TheranosticTrials.org

Clinical Trial · NCT07664397

Imaging Study of [89Zr]DFO-YS5 for Cancer Detection

Overview

This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\[89Zr\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.

Sponsor

University of California, San Francisco

Phase

Phase 1

Contacts

Maya Aslam (CONTACT)

maya.aslam@ucsf.edu

877-827-3222

Robert Flavell, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07664397

Drug / Compound

DFO-YS5

Isotope(s):
Target(s):
  • CD46
Ligand Class: Antibodies
Chelator: DFO

Eligibility

Inclusion

  • Histological or cytological confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor neoplasm.
  • Adequate organ function as defined below:
  • Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits).
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50% (see Appendix 1).
  • Estimated creatinine clearance: ≥ 60 mL/min, calculated using the Cockcroft-Gault equation.
  • At least one soft tissue lesion measurable at 1 cm or greater in short axis measurement on cross sectional imaging such as Computerized tomography (CT), magnetic resonance imaging (MRI), or Positron Emission Tomography (PET)/CT (scan imaging as documented in the medical record). Exception: For participants with localized bladder cancer (pre-cystectomy), lesions smaller than 1 centimeter (cm) are permitted, provided there is cystoscopic confirmation of a bladder mass.

Exclusion

  • Hypersensitivity to \[89Zr\]DFO-YS5 or any of its excipients.