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Not yet recruitingNCT05557708Updated Jul 8, 2025

A Safety Study of 212Pb-Pentixather Radioligand Therapy

An Early Phase 1 interventional study of 212-Lead Pentixather and 203-Lead Pentixather SPECT/CT in Carcinoid Tumor Lung, Neuroendocrine Tumor of the Lung and Carcinoma, Small-Cell Lung, sponsored by Yusuf Menda. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by Yusuf Menda · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

Read the 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
02

Conditions studied

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

Keywords

  • radioligand therapy
  • pentixather
  • Lead 203
  • Lead 212
  • alpha therapy
  • dosimetry
03

In context

Small Cell Lung Carcinoma

1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 340 are open to participants now.

This study's planned enrollment of 20 is below the median of 56 across 1,030 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Yusuf Menda is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ability to provide independent consent
  • adequate bone marrow function (platelet count ≥ 100,000; hemoglobin of ≥ 10 g/dL; neutrophil count ≥ 1,500 cells/mm3)
  • adequate kidney function (creatinine clearance of ≥ 50 mL/min using the Cockcroft-Gault equation
  • adequate liver function (serum bilirubin ≤ 3x the upper limit of normal, AST ≤ 5x the upper limit of normal, and ALT ≤ 5x the upper limit of normal)
  • failed initial therapy or declined further therapy known to confer benefit
  • have at least one lesion ≥ 2 cm that is positive for CXCR4 as demonstrated by Lead-203 Pentixather SPECT/CT

Exclusion criteria

Exclusion Criteria:

  • major surgery within 4 weeks of consent
  • antoher investigational agent within 4 weeks of consent
  • uncontrolled illness including, but not limited to, ongoing or active infection that would necessitate a delay in therapy or cause a hospital admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hepatic cirrhosis or severe impairment, or psychiatric illness/social situations that would limit compliance with study requirements.
  • prior solid organ transplant
  • cytotoxic or antineoplastic therapy within 21 days of consent (42 days for nitrosoureas)
  • antibody therapy within the 21 days of consent
  • allogenic bone marrow or stem cell transplant, or any stem cell infusion, within 84 days of consent
  • pregnancy
  • breastfeeding
  • refusal to comply with birth control requirements during study
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study 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.

    Drug: 212-Lead Pentixather · Diagnostic Test: 203-Lead Pentixather SPECT/CT

Interventions

  • Drug212-Lead Pentixather

    Pentixather radiolabeled with 212-lead to target malignant cells with the CXCR4 ligand.

  • Diagnostic test203-Lead Pentixather SPECT/CT

    Pentixather radiolabeled with 203-Lead to identify the CXCR4 ligand on the malignant lesions for dosimetric analysis and treatment planning.

06

What researchers measure

Primary outcomes

  1. Determine the recommended phase 2 dose of 212-Lead Pentixather

    The recommended phase 2 dose is based on the number of dose limiting toxicities observed post-treatment.

    Time frame: 3 months

Secondary outcomes

  1. Determine the targeting of atypical pulmonary neuroendocrine tumor and/or neuroendocrine carcinoma lesions with 203-Lead Pentixather SPECT/CT

    The number of lesions identified with 203-Lead Pentixather SPECT/CT will compared to FDG PET/CT and diagnostic CT scans at baseline.

    Time frame: baseline

  2. Determine tumor response

    Tumor response will be assessed using the Response Evaluation Criteria in Solid Tumours (RECIST, v 1.1).

    Time frame: 3 months

07

Study locations

1 site
  • University of Iowa Health Care
    Iowa City, Iowa 52242, United States
    • Yusuf Menda, MD · Contact · yusuf-menda@uiowa.edu · 319-356-3214
    • Kristin West, RN, BSN · Contact · kristin-gaimari-varner@uiowa.edu
    • 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
08

References and documents

Publications

  • Schottelius M, Osl T, Poschenrieder A, Hoffmann F, Beykan S, Hanscheid H, Schirbel A, Buck AK, Kropf S, Schwaiger M, Keller U, Lassmann M, Wester HJ. [177Lu]pentixather: Comprehensive Preclinical Characterization of a First CXCR4-directed Endoradiotherapeutic Agent. Theranostics. 2017 Jun 11;7(9):2350-2362. doi: 10.7150/thno.19119. eCollection 2017. PubMed 28744319 ↗
  • Buck AK, Serfling SE, Lindner T, Hanscheid H, Schirbel A, Hahner S, Fassnacht M, Einsele H, Werner RA. CXCR4-targeted theranostics in oncology. Eur J Nucl Med Mol Imaging. 2022 Oct;49(12):4133-4144. doi: 10.1007/s00259-022-05849-y. Epub 2022 Jun 8. PubMed 35674738 ↗
  • Serfling SE, Lapa C, Dreher N, Hartrampf PE, Rowe SP, Higuchi T, Schirbel A, Weich A, Hahner S, Fassnacht M, Buck AK, Werner RA. Impact of Tumor Burden on Normal Organ Distribution in Patients Imaged with CXCR4-Targeted [68Ga]Ga-PentixaFor PET/CT. Mol Imaging Biol. 2022 Aug;24(4):659-665. doi: 10.1007/s11307-022-01717-1. Epub 2022 Mar 21. PubMed 35312939 ↗

Individual participant data

Plan to share: Yes — Data are obtained from protected health information. Only data from study participants who consented to data sharing will be shared. Data type: * patient demographics (age at consent, self-identified race ethnicity and gender, insurance status) * tumor response (RECIST measures, imaging DICOM) * adverse event logs indicating CTCAEv5 term and severity on a per-subject basis * dosimetric analysis of 203-Lead Pentixather scans * dose limiting toxicities: type and incidence * diagnostic analysis of 203-Lead Pentixather and FDG PET/CT (or CT) scans

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05557708
Lead sponsor
Yusuf Menda
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI), Holden Comprehensive Cancer Center
Responsible party
Yusuf Menda (Professor and Director, Nuclear Medicine, University of Iowa) — Sponsor-investigator
First posted
Sep 28, 2022
Start date
Jul 1, 2026 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Jul 8, 2025

Study contacts

Yusuf Menda, MD
Contact
yusuf-menda@uiowa.edu
319-356-3214
Kellie Bodeker, Ph.D.
Contact
kellie-bodeker@uiowa.edu
319-384-9425
Yusuf Menda, MD
principal investigator · University of Iowa

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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