On February 24, 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 it will expand the planned Phase 1/2 clinical trial of NT-219 with cetuximab trial in patients with recurrent or metastatic head and neck cancer, to also include evaluation of NT-219 as monotherapy treatment in patients with advanced solid tumors (Press release, Kitov Pharmaceuticals , FEB 24, 2020, View Source [SID1234554647]). Kitov expects to initiate this study in the second quarter of 2020, pending clearance of its Investigational New Drug application by the U.S. Food and Drug Administration. NT-219 is a small molecule dual inhibitor of IRS1/2 and STAT3, pathways associated with treatment resistance.

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The details of the planned Phase 1/2 trial will be presented in a poster at the 2020 Multidisciplinary Head and Neck Cancers Symposium, which is being held in Scottsdale, Arizona, from February 27-29, 2020. The presentation will include details of the Phase 1/2 study, as well as new preclinical data demonstrating the anti-tumor activity of NT-219 as both a monotherapy and in combination with cetuximab, an epithelial growth factor receptor (EGFR) blocking monoclonal antibody.

"Our strategic decision to expand our planned clinical study to evaluate NT-219 as monotherapy is based on the significant compelling preclinical evidence generated in various studies with NT-219, including the data we will be presenting this week," said Isaac Israel, chief executive officer of Kitov. "The promising preclinical data demonstrate the anti-cancer potential of NT-219, both as a monotherapy and in combination with cetuximab, anti-PD1 inhibitors and other agents. We expect that the establishment of standalone safety data and potential efficacy will provide a solid foundation for further evaluation of NT-219 in a number of different clinical settings. We look forward to advancing NT-219 into the clinic in the second quarter of this year."

The Phase 1/2 study will be an open-label, dose escalation and subsequent expansion phase study. The study will have a dose escalation component of NT-219 as a single agent; a dose escalation phase of NT-219 in combination with cetuximab; and an expansion phase of NT-219 at its recommended Phase 2 level in combination with a standard dose of cetuximab. Advanced solid tumors, as well as recurrent or metastatic squamous cell carcinoma of the head and neck, will be evaluated. Other possible expansion cohorts will be determined based on the Phase 1 dose escalation and further preclinical data.

The primary objectives of the study will be to assess plasma pharmacokinetics, safety, tolerability and maximum tolerated dose of NT219 as a single agent, and in combination with cetuximab. The secondary objectives will be to assess pharmacokinetics and efficacy of different dose levels of NT219, alone and in combination with cetuximab.

Presentation details are as follows:

Abstract Title: A Phase 1/2, Open-Label, Dose Escalation Followed by Single-Arm Expansion to Assess the Safety and Efficacy of NT219 in Combination with Cetuximab in Patients with Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC)

Date: February 27-29, 2020
Presentation number: 312
Session: Poster
Location: Exhibit Hall

The poster will also be available for download from February 27, 2020 at: View Source