Shinilajen announced on the 14th that it has received approval for the clinical trial plan (IND) from the Ministry of Food and Drug Safety for 'BAL0891' monotherapy and combination therapy with chemotherapy in patients with advanced solid tumors.
This clinical trial is a Phase 1 study of monotherapy and combination therapy with carboplatin or paclitaxel in adult patients with advanced solid tumors.
Through the clinical trial, Shinilajen plans to evaluate the safety, tolerability, pharmacokinetics, and anticancer effects of BAL0891 monotherapy, and based on interim analysis results, will assess safety and efficacy in a larger patient population.
Shinilajen is currently conducting a Phase 1 clinical trial of BAL0891 in the United States as well. The first patient enrollment for the Phase 1 trial has been completed at the Oregon Health & Science University Knight Cancer Institute (OHSU) in Portland, Oregon, and Phase 1 trials are ongoing at four other major institutions.
A Shinilajen representative stated, "Following the United States, domestic regulatory authorities have also approved the Phase 1 trial of BAL0891, so we expect the clinical development to gain momentum. We will strive to become a 'First-in-class' new drug by targeting the oncology market with high unmet needs."
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