Shinilajen announced on the 1st that it has applied to the U.S. Food and Drug Administration (FDA) for approval to change the phase 1 clinical trial plan (IND) for the anticancer candidate substance 'BAL0891'.
BAL0891 is an anticancer drug in the mitotic checkpoint inhibitor (MCI) class introduced by Shinilajen from the Swiss company Vasillia. It is the first new drug in its class to simultaneously inhibit two enzymes, threonine tyrosine kinase (TTK) and polo-like kinase 1 (PLK1), and clinical trials are progressing smoothly in the United States and Korea.
The reason for the change application is to add a sub-study that includes a dose expansion clinical trial targeting patients with triple-negative breast cancer and gastric cancer. Accordingly, Shinilajen plans to conduct the clinical trial in two parts: Part 1 will involve patients with advanced solid tumors receiving BAL0891 alone or in combination with carboplatin or paclitaxel, and Part 2 will establish the recommended phase 2 dose (RP2D) and involve patients with triple-negative breast cancer and gastric cancer receiving BAL0891 alone or in combination with paclitaxel. The target number of subjects will also increase by 96, recruiting approximately 216 patients in total. This expansion aims to evaluate not only safety and tolerability, which were the original endpoints, but also efficacy.
A Shinilajen official stated, "This clinical trial change application is part of the pre-planned clinical protocol," adding, "No unusual problems or adverse events have been found in the ongoing trial, so we are applying for the change and expansion as planned."
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