XCancer

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

Description:

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)

Government Study Link:

NCT07577206 - Click here to see study on

ClinicalTrials.gov

R54

Isotope(s):
Target(s):
  • CXCR4
Ligand Class: Peptides
Chelator: NOTA
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)