A Safety Study of 212Pb-Pentixather Radioligand Therapy

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Yusuf Menda
Study ID
NCT05557708
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jul 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 212-Lead Pentixather
    Single intravenous infusion of Pentixather radiolabeled with Lead-212. Administered activity to participant is calculated from bone marrow and renal radiation constraints. Treatment is administered in 2 cycles with 6 weeks between the cycles.

Primary Outcome Measure

Determine the recommended phase 2 dose of 212-Lead Pentixather [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Health CareIowa CityIowa52242
Yusuf Menda, MD
[email protected]
319-356-3214
Kristin West, RN, BSN
[email protected]
Yusuf Menda, MD (PRINCIPAL_INVESTIGATOR)
Stephen Graves, PhD (SUB_INVESTIGATOR)
Joseph Dillon, MD (SUB_INVESTIGATOR)
David Bushnell, MD (SUB_INVESTIGATOR)
Michael Graham, MD, Ph.D. (SUB_INVESTIGATOR)

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By research site
University of Iowa Health Care· Iowa City, IA

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