Kitov Pharma Limited has reportedly announced its dosing of the first patient in the Phase 1/2 clinical trial of NT219. The candidate is a novel small molecule targeting STAT3 and IRS1/2, major drug resistance pathways and important oncogenic drivers in numerous hard-to-treat cancers.
As per sources, the Phase 1/2 trial focuses on the evaluation of NT219 as monotherapy for the treatment of advanced solid tumors. The trial also intends to test the integration of NT219 with an EGFR called cetuximab, which is responsible for blocking monoclonal antibody, in the treatment of metastatic and/or recurrent solid tumors and colorectal adenocarcinoma or head and neck cancer.
According to Bertrand Liang, the Chief Medical Officer of Kitov, the dosing of the first patient in this significant study is a representation of a major milestone for the company. He has also stated that on the basis of the encouraging pre-clinical data obtained from NT219 in the form of monotherapy and in collaboration with numerous anti-cancer drugs, this promising drug candidate is believed to have the potential to evolve as an effective and safe therapy for numerous hard-to-treat cancers.
The company is satisfied with the advancements in this study and speculates complete enrollment in the first part, with top line data likely to be obtained from the first part of the study in the second half of 2021, added Liang.
As per reports, Kitov has decided to begin an expansion of the Phase 2 component of the clinical study at a recommended dose along with cetuximab, in patients having metastatic or recurrent squamous cell carcinoma of the neck and head. The decision will be implemented upon the completion of combination therapy and monotherapy Phase 1 portions of the trial and the establishment of the recommended dose for NT219 in the second phase.
The trial will also comprise exploratory evaluations of myriad potential biomarkers in patient serum and tumors and is likely to be conducted at several medical centers in North America, cite sources.