Clinical Trial · NCT07577206

Single Microdose Trial- CXCR4 PET Tracer - Pharmacokinetics and Pharmacodynamics of [68Ga]Ga-R54, a Radiopharmaceutical Directed Toward CXCR4 in Patients With Advanced Solid Neoplasia.

Overview

Phase 1, monocentric, open labeled, no profit "Microdose" trial. A single microdose of the new \[68Ga\]Ga-R54 PET radiopharmaceutical directed against CXCR4 will be injected into patients with advanced solid tumor or multiple myeloma to evaluate the binding.

Sponsor

National Cancer Institute

Phase

Early Phase 1

Contacts

Stefania Scala, M.D. (STUDY_DIRECTOR)

Stefania Scala, M.D. (CONTACT)

s.scala@istitutotumori.na.it

08117770596

Secondo Lastoria, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07577206

Drug / Compound

R54

Isotope(s):

Target(s):

CXCR4

Ligand Class: Peptides

Chelator: NOTA

Eligibility

Inclusion

Patients with alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase \<3 x upper limit of reference range and total bilirubin \<2.0 mg/dL
Patients with creatinine \< 1.5 x upper limit of reference range or 24-hour creatinine clearance \> 50 mL/min
Patients with histological diagnosis of solid neoplasm (breast, lung, colon, ovary, pancreas) in advanced stages or multiple myeloma evaluated by PET/CT with \[18F\]FDG carried out in the 3 months prior to enrollment. The neoplasm must express the CXCR4 receptor by immunohistochemistry

Exclusion

Presence of neurodegenerative diseases
Declared chronic active hepatitis (hepatitis B / C)