TheranosticTrials.org

Clinical Trial · NCT05279027

Zr89 + PET Companion Trial

Overview

Study of Zirconium Zr 89 Crefmirlimab Berdoxa PET/CT as an imaging biomarker for assessing an early response to therapy in patients with advanced melanoma on immunotherapy and hydroxychloroquine. This study is a companion study to the "LIMIT Melanoma Trial." Patients with melanoma who are potentially eligible for the LIMIT Melanoma Trial and have at least one site of measurable disease based on RECIST 1.1 are potentially eligible. Associations with progression-free survival (PFS) and overall survival (OS) will be tested.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Phase

Early Phase 1

ClinicalTrials.gov

NCT05279027

Drug / Compound

Crefmirlimab Berdoxa

Isotope(s):
Target(s):
  • CD8 Cells
Ligand Class: Small Proteins and Antibody Fragments
Chelator: DFO

Eligibility

Inclusion

  • Potentially eligible to participate in the LIMIT Melanoma Trial.
  • At least one site of measurable disease (per RECIST 1.1) that is seen on CT, MRI, or FDG PET/CT.
  • History of histologically confirmed melanoma as assessed per medical record review.

Exclusion

  • Patients who have any splenic disorders, or had splenectomy, that in the opinion of an investigator could compromise protocol objectives.