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A Safety Study of 212Pb-Pentixather Radioligand Therapy

NCT05557708 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-08

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Holden Comprehensive Cancer Center

    collaborator OTHER

  • Yusuf Menda

    lead OTHER

Principal Investigators

  • Yusuf Menda, MD · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-06-30
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05557708 on ClinicalTrials.gov