Kazia Therapeutics’ EVT801 Phase 1 clinical trial completes Phase 1 objectives

Kazia Therapeutics announced that the Safety Review Team 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. The SRT has reviewed all preliminary safety and pharmacokinetic data, and unanimously agreed that the maximal tolerated dose has been reached at 500mg twice a day. 400mg BID was identified as the starting recommended phase 2 dose. EVT801 was tolerated across all doses with the majority of toxicities being mild to moderate and transient in nature. Eleven different cancer types were enrolled in the study, with advanced ovarian cancer being the most prevalent. 46% of the ovarian cancer patients had stable disease or better for at least three cycles of EVT801 therapy. 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 expects to share the final stage 1 data and next development steps at an upcoming scientific conference in the second half of 2024.