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

• Status: Completed
• Trial end date: 2017-08-28
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Targeted Technology
• Collaborator: University of California, San Francisco

Criteria

Inclusion Criteria:

• Male patients age ≥18 years old

• Histologically confirmed adenocarcinoma of the prostate

• Adequate organ function including:

• - Platelet count of > 50,000/mm3

• - Neutrophil count of > 1000/mm3

• - Serum Cr < 1.5 x ULN or estimated GFR > 60 ml/min based upon Cockroft-Gault equation

• - Proteinuria < 1 g/24 hours based upon 24 hour urine collection or spot urine protein/creatinine ratio

• - AST and ALT < 2.5 x ULN (< 5 x ULN in patients with known liver metastases)

• - Total bilirubin < 1.5 x ULN (< 3 x ULN in patients with known/suspected Gilbert's disease)

• ECOG performance status of 0 or 1

• Able to provide written informed consent and willing to comply with protocol requirements

• No contra-indication to MR including severe claustrophobia, incompatible aneurysm clips or cardiac pacemaker

• For men of childbearing potential, the use of effective contraceptive methods during the trial and within 6 months following radiotracer injection

• Cohort A only (N = 5 evaluable patients):- Planned radical prostatectomy within 12 weeks following protocol scan

• - No androgen deprivation, anti-androgen therapy, chemotherapy, or investigational systemic therapy prior to CTT1057 PET imaging

• 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

• - Castration-resistant disease as defined by PCWG2 criteria

• - Must remain on androgen deprivation therapy for duration of trial if no prior bilateral orchiectomy

Exclusion Criteria:

• 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

• 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.

• Histologic evidence of small cell prostate cancer or neuroendocrine differentiation in > 50% of biopsy tissue