TheranosticTrials.org

Clinical Trial · NCT02916537

A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, and [18F] Radiation Dosimetry of CTT1057

Overview

The purpose of this study is to test a novel diagnostic Positron Emission Tomography (PET) imaging agent for safety and biodistribution. The agent binds Prostate Specific Membrane Antigen (PSMA) and is designed to detect prostate tumors.

Sponsor

Cancer Targeted Technology

Phase

Phase 1

Contacts

Beatrice Langton-Webster, PhD (STUDY_CHAIR)

ClinicalTrials.gov

NCT02916537

Drug / Compound

CTT1057

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

Eligibility

Inclusion

  • \- Castration-resistant disease as defined by PCWG2 criteria
  • \- Neutrophil count of \> 1000/mm3
  • \- Serum Cr \< 1.5 x ULN or estimated GFR \> 60 ml/min based upon Cockroft-Gault equation
  • Cohort A only (N = 5 evaluable patients):- Planned radical prostatectomy within 12 weeks following protocol scan
  • \- Platelet count of \> 50,000/mm3
  • Adequate organ function including:
  • For men of childbearing potential, the use of effective contraceptive methods during the trial and within 6 months following radiotracer injection
  • \- Must remain on androgen deprivation therapy for duration of trial if no prior bilateral orchiectomy
  • \- No androgen deprivation, anti-androgen therapy, chemotherapy, or investigational systemic therapy prior to CTT1057 PET imaging
  • \- Total bilirubin \< 1.5 x ULN (\< 3 x ULN in patients with known/suspected Gilbert's disease)
  • No contra-indication to MR including severe claustrophobia, incompatible aneurysm clips or cardiac pacemaker
  • ECOG performance status of 0 or 1
  • Cohort B 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
  • \- AST and ALT \< 2.5 x ULN (\< 5 x ULN in patients with known liver metastases)
  • \- Proteinuria \< 1 g/24 hours based upon 24 hour urine collection or spot urine protein/creatinine ratio
  • Histologically confirmed adenocarcinoma of the prostate

Exclusion

  • Histologic evidence of small cell prostate cancer or neuroendocrine differentiation in \> 50% of biopsy tissue
  • 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.
  • Inadequate venous access per assessment of treating health care provider
  • Receipt of radioisotope within 5 physical half lives prior to trial enrollment
  • Prior treatment with alpha radiation therapy (Radium Ra 223 chloride; Xofigo™) during the previous 60 days