Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer

NCT05918783 | Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: CLIN2201 LCM101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Lung Tumor

Outcome Measures

Primary Outcomes (3)

• Safety of robotic assisted bronchoscopic Padeliporfin VTP ablation

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

  Day 30

• Feasibility of robotic assisted bronchoscopic Padeliporfin VTP treatment

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

  Day 1

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

  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.

  Day 14

Secondary Outcomes (2)

• Evaluation lung surgery feasibility

  Day 5-21

• Evaluation of the ablation area

  2 days post Padeliprofin VTP

Study Arms (2)

Part A

EXPERIMENTAL

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.

Combination Product: Padeliporfin Vascular Targeted Photodynamic (VTP) therapy

Part B

EXPERIMENTAL

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

Combination Product: Padeliporfin Vascular Targeted Photodynamic (VTP) therapy

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.

Also known as: Padeliporfin VTP

Part A; Part B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Patients with primary lung lesions who are at high risk for primary lung cancer.
• 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.
• Tumor size targeted for VTP treatment ≤ 2 cm (Part A) and \<3cm (Part B), based on CT scan, including solid or semi-solid tumors.
• EBUS mediastinal staging performed intraoperative prior to VTP treatment with rapid on-site evaluation negative for nodal involvement of malignancy.
• Tumor is ≥ 2cm from the central bronchial tree (distal 2 cm of the trachea, carina, and named major lobar bronchi up to their first bifurcation) (Timmerman, 2018).
• Lung lesion is not contiguous with and ≥ 1 cm from the pleura/fissures.
• Patient is eligible to undergo bronchoscopy under general anesthesia.
• Tumor is accessible for Padeliporfin VTP treatment via robotic bronchoscopy
• ECOG performance score 0-2
• Estimated life expectancy of ≥3 months
• Adequate organ system function
• Negative serum pregnancy test

You may not qualify if:

• Patient has a centrally located lung lesion, as defined by RTOG within 2 cm of the proximal bronchial tree, or within 2 cm of other major mediastinal structure (aorta, heart, trachea, pericardium, superior vena cava, pulmonary artery, esophagus, vertebra's body or spinal canal).
• Patient has a lung lesion located less than 1 cm from the pleura or fissure
• Patient has a lung cancer lesion \>2cm in diameter, for the expansion cohort lesion \>2-3 cm
• Patient has cytologic or histologic evidence of nodal disease
• Tumor invades major vessels
• Prior exposure to VTP or PDT treatments
• Pregnant or breastfeeding women
• Receiving any other investigational treatment
• Co-morbidities:
• Baseline hypoxia with O2 saturation \<92% on 2L NC or more of oxygen
• New York Heart Association (NYHA) stage III/IV heart failure
• Unstable coronary artery disease or MI within the last 6 months
• Uncontrollable clinically serious arrhythmia
• Decompensated/clinically worsening interstitial lung disease or obstructive lung disease.
• Unstable cerebrovascular or peripheral vascular disease

Sponsors & Collaborators

• Impact Biotech Ltd: lead

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Interventions

Therapeutics

Study Officials

• Lonny Yarmus, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eyal Morag, MD

CONTACT

+972542056619; eyal.morag@impactbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part B recruitment will be opened upon completion of Part A light dose escalation.

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: June 26, 2023
• Study Start: May 28, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: February 11, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)