TheranosticTrials.org

Clinical Trial · NCT02826382

Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041

Overview

A phase1 study to demonstrate \[68Ga\]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.

Sponsor

Five Eleven Pharms Inc.

Phase

Early Phase 1

ClinicalTrials.gov

NCT02826382

Drug / Compound

P15-041

Isotope(s):
Target(s):
  • Bone Metabolism
Ligand Class: Small Molecules
Chelator: HBED-CC

Eligibility

Inclusion

  • histologically confirmed prostate cancer. known or suspected bone metastases referred for a clinical \[99mTc\]MDP scan

Exclusion

  • Estimated creatinine clearance (GFR) \< 30 mL/min (calculated), history of hyperparathyroidism, • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician, • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study