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Not Yet RecruitingEarly Phase 1NCT05557708
Official study title

A Safety Study of 212Pb-Pentixather Radioligand Therapy

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studied212-Lead Pentixather and 203-Lead Pentixather SPECT/CT

The study team can explain what participation involves.

Who it may be forCarcinoid Tumor Lung · Neuroendocrine Tumor of the Lung

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 8, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Not Yet Recruiting

The study is not accepting participants yet.

What kind of study?Early Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Yusuf Menda

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Early Phase 1
Sponsor
Yusuf Menda
Interventions being studied
Drug: 212-Lead Pentixather; Diagnostic Test: 203-Lead Pentixather SPECT/CT
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Study topics
After prior treatment→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Iowa Health CareIowa City, Iowa

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 8, 2025. Always confirm current availability with the study team.

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