TheranosticTrials.org

Clinical Trial · NCT03427476

CTT1057, a Small Molecular Inhibitor of PSMA, as a Novel Imaging Agent of Neovascularization in Renal Cell Carcinoma

Overview

The purpose of this study is to test a novel diagnostic PET imaging agent for safety and biodistribution. The agent binds PSMA and is designed to detect Prostate Specific Membrane Antigen expressing tumors, such as has been described for some renal cell carcinoma tumors.

Sponsor

Cancer Targeted Technology

Phase

Phase 1

Contacts

Beatrice Langton-Webster, PhD (STUDY_CHAIR)

ClinicalTrials.gov

NCT03427476

Drug / Compound

CTT1057

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Cohort A only: Presence of at least three distinct metastatic lesions by standard imaging including whole body bone scan + cross-sectional imaging of the abdomen and pelvis obtained within 12 weeks prior to protocol scan
  • Histologically confirmed renal cell carcinoma
  • Adequate organ function including:
  • \- Platelet count of \> 50,000/mm3
  • \- Total bilirubin \< 1.5 x ULN (\< 3 x ULN in patients with known/suspected Gilbert's disease)
  • Cohort B only: (N = 5 evaluable patients): Planned nephrectomy within 12 weeks following protocol scan
  • \- Neutrophil count of \> 1000/mm3
  • \- Proteinuria \< 1 g/24 hours based upon 24 hour urine collection or spot urine protein/creatinine ratio
  • \- Serum Cr \< 1.5 x ULN or estimated GFR \> 60 ml/min based upon Cockroft-Gault equation
  • ECOG performance status of 0 or 1
  • \- AST and ALT \< 2.5 x ULN (\< 5 x ULN in patients with known liver metastases)
  • No contra-indication to MR including severe claustrophobia, incompatible aneurysm clips or cardiac pacemaker
  • For participants of childbearing potential, not pregnant, and use of effective contraceptive methods during the trial and within 6 months following radiotracer injection

Exclusion

  • Inadequate venous access per assessment of treating health care provider
  • Patients with or with a history of uncontrolled bleeding diathesis
  • Have a medical condition or other circumstances that, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the trial.
  • Prior treatment with alpha radiation therapy (Radium Ra 223 chloride; Xofigo™) during the previous 60 days
  • Receipt of radioisotope within 5 physical half-lives prior to trial enrollment