On September 8, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported that the first patient has been dosed in the Phase 1/2 clinical trial of NT219, a dual inhibitor, novel small molecule targeting IRS1/2 and STAT3, important oncogenic drivers and major drug resistance pathways in many hard-to-treat cancers (Press release, Kitov Pharmaceuticals , SEP 8, 2020, View Source [SID1234565050]).

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"The dosing of the first patient in this important study represents a significant milestone for Kitov," said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Kitov. "Based on the encouraging pre-clinical data generated by NT219 as both monotherapy and in combination with several anti-cancer drugs, we believe that this promising drug candidate has the potential to be a safe and effective therapy for multiple hard-to-treat cancers. We are satisfied with the progress of the study and anticipate full enrollment in this first part of the study as planned, with top line data from the first part of the study expected in the second half of 2021."

The Phase 1/2 trial is evaluating NT219 as monotherapy treatment of advanced solid tumors, as well as in combination with cetuximab, an epithelial growth factor receptor (EGFR) blocking monoclonal antibody, for the treatment of recurrent and/or metastatic solid tumors and head and neck cancer or colorectal adenocarcinoma.

The primary objectives of the open-label Phase 1/2 trial are to evaluate safety, assess pharmacokinetics, identify the recommended dose to be studied in the Phase 2 portion, and establish preliminary efficacy of NT219. The Phase 1 portion of the study will encompass a dose escalation evaluation of NT219 monotherapy administered weekly in patients with refractory advanced solid tumors. Upon reaching the third dose level of NT219, a second cohort of patients, with recurrent or metastatic squamous cell carcinoma of the head and neck or colorectal adenocarcinoma, will be administered weekly with NT219, dose escalated, in combination with cetuximab.

Upon completion of the monotherapy and combination therapy Phase 1 portions of the trial and establishment of the recommended Phase 2 dose for NT219, Kitov plans to commence an expansion Phase 2 component of the study at that dose in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. The trial will also include exploratory evaluations of different potential biomarkers in patient tumors and serum. Further Phase 2 arms in patients with different malignancies, as a monotherapy or in combination with other cancer therapies, will be considered based on the exploratory evaluations and the data generated during the Phase 1 portions of the trial. The study is anticipated to be conducted at multiple medical centers in North America.