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Safety Study of 212Pb-Pentixather for Lung Carcinoid and Neuroendocrine Tumors

This is a first-in-human study testing the safety of a new treatment called 212-Lead Pentixather for people with certain lung cancers, specifically atypical carcinoid lesions or neuroendocrine tumors of the lung, who have already received other treatments. 212-Lead Pentixather is designed to target cancer cells using a specific molecule (CXCR4 ligand). To join, you must be at least 18 years old and have healthy bone marrow, kidney, and liver function. The main goal of this study is to find the safest dose of 212-Lead Pentixather. The study plans to enroll 20 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a first-in-human trial focused on determining the safest dose of 212-Lead Pentixather.
What's involved
You would undergo imaging with 203-Lead Pentixather, have blood drawn for calculations, receive kidney-protecting infusions, and get up to two infusions of 212-Lead Pentixather about 6 weeks apart.
Compensation
Not stated in the trial record.
Follow-up
You will undergo imaging at 3 months after treatment to check your disease response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05557708

A Safety Study of 212Pb-Pentixather Radioligand Therapy

Not Yet Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Yusuf Menda
~20 participants
Updated 2025-07-08 on ClinicalTrials.gov
What's tested:212-Lead Pentixather203-Lead Pentixather SPECT/CT

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the recommended phase 2 dose of 212-Lead Pentixather
Measured over 3 months

Conditions

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

Explore related trials

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NCT05557708

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Iowa Health Care

    Iowa City, Iowastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Yusuf Menda, MD · PRINCIPAL_INVESTIGATOR · University of Iowa

Who to contact

Yusuf Menda, MD
[email protected]
319-356-3214
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Determine the recommended phase 2 dose of 212-Lead Pentixather3 months

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