensure safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Unlike the standard treatments for lung cancer, which typically include surgery, chemotherapy, and radiation therapy, Padeliporfin VTP offers a novel approach by using a light-activated drug. This treatment involves administering Padeliporfin, which is activated by a specific laser light to target cancer cells directly. Researchers are excited because this method has the potential to minimize damage to surrounding healthy tissues and reduce side effects, offering a more precise and potentially less invasive treatment option for lung cancer patients.

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

Studies have shown that Padeliporfin VTP, a type of light-based therapy, effectively treats certain cancers. For instance, it has successfully managed prostate cancer and low-grade upper tract urothelial cancer. This treatment uses light to activate a drug called Padeliporfin, which targets and destroys cancer cells. Previous results demonstrated that it can reduce cancer with minimal side effects. In this trial, participants will receive Padeliporfin VTP to assess its safety and effectiveness for lung cancer. Although less information exists specifically for lung cancer, promising results in other cancers suggest it might be effective. ^{6 7 8 9 10}

Who Is on the Research Team?

Lonny Yarmus, DO

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults with early-stage peripheral lung cancer, who are high-risk surgical candidates. Eligible patients must have a tumor ≤3cm based on CT scans and confirmed malignancy via biopsy. The tumor should be accessible by robotic bronchoscopy, not too close to the central airways or pleura, and without nodal involvement of cancer.

Inclusion Criteria

My lung tumor is at least 1 cm away from the lung's outer layer.

I am at high risk for lung cancer due to a primary lung lesion.

My cancer was confirmed malignant with a biopsy during surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Robotic assisted bronchoscopic Padeliporfin VTP lung ablation with light dose escalation to determine MTD/RP2D

1 day

1 visit (in-person)

Surgery

Surgery performed 5-21 days following the VTP procedure to assess feasibility and safety

5-21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of treatment-related adverse events

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Padeliporfin VTP

Trial Overview

The study tests Padeliporfin Vascular Targeted Photodynamic (VTP) therapy using robotic-assisted bronchoscopy in patients with peripheral lung tumors. It's a Phase 1/1b trial focusing on safety and optimal light dose before surgery scheduled within 5-21 days post-VTP.

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 150, 250 and 400 mW/cm for 20 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

Palladium(II)-tetraphenylporphycene (PdTPPo) showed no dark toxicity in human lung adenocarcinoma A-549 cells at low concentrations, but induced dose-dependent necrotic cell death when combined with red light irradiation.

The study found that the mechanism of cell death in A-549 cells was primarily necrosis rather than apoptosis, highlighting the importance of cell type in determining the response to photodynamic therapy and indicating that cytoskeletal components are key targets in this process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Necrotic cell death induced by photodynamic treatment of human lung adenocarcinoma A-549 cells with palladium(II)-tetraphenylporphycene. Cañete, M., Ortega, C., Gavaldá, A., et al.[2019]

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]

In a study of 86 men with localized prostate cancer, treatment with 4 mg/kg TOOKAD(®) Soluble and 200 J/cm light resulted in 83% of patients having negative biopsy results for cancer at 6 months, indicating high efficacy for this treatment regimen.

The treatment was well tolerated, with most adverse events being mild or moderate, and no serious complications leading to discontinuation, suggesting that TOOKAD(®) Soluble VTP is a safe option for minimally invasive prostate cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TOOKAD(®) Soluble vascular-targeted photodynamic (VTP) therapy: determination of optimal treatment conditions and assessment of effects in patients with localised prostate cancer. Azzouzi, AR., Barret, E., Moore, CM., et al.[2014]

The cationic porphyrin T4MPyP demonstrated strong tumor localization in Balb/c mice with fibrosarcoma, achieving a concentration of approximately 1.2 ng/mg in tumors 24 hours post-administration, while levels in normal tissues were significantly lower.

Photodynamic therapy (PDT) using T4MPyP resulted in a temporary delay in tumor growth when irradiated, indicating its potential effectiveness as a treatment option in photodynamic therapy for cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and tumour-photosensitizing properties of the cationic porphyrin meso-tetra(4N-methylpyridyl)porphine. Villanueva, A., Jori, G.[2019]

The study identified a promising water-soluble porphyrin-platinum complex that combines the effects of cisplatin and photodynamic therapy, showing enhanced cytotoxicity against bladder cancer cells compared to traditional treatments.

This compound demonstrated a synergistic effect, meaning it worked better together than the individual drugs alone, suggesting a new potential strategy for cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined chemotherapeutic and photodynamic treatment on human bladder cells by hematoporphyrin-platinum(II) conjugates. Lottner, C., Knuechel, R., Bernhardt, G., et al.[2019]

The study presents a new method for synthesizing various lipophilic cationic porphyrins that contain phosphorus and nitrogen, which could be important for developing new treatments.

In vitro tests showed that these compounds have varying levels of photodynamic activity against human colorectal adenocarcinoma cells (HT-29), indicating that the chemical structure significantly influences their effectiveness in targeting cancer cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lipophilic cationic porphyrins as photodynamic sensitisers-Synthesis and structure-activity relationships. Hudson, R., Savoie, H., Boyle, RW.[2014]

The study found that palladium(II)-tetraphenylporphycene (PdTPP(0)) effectively kills HeLa cancer cells when activated by red light, showing no toxicity in the dark, which suggests a safe application for photodynamic therapy.

PdTPP(0) demonstrated superior photokilling properties compared to its predecessor, tetraphenylporphycene (TPP(0)), indicating its potential as a more effective sensitizer for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photosensitizing properties of palladium-tetraphenylporphycene on cultured tumour cells. Cañete, M., Ortiz, A., Juarranz, A., et al.[2006]

The study evaluated 5,10,15,20-tetra(quinolin-2-yl)porphyrin (2-TQP) as a potential photosensitizer for photodynamic therapy (PDT), finding it to have a high quantum yield of singlet oxygen generation (Φ∆ 0.62), which is crucial for effectively destroying cancer cells.

2-TQP demonstrated significant in vitro phototoxicity against HT29 colorectal adenocarcinoma cells without causing dark toxicity, indicating its potential as a safe and effective PDT agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photophysical Characterization and in Vitro Phototoxicity Evaluation of 5,10,15,20-Tetra(quinolin-2-yl)porphyrin as a Potential Sensitizer for Photodynamic Therapy. Costa, LD., e Silva, Jde A., Fonseca, SM., et al.[2020]

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]

Verteporfin (VP), traditionally used for treating age-related macular degeneration through photodynamic therapy, has shown significant anti-tumor effects by inhibiting the pro-tumorigenic factor YAP, which is involved in various cancers.

VP can exert its anti-cancer effects both with and without light activation, making it a promising candidate for repositioning as an anti-cancer chemotherapeutic and adjuvant drug, due to its ability to induce mitochondrial damage and increase reactive oxygen species production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Photoactivated and Non-Photoactivated Verteporfin on Tumor. Wei, C., Li, X.[2020]

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]

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Padeliporfin is a vascular-acting photosensitizer used to treat low-risk prostate cancer in adults.