36 Participants Needed

Padeliporfin VTP for Lung Cancer

EM
Overseen ByEyal Morag, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Phase 1/1b, safety, feasibility, and light dose titration study followed by further study of therapeutic ablation effects. Patients with high risk of peripheral primary lung cancer, stage 1A1/1A2, for whom surgical treatment is planned, will be recruited. Surgery will be performed at 5-21 days following the VTP procedure. Study intervention: robotic assisted bronchoscopic Padeliporfin VTP lung ablation: vascular targeted photodynamic therapy using Padeliporfin photosensitizer.

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 data supports the effectiveness of the treatment Padeliporfin VTP for lung cancer?

Padeliporfin VTP has shown promise in treating localized prostate cancer and upper tract urothelial carcinoma by targeting blood vessels in tumors, which suggests it might be effective for other cancers like lung cancer. This treatment uses a special light-activated drug to destroy cancer cells, and its success in other cancers provides hope for its potential use in lung cancer.12345

Is Padeliporfin VTP safe for use in humans?

Padeliporfin VTP has been evaluated for safety in clinical trials for localized prostate cancer and upper tract urothelial carcinoma, showing it to be a minimally invasive treatment with a focus on safety and quality of life. While specific safety data for lung cancer is not available, its use in other conditions suggests it is generally safe in humans.12456

What makes the drug Padeliporfin VTP unique for treating lung cancer?

Padeliporfin VTP is unique because it uses a light-activated process called photodynamic therapy, which targets cancer cells with a special drug that becomes active when exposed to light, causing the cancer cells to die. This approach is different from traditional treatments like chemotherapy, which affect both cancerous and healthy cells.7891011

Research Team

Dr. Lonny Yarmus, DO - Baltimore, MD ...

Lonny Yarmus, DO

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

I am at high risk for lung cancer due to a primary lung lesion.
My cancer was confirmed malignant with a biopsy during surgery.
A team of lung cancer specialists has approved me for a specific lung procedure before surgery.
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Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Part BExperimental Treatment1 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 AExperimental Treatment1 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)

Find a Clinic Near You

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+

Findings from Research

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.
Vascular targeted photochemotherapy using padoporfin and padeliporfin as a method of the focal treatment of localised prostate cancer - clinician's insight.Bugaj, AM.[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.
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]
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.
Developments in Vascular-Targeted Photodynamic Therapy for Urologic Malignancies.Nogueira, L., Tracey, AT., Alvim, R., et al.[2021]

References

Vascular targeted photochemotherapy using padoporfin and padeliporfin as a method of the focal treatment of localised prostate cancer - clinician's insight. [2020]
Final Results of a Phase I Trial of WST-11 (TOOKAD Soluble) Vascular-targeted Photodynamic Therapy for Upper Tract Urothelial Carcinoma. [2023]
Developments in Vascular-Targeted Photodynamic Therapy for Urologic Malignancies. [2021]
TOOKAD(®) Soluble vascular-targeted photodynamic (VTP) therapy: determination of optimal treatment conditions and assessment of effects in patients with localised prostate cancer. [2014]
The Role of Photoactivated and Non-Photoactivated Verteporfin on Tumor. [2020]
Photophysical Characterization and in Vitro Phototoxicity Evaluation of 5,10,15,20-Tetra(quinolin-2-yl)porphyrin as a Potential Sensitizer for Photodynamic Therapy. [2020]
Pharmacokinetic and tumour-photosensitizing properties of the cationic porphyrin meso-tetra(4N-methylpyridyl)porphine. [2019]
Combined chemotherapeutic and photodynamic treatment on human bladder cells by hematoporphyrin-platinum(II) conjugates. [2019]
Lipophilic cationic porphyrins as photodynamic sensitisers-Synthesis and structure-activity relationships. [2014]
10.United Statespubmed.ncbi.nlm.nih.gov
Photosensitizing properties of palladium-tetraphenylporphycene on cultured tumour cells. [2006]
Necrotic cell death induced by photodynamic treatment of human lung adenocarcinoma A-549 cells with palladium(II)-tetraphenylporphycene. [2019]
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