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

Completed · Phase 1

Conditions studied: Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT03427476

Run by

Cancer Targeted Technology

People needed

4

Starts

2018-01-01

Expected to finish

2018-08-31

Last updated by the study team

2019-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.