Padeliporfin VTP for Lung Cancer
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
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Robotic assisted bronchoscopic Padeliporfin VTP lung ablation with light dose escalation to determine MTD/RP2D
Surgery
Surgery performed 5-21 days following the VTP procedure to assess feasibility and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of treatment-related adverse events
Treatment Details
Interventions
- Padeliporfin VTP
Padeliporfin VTP is already approved in European Union for the following indications:
- 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
Steba Biotech S.A.
Lead Sponsor
Impact biotech Ltd.
Collaborator