Kazia Therapeutics has announced the successful completion of the first stage of the Phase I clinical trial of EVT801 monotherapy in patients with advanced cancer.
The trial’s Safety Review Team (SRT) has confirmed that the study has met its primary and secondary objectives for this stage.
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The dose-finding, open-label study is focused on evaluating the safety, tolerability, and pharmacokinetics (PK) of EVT801 in subjects with advanced or metastatic solid tumours who are not responsive to standard treatment or for whom no standard therapy is available.
It enrolled patients with eleven different types of advanced or metastatic solid tumours, including ovarian cancer, which was the most prevalent among the participants.
The primary objective of the trial was to assess the safety and tolerability of EVT801 as well as to establish the maximal tolerated dose (MTD) and / or a recommended Phase II dose (RP2D) of EVT801 daily dose.
Secondary objectives included characterising the PK profile of the oral capsule formulation of EVT80, identifying active metabolites of EVT801 in plasma, and detecting initial anti-tumour activity.
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By GlobalDataTo validate the trial objectives, the SRT reviewed all initial safety and PK data, reaching a consensus that the MTD is 500mg administered twice a day (BID).
For future trials, an RP2D of 400mg BID has been identified, assuming continuous monotherapy administration.
In the trial, EVT801 was found to be well-tolerated across all tested doses, with most of the toxicities being mild to moderate and transient in nature.
Notably, 46% of ovarian cancer patients experienced stable disease or better for at least three cycles of EVT801 therapy.
Kazia Therapeutics CEO Dr John Friend said: “We are extremely pleased that the primary and secondary endpoints of stage one of Phase I 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 programme for EVT801 as a potential first-in-class VEGFR3 inhibitor.
“With a median survival time of less than four years, there is a large unmet need for new therapies in patients with high-grade serous ovarian cancer.”
In February 2022, the company commenced a Phase II trial of paxalisib along with metformin and a ketogenic diet to treat recently diagnosed and recurrent glioblastoma.
