A Multicenter Open-label Phase 1/1b Study to Evaluate Safety, Feasibility and Early Treatment Effect of Padeliporfin VTP Using Robotic Assisted Bronchoscopy and Cone Beam CT Guidance in Patients With Peripheral Lung Cancer
Impact Biotech Ltd
Summary
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.
Description
A multicenter, open label, 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. Patients who are candidates for lung resection will be recruited as a diagnose and treat in the same anaesthesia, protocol; surgery will be performed at least 5 days and up to 21 days following the VTP procedure. Study intervention will consist of robotic assisted bronchoscopic Padeliporfin VTP lung ablation: vasc…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥18 2. Patients with primary lung lesions who are at high risk for primary lung cancer. 2.1.Biopsy with intraoperative confirmation of malignancy using on-site cytology will be used as final inclusion prior to study treatment. 3. All patients will be approved by a multi-disciplinary team (thoracic surgery, interventional pulmonology, medical oncology and radiation oncology) as appropriate for bronchoscopic VTP prior to surgical resection. 4. Tumor size targeted for VTP treatment ≤ 2 cm (Part A) and \<3cm (Part B), based on CT scan, including solid or semi-solid…
Interventions
- Combination ProductPadeliporfin Vascular Targeted Photodynamic (VTP) therapy
Bronchoscopy will be performed with robotic assisted approach using standard practices using general anaesthesia and placement of the optic fiber intratumorally followed by IV administration of Padeliporfin for 10 min and laser light illumination.
Location
- Johns Hopkins University School of MedicineBaltimore, Maryland