Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor: Impact Biotech Ltd
Study ID: NCT05918783
Phase: PHASE1
Status: Recruiting

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Conditions

Peripheral Lung Tumor

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Padeliporfin Vascular Targeted Photodynamic (VTP) therapy — COMBINATION_PRODUCT
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.

Study Details

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.

Key Dates

Start date: May 28, 2025
Status verified: Oct 2024
Primary completion: May 30, 2027
Completion: Dec 30, 2028

Study Design

Enrollment: 36 participants (estimated)
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Arms

Experimental: Part A
will be a monotherapy light dose escalation with single dose of Padeliporfin at light laser doses of 150, 250 and 400 mW/cm for 20 minutes. Part A will proceed with light dose escalation and will continue until the maximum tolerated light dose (MTD) and/or recommended phase 2 dose (RP2D) is defined.
Experimental: Part B
will be a dose expansion part at MTD/RP2D dose level identified in Part A to further assess the safety, tolerability, and treatment effect of the MTD and/ or RP2D

Primary Outcome Measure

Safety of robotic assisted bronchoscopic Padeliporfin VTP ablation [ Time Frame: Day 30 ]

Central Contacts

Eyal Morag, MD
+972542056619
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Johns Hopkins University School of Medicine	Baltimore	Maryland	21224	Lonny Yarmus

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By research site

Johns Hopkins University School of Medicine· Baltimore, MD