Actively Recruiting
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
Led by Impact Biotech Ltd · Updated on 2025-02-11
36
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and early treatment effects of Padeliporfin vascular targeted photodynamic (VTP) therapy using a robotic assisted bronchoscopy approach in patients with high-risk peripheral primary lung cancer, stage 1A1/1A2, who are planned for surgical treatment. This phase 1/1b, open-label, multicenter study includes a light dose titration phase followed by further study of therapeutic ablation effects, aiming to define the maximum tolerated light dose and recommended phase 2 dose. The study intervention involves robotic assisted bronchoscopic lung ablation with Padeliporfin, a photosensitizer administered intravenously for 10 minutes, followed by laser light illumination through an optic fiber placed inside the tumor during bronchoscopy under general anesthesia. The trial has two parts: Part A is a light dose escalation with single doses at 150, 250, and 400 mW/cm for 20 minutes to find the maximum tolerated dose, and Part B is a dose expansion at this identified dose to further assess safety, tolerability, and treatment effect. Surgery to remove the tumor is performed 5 to 21 days after the VTP procedure. Participants will undergo pre-treatment evaluations including CT scans and mediastinal staging to confirm eligibility. During the study, researchers will assess the safety and feasibility of the robotic Padeliporfin VTP treatment, evaluate the maximum tolerated dose by day 14, and monitor surgical feasibility between days 5 and 21. They will also analyze the ablation area two days after treatment. Participants are monitored for adverse events and treatment response throughout the study, which continues up to the surgery and follow-up evaluations.
CONDITIONS
Brief Title
Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patients with primary lung lesions considered high risk for lung cancer
- Biopsy with intraoperative confirmation of malignancy prior to treatment
- Approval by a multi-disciplinary team for bronchoscopic VTP before surgery
- Tumor size 2 cm or smaller in Part A, less than 3 cm in Part B by CT scan
- Negative mediastinal nodal involvement confirmed by EBUS staging
- Tumor located at least 2 cm from central bronchial tree
- Lung lesion at least 1 cm away from pleura or fissures
- Eligible for bronchoscopy under general anesthesia
- Tumor accessible via robotic bronchoscopy
- ECOG performance status 0-2
- Estimated life expectancy at least 3 months
- Adequate organ function
- Negative serum pregnancy test
You will not qualify if you...
- Centrally located lung lesion within 2 cm of proximal bronchial tree or major mediastinal structures
- Lung lesion less than 1 cm from pleura or fissure
- Lung cancer lesion larger than 2 cm (or larger than 3 cm in expansion cohort)
- Evidence of nodal disease by cytology or histology
- Tumor invading major blood vessels
- Prior vascular targeted photodynamic or photodynamic therapy
- Pregnant or breastfeeding women
- Receiving other investigational treatments
- Baseline hypoxia requiring 2L oxygen or more with saturation below 92%
- NYHA class III or IV heart failure
- Recent unstable coronary artery disease or heart attack within 6 months
- Serious arrhythmias uncontrolled clinically
- Worsening interstitial or obstructive lung disease
- Unstable cerebrovascular or peripheral vascular disease
- Cannot stop anticoagulation or anti-platelet therapy around procedure
- Active infection requiring antibiotics
- Any acute or chronic condition making bronchoscopy unsafe
- Medical or psychiatric condition precluding safe treatment or compliance
- Severe pulmonary hypertension (mean arterial pressure 50 mmHg or more)
- Active cancer requiring further therapy
- Major surgery within last 4 weeks
- Porphyria or hypersensitivity to padeliporfin or related compounds or excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment day
Participants undergo robotic assisted bronchoscopic Padeliporfin VTP lung ablation under general anesthesia, where an optic fiber is placed intratumorally followed by intravenous administration of Padeliporfin and laser light illumination.
1 treatment visit (in-person)
Duration - 5 to 21 days
Participants will have lung resection surgery performed between 5 and 21 days after the Padeliporfin VTP treatment as part of the protocol.
1 surgery visit (in-person)
Duration - Up to 30 days post-treatment
Participants are monitored for safety, feasibility, and treatment effects including evaluation of the ablation area and lung surgery feasibility.
Approximately 3 visits (including assessments at Day 2, Day 14, and Day 30)
Trial Site Locations
Total: 1 location
1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
E
Eyal Morag, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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