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

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.12345

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.678910

Who Is on the Research Team?

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

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.
See 6 more

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?
2Treatment groups
Experimental Treatment
Group I: Part BExperimental Treatment1 Intervention
Group II: Part AExperimental Treatment1 Intervention

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

🇪🇺
Approved in European Union as Tookad for:

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+

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.
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.
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.
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]

Citations

Vascular targeted photochemotherapy using padoporfin ...Vascular targeted photochemotherapy (VTP) holds promise as a novel strategy of the focal treatment of localised prostate cancer (LPCa).
ImPact Biotech Announces New Data Presentations at ...ImPact Biotech Announces New Data Presentations at AUA 2025 Highlighting Safety and Efficacy of Padeliporfin VTP. Company to present updated ...
Phase 2b trial results of padeliporfin (WST11 or Tookad ...Conclusions: The positive results from this trial show that WST11-VTP is effective for PGA of intermediate-risk prostate cancer, with minimal toxicity or impact ...
Padeliporfin VTP Shows Promise for Low-Grade Upper ...Interim results reveal padeliporfin VTP therapy as a promising, safe treatment for low-grade upper tract urothelial cancer, preserving kidney function.
A Phase III Study of Padeliporfin Vascular Targeted ...In this study, researchers want to learn if padeliporfin VTP therapy is effective and safe for people with low-grade upper urothelial cancers.
Final Results of a Phase I Trial of WST-11 (TOOKAD ...The procedure led to a 50% complete response rate at 30 days and 68% complete response rate after a second VTP treatment. Overall, VTP with WST-11 has the ...
Padeliporfin VTP for Lung CancerWhile specific safety data for lung cancer is not available, its use in ... Soluble VTP is a safe option for minimally invasive prostate cancer therapy.
Padeliporfin - an overviewThe study concluded that TOOKAD® Soluble was a safe and effective treatment for low-risk, localized prostate cancer [35]. After 24 months, only 28% of the ...
Padeliporfin vascular-targeted photodynamic therapy ...Padeliporfin vascular-targeted photodynamic therapy is a safe, effective treatment for low-risk, localised prostate cancer. This treatment might ...
Padeliporfin: Uses, Interactions, Mechanism of ActionPadeliporfin is a vascular-acting photosensitizer used to treat low-risk prostate cancer in adults.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security