GI Innovation has applied to the Ministry of Food and Drug Safety (MFDS) for approval to change the clinical trial plan for its solid tumor treatment candidate, 'GI-108'.

According to the regulatory filing on June 8, this clinical trial is a study to evaluate the safety, tolerability, pharmacokinetics (PK), and therapeutic efficacy of GI-108 monotherapy in patients with progressive or metastatic solid tumors. The clinical trial will be conducted at Severance Hospital of Yonsei University College of Medicine, Samsung Medical Center, and Asan Medical Center, with a total clinical trial period planned for approximately 3 years.

• *[Main Contents of the Change Application]**
• Through this application for change, the company intends to pursue the following:
• Addition of cohorts in the dose escalation phase
• Change in the number of enrolled subjects due to the expansion of the supplementary cohort
• Introduction of a 'Step-up dosing' strategy, an adaptive design element applicable to the dose escalation phase

Accordingly, the target number of trial subjects has been set at a maximum of 102.

[Evaluation Variables and Clinical Objectives] The clinical trial consists of a dose escalation phase and a dose expansion phase. The primary evaluation variable in the dose escalation phase is to evaluate the incidence and characteristics of dose-limiting toxicity (DLT), adverse events, and immunological adverse events. Meanwhile, in the dose expansion phase, the objective response rate (ORR) will be measured, and the 95% confidence interval for ORR is planned to be calculated using the Clopper-Pearson method.

The main objective of this clinical trial is to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of GI-108, and subsequently confirm its anti-tumor activity.

[Reference and Investment Notes] The company stated, "The date of occurrence is the date on which the application for approval of the change to the clinical trial plan was submitted to the Ministry of Food and Drug Safety."

Meanwhile, the company's regulatory filing included an investment note stating that the statistical probability of the clinical trial drug leading to final drug approval is approximately 10%, and that there is a possibility the commercialization plan may be changed or suspended depending on the clinical trial results.