A Safety Study of 212Pb-Pentixather Radioligand Therapy

• Status: Not yet recruiting
• Trial end date: 2028-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yusuf Menda
• Collaborators: Holden Comprehensive Cancer Center; National Cancer Institute (NCI); National Institutes of Health (NIH)

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