GI Innovation said Friday it has received approval from the Ministry of Food and Drug Safety (MFDS) for a phase 2 trial of its investigational drug GI-102 in combination with Keytruda for metastatic melanoma.
The study will compare the combination against Keytruda monotherapy in a randomized trial.
Following earlier approval from the U.S. FDA, the latest investigational new drug (IND) clearance in Korea is expected to accelerate global phase 2 development of GI-102.
The trial will enroll previously untreated patients with metastatic melanoma and randomly assign them to receive either standard-of-care Keytruda alone or the GI-102 combination. A randomized design -- the gold standard in clinical research -- helps ensure an objective assessment of efficacy and safety.
If the combination demonstrates superiority over Keytruda alone, GI-102 could emerge as a new first-line treatment option for metastatic melanoma. Such results would also support broader use of GI-102 in combination with immune checkpoint inhibitors, the company said.
The study will be conducted at leading cancer centers named among the world’s best hospitals by Newsweek in 2026, including Mayo Clinic, Cleveland Clinic, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Samsung Medical Center, and Asan Medical Center.
The company said participation by these centers should support high-quality data generation. Additional GI-102 programs, including subcutaneous (SC) monotherapy, antibody-drug conjugate (ADC) combinations, and further Keytruda combinations, are also underway.
GI-102, a next-generation immuno-oncology candidate, has also been selected for the MFDS’s “Giljabi” program, which aims to accelerate development of innovative therapies with high unmet need.
The program provides end-to-end regulatory support—from early development to approval -- including consultation and guidance. GI-102 was selected through a rigorous evaluation process, and the company has already received multiple rounds of regulatory consultation.
Selected products are assigned a dedicated project manager to provide continuous, tailored support throughout development. The Giljabi program is also linked to the expedited review pathway (GIFT), enabling more efficient commercialization through pre-review of submission materials and other regulatory support.
“Facing reimbursement challenges, Korean metastatic melanoma patients often struggle to access optimal care,” GI Innovation CEO Jang Myoung-ho said. “We are committed to accelerating commercialization and delivering new hope to patients with rare cancers.”
Lee Han-soo
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