On May 1, 2024 Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specialising in oncology, reported that the Safety Review Team (SRT) of the EVT801 Phase 1 clinical trial has concluded that the primary and secondary objectives of stage 1 of the trial have successfully been met (Press release, Kazia Therapeutics, MAY 1, 2024, View Source [SID1234642521]).
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Consisting of the trial’s lead investigators, independent medical monitor, and key members from Kazia Therapeutics, the SRT has reviewed all preliminary (non-final) safety and pharmacokinetic (PK) data, and unanimously agreed that the maximal tolerated dose (MTD) has been reached at 500mg twice a day (BID). Under the condition that continuous monotherapy administration will be used in future clinical trials, 400mg BID was identified as the starting recommended phase 2 dose (RP2D).
A total of 26 patients received EVT801 across six dosing cohorts ranging from 50mg daily to 500mg BID. In general, EVT801 was tolerated across all doses with the majority of toxicities being mild to moderate and transient in nature. Eleven different cancer types (ex. colon, renal cell, pancreatic) were enrolled in the study, with advanced ovarian cancer being the most prevalent (11 patients). These 11 patients had an average age of 67 years (range: 56-76) and a median time from diagnosis of nine years. Forty-six percent (46%) of the ovarian cancer patients had stable disease or better for at least three cycles of EVT801 therapy.
EVT801 is a highly selective small molecule VEGFR3 tyrosine kinase inhibitor targeting tumour angiogenesis. Unlike traditional angiokinase inhibitors, we believe based on preclinical data that EVT801 has favorable immune activity (reduces immunosuppressive cells and no impact on CD3+ T-cells proliferation) and stabilizes tumor blood vessels, minimizing hypoxia and therefore decreases the potential for metastatic spread. The Phase 1 EVT801 monotherapy dose-finding trial targets patients with histologically confirmed advanced or metastatic solid tumours that are unresponsive to standard treatment, or for whom no standard treatment is available or appropriate.
Kazia Therapeutics CEO, Dr. John Friend said: "We are extremely pleased that the primary and secondary end points of stage 1 of the Phase 1 clinical trial have been met. The signals of clinical activity, especially in patients with advanced ovarian cancer are highly encouraging as we continue to progress the clinical development program for EVT801 as a potential first-in-class VEGFR3 inhibitor. With a median survival time of less than 4 years, there is a large unmet need for new therapies in patients with high-grade serous ovarian cancer."
The Phase 1, open label study is designed to assess the safety, tolerability, and PK of EVT801 in patients with advanced or metastatic solid tumors unresponsive to standard treatment, or for whom no standard treatment is available or appropriate.
Primary Objective:
• To evaluate the safety and tolerability of EVT801 in subjects with advanced or metastatic solid tumours.
• To determine the MTD and / or a RP2D of EVT801 when administered daily to subjects with advanced or metastatic solid tumours.
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Secondary Objectives:
• To characterise the PK of EVT801 following administration in an oral capsule formulation.
• To identify active metabolites of EVT801 in plasma.
• To determine preliminary anti-tumour activity of EVT801 via assessment of overall response rate.
We look forward to sharing the final stage 1 data and next development steps at an upcoming scientific conference in the second half of 2024.