[Edaily Reporter Son Min-ji] #GI Innovation announced on the 8th that it has submitted an application to the Ministry of Food and Drug Safety (MFDS) for approval of a protocol amendment for the Phase 1/2a clinical trial of its immuno-oncology drug ‘GI-108’.

This clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and therapeutic efficacy of GI-108 monotherapy in patients with advanced or metastatic solid tumors. The trial is scheduled to enroll up to 120 participants and will be conducted over approximately three years at Severance Hospital (Yonsei University College of Medicine), Samsung Medical Center, and Asan Medical Center.

Through this amendment application, GI Innovation is modifying parts of the clinical trial design, including adding a cohort for the dose-escalation phase and expanding the size of the supplementary cohort. Accordingly, the number of eligible trial participants will also be adjusted.

The company is also introducing a “step-up dosing” strategy, an adaptive design element applicable to the dose-escalation cohort.

Meanwhile, this clinical trial consists of a dose-escalation phase and a dose-expansion phase. During the dose-escalation phase, the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) will be defined, and safety and tolerability will be evaluated. Subsequently, during the dose-expansion phase, the antitumor activity of GI-108 will be evaluated based on the established dose.