Cancer Targeted Technology (CTT) has initiated a Phase 1 clinical trial evaluating the safety and sensitivity of its positron emission tomography (PET) imaging agent, CTT1057, in detecting prostate cancer cells in patients with both localized and metastatic disease.
The trial is supported by a $2 million Small Business Innovation Research (SBIR) grant, and imaged its first patients in early November.
CTT1057, which was designated an Investigational New Drug by the U.S. Food and Drug Administration in August, is a radiolabeled (fluorine-18) antibody that binds to the prostate cancer biomarker PSMA irreversibly, enhancing the imaging agent’s uptake by cancer cells. Because PSMA is expressed at high levels in prostate cancer cells, and these levels further increase if a cancer metastasizes and becomes castrate-resistant, CTT1057 holds promise in detecting metastasis with better accuracy and sensitivity than current methods.
“FDA clearance and start of our first clinical trial are significant milestones for CTT as we transition to a clinical phase company. CTT’s PSMA-targeted drugs are unique,” Beatrice Langton-Webster, CTT’s CEO and a principal investigator on the National Institutes of Heath’s SBIR, said in a press release. “Our diagnostic agent, CTT1057, will be used alone or with our companion radiotherapeutic drug, CTT1403, targeting metastatic prostate cancer, currently undergoing IND-enabling studies.”
The first-in-human trial (NCT02916537), which is currently recruiting, will enroll 20 patients in two distinct cohorts; cohort A will include five patients with prostate cancer prior to radical prostatectomy, and cohort B will include 15 metastatic and castration-resistant prostate cancer patients. Patients will receive a single dose of CTT1057 at the beginning of the study to assess the agent’s safety and pharmacokinetics, as well as its sensitivity and specificity in detecting cancer lesions.
Those in cohort A will undergo radical prostatectomy plus lymph node dissection within 12 weeks following the imaging procedure. Cohort B patients will have the option of undergoing a metastatic tumor biopsy.
“We … look forward to the results of these key studies,” Dr. Henry VanBrocklin, director of the Radiopharmaceutical Research Program, said. VanBrocklin worked with CTT on the initial development of CTT1057, and will be directing the drug’s radiolabeling at the University of California, San Francisco, where the single-center trial is taking place.