NCT05557708

A Safety Study of 212Pb-Pentixather Radioligand Therapy

Biodistribution of 68Ga Pentixafor in Patients With Small Cell Lung Carcinoma (SCLC)

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Yusuf Menda · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human clinical trial evaluating the safety of an alpha-radiation treatment (Lead-212 labelled Pentixather) in patients who have been diagnosed with, and previously treated, for atypical carcinoid lesions of the lung.

Detailed description

This is a study to determine what dose is acceptably safe for further testing. In this study, participants are asked to: * undergo SPECT/CT imaging with Lead-203 Pentixather (a radiotracer) to ensure the tumor lesions have the needed receptors * undergo serial blood sampling for during and after the SPECT/CT scan for radiation and dosimetry calculations (to determine how much of the Lead-212 Pentixather to administer) * receive up to 2 infusions of arginine \& lysine as a kidney protectant * receive up to 2 infusions of Lead-212 Pentixather, 6 weeks between each infusion * undergo imaging at 3 months post treatment to determine disease response

Conditions

• Carcinoid Tumor Lung
• Neuroendocrine Tumor of the Lung
• Carcinoma, Small-Cell Lung

Interventions

Type	Name	Description
DRUG	212-Lead Pentixather	Pentixather radiolabeled with 212-lead to target malignant cells with the CXCR4 ligand.
DIAGNOSTIC_TEST	203-Lead Pentixather SPECT/CT	Pentixather radiolabeled with 203-Lead to identify the CXCR4 ligand on the malignant lesions for dosimetric analysis and treatment planning.

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-06-30
• Completion: 2030-06-30
• First posted: 2022-09-28
• Last updated: 2025-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study