Overview

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

Status:
Completed
Trial end date:
2018-08-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cancer Targeted Technology
Collaborator:
University of California, San Francisco
Criteria
Inclusion Criteria:

- Patients age ≥18 years old

- Histologically confirmed renal cell carcinoma

- 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 participants of childbearing potential, not pregnant, and use of effective
contraceptive methods during the trial and within 6 months following radiotracer
injection

- 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

- Cohort B only: (N = 5 evaluable patients): Planned nephrectomy within 12 weeks
following protocol scan

Exclusion Criteria:

- Patients with or with a history of uncontrolled bleeding diathesis

- 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.

- Prior history of any other malignancy within past three years, except melanomatous
skin cancer or carcinoma in situ.