- MFDS Amendment Approved, with Additional Cohorts and Stepwise Dose Escalation Introduced

GI Innovation announced on July 10, 2026, that it has received approval from the Ministry of Food and Drug Safety (MFDS) for an amendment to the Phase 1/2a clinical trial protocol of its investigational solid tumor therapy, GI-108.

The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of GI-108 as a monotherapy in patients with advanced or metastatic solid tumors.

This is an open-label, multicenter clinical trial that will enroll up to 102 patients at Severance Hospital of Yonsei University College of Medicine, Samsung Medical Center, and Asan Medical Center.

The protocol amendment was submitted to the MFDS on June 8, 2026, and received final approval approximately one month later, on July 10, 2026.

The key amendments include the addition of dose-escalation cohorts, an increase in the number of patients for expansion cohorts, and the introduction of a step-up dosing strategy.

According to the company, the clinical trial is expected to span approximately three years, with completion anticipated on December 11, 2029.

GI-108 is a bispecific fusion protein being co-developed by GI Innovation and MediRama, a company specializing in clinical development and regulatory strategy.

Source: Data Investment (지아이이노베이션, 메디라마 공동개발 'GI-108' 임상 변경승인…2029년 완료 목표)