SillaJen announced on Jan. 1 that it has applied to the U.S. Food and Drug Administration (FDA) for approval to amend the Investigational New Drug (IND) application for Phase 1 clinical trials of its BAL0891 cancer drug candidate.
BAL0891 is a mitotic checkpoint inhibitor (MCI) class anticancer drug that SillaJen has introduced from Basel, a Switzerland-based company. The reason for the IND amendment application is to add a sub-study, which, through this IND amendment, will add a dose-expansion clinical trial for patients with triple-negative breast cancer and gastric cancer.
Accordingly, SillaJen plans to conduct the clinical trials in two parts: Part 1 involves administering BAL0891 alone and in combination with carboplatin or paclitaxel to patients with advanced solid tumors; Part 2 involves establishing the Recommended Phase 2 Dose and then administering BAL0891 alone and in combination with paclitaxel to patients with triple-negative breast cancer and gastric cancer.
The target number of participants has also been changed to recruit a total of about 216 people, adding 96 more. This change is intended to evaluate not only the original endpoints of safety and tolerability but also efficacy.
A representative from SillaJen stated, “This application to amend the clinical trial is part of a pre-planned clinical strategy. We are applying for changes and expansions as planned because no unique problems or abnormalities have been discovered in the ongoing clinical trials.”