Padeliporfin VTP for Peripheral Lung Cancer

This study is testing a new treatment called Padeliporfin Vascular Targeted Photodynamic (VTP) therapy for people with peripheral lung tumors. This therapy uses a robotic-assisted bronchoscopy (a procedure where a thin tube is inserted into the airways) to deliver Padeliporfin, a special drug, directly to the tumor. Then, a laser light is used to activate the drug. The main goals of this study are to check the safety and how well this treatment can be performed. Researchers also want to find the best light dose to use. You might be able to join if you are 18 or older and have a primary lung lesion with a high risk of being lung cancer, and surgery is planned.

Study design
This is a Phase 1/1b, open-label study designed to assess safety and feasibility, and to find the right light dose. It plans to enroll 36 participants.
What's involved
You would undergo a robotic-assisted bronchoscopy with Padeliporfin VTP treatment under general anesthesia. Surgery will be performed 5 to 21 days after the VTP procedure.
Compensation
Not stated in the trial record.
Follow-up
The study will measure safety at Day 30 and evaluate the maximum tolerated light dose by Day 14 after treatment.

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NCT05918783

Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Impact Biotech Ltd
~36 participants
Updated 2025-02-11 on ClinicalTrials.gov
What's tested:Padeliporfin Vascular Targeted Photodynamic (VTP) therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of robotic assisted bronchoscopic Padeliporfin VTP ablation
Measured over Day 30
+2 more outcomes measured
Peripheral Lung Tumor
1 sites across 1 states
Maryland1
  • Lonny Yarmus, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

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  • Safety of robotic assisted bronchoscopic Padeliporfin VTP ablationDay 30

    Incidence of treatment-related adverse events as assessed by CTCAE v5.0

  • Feasibility of robotic assisted bronchoscopic Padeliporfin VTP treatmentDay 1

    Feasibility of robotic bronchoscopic light fiber delivery into the target lesion as confirmed by cone beam CT and complete VTP treatment

  • Evaluate Maximum Tolerated light Dose and/or RP2D of Padeliporfin VTP ablationDay 14

    Evaluate Maximum Tolerated light Dose and/or RP2D of robotic assisted bronchoscopic Padeliporfin VTP ablation (a vascular targeted photodynamic therapy with Padeliporfin of patients with peripheral stage 1A1/1A2) primary non-small cell lung cancers.