TCD is currently conducting Phase I clinical studies with its leading product TCD-717, a first-in-class choline kinase alpha (ChoKα) inhibitor. The study has been approved by the FDA as part of an Investigational New Drug (IND) application, and is being conducted in two medical centers in the U.S.
Objectives: The trial is designed to primarily assess the safety and tolerability, pharmacokinetics and preliminary efficacy of TCD-717 given by intravenous infusion in patients with advanced solid tumors.
Trial design: Each patient will receive 2 administrations of TCD-717 per week for a total of 6 cycles in the course of 28 days, unless disease progression or dose limiting toxicity occurs. Patients who do not have progressive disease after the last treatment will be offered to continue treatment. Blood chemistry, hematology, vital signs, electrocardiogram, ophthalmological and physical examinations will be conducted at regular intervals. Patients will be enrolled in ascending dose cohorts of 3 patients and will be monitored for evidence of dose-limiting toxicity. Once the maximum tolerated dose is reached, additional patients will be enrolled to confirm this dose.
Inclusion/exclusion criteria: To be eligible to participate in this study, adult patients must have histologically-confirmed solid tumors, metastatic or recurrent and refractory disease after standard therapy for the disease or for which conventional therapy is not reliably effective or no effective therapy is available.
For more information, please go to ClinicalTrials.gov
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