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A Safety Study of 212Pb-Pentixather Radioligand Therapy

ConditionsCarcinoid Tumor LungNeuroendocrine Tumor of the LungCarcinoma, Small-Cell Lung
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorYusuf Menda

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: 212-Lead PentixatherExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yusuf Menda

Lead sponsor

University of Iowa

Sponsor institution

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator

Holden Comprehensive Cancer Center

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: