A Safety Study of 212Pb-Pentixather Radioligand Therapy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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:

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05557708
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Yusuf Menda
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yusuf Menda, MD
Principal Investigator Affiliation	University of Iowa
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Carcinoid Tumor Lung, Neuroendocrine Tumor of the Lung, Carcinoma, Small-Cell Lung

Additional Details

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

Arms & Interventions

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.

Interventions

Drug: - 212-Lead Pentixather

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

Diagnostic Test: - 203-Lead Pentixather SPECT/CT

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Iowa City, Iowa

Status

Address

The University of Iowa Theranostics Center

Iowa City, Iowa, 52242

Site Contact

Yusuf Menda, MD

[email protected]

319-356-3214

Clinical Trial Finder