Shinilgen announced on the 1st that it has applied to the U.S. Food and Drug Administration (FDA) for approval to change the Investigational New Drug (IND) application for the phase 1 clinical trial of the anticancer candidate substance 'BAL0891'.
The reason for the change application is the addition of a sub-study. Through this IND change, a dose expansion clinical trial targeting patients with triple-negative breast cancer (TNBC) and gastric cancer (GC) will be added.
Shinilgen plans to conduct the clinical trial in two parts: Part 1 will involve BAL0891 monotherapy and combination therapy with carboplatin or paclitaxel in patients with advanced solid tumors, and Part 2 will focus on establishing the recommended phase 2 dose (RP2D) for BAL0891 monotherapy and combination therapy with paclitaxel in patients with triple-negative breast cancer and gastric cancer.
The target number of subjects has also been increased by 96, changing the total recruitment to approximately 216 patients. This is to evaluate not only safety and tolerability, which were the original endpoints, but also efficacy.
A Shinilgen representative stated, "This clinical trial change application is part of a pre-planned clinical protocol, and since no unusual problems or adverse events have been found in the ongoing trial, we are applying for the change and expansion as planned."
Meanwhile, BAL0891 is an anticancer agent in the mitotic checkpoint inhibitor (MCI) class, introduced by Shinilgen from the Swiss company Vasilia.
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