Phase 1 Trial of Dosimetry Guided 212Pb-pentixather Radioligand Therapy in Patients With Atypical Lung Carcinoids and Neuroendocrine Carcinomas

202209363

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.

2024-07-01

2026-06-30

2028-06-30

Not yet recruiting

Early phase I

20

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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2023-11-18