South Korean biotech firm GI Innovation is collaborating with Merck & Co. (MSD) to assess GI-102 in combination with Keytruda (pembrolizumab) for treating various cancers. The Phase II trial will focus on patients with metastatic liver cancer, melanoma, and renal cell carcinoma who have developed resistance or non-responsiveness to immuno-oncology treatments.
Trial Design and Locations
The Phase II trial will be conducted across 14 hospitals in South Korea, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Severance Hospital of Yonsei University, and St Vincent’s Hospital. It will also be carried out at US sites, such as the Mayo Clinic campuses in Rochester, Florida, and Arizona, as well as Cleveland Clinic and Memorial Sloan Kettering Cancer Center.
GI-102 Efficacy
GI-102 has shown promising anti-cancer efficacy in previous studies. In melanoma patients who did not respond to standard treatments, GI-102 achieved a 42.9% overall response rate (ORR), with three partial responses out of seven patients. Preclinical studies also demonstrated that GI-102 monotherapy led to complete tumor regression in 60% of mice with liver cancer.
Executive Insights
GI Innovation chief scientific officer Dr. Myung-Ho Jang stated, “We are pleased to enter into another clinical trial collaboration and supply agreement with MSD, a world leader in immuno-oncology. We aim to maximize the therapeutic value of GI-102 by combining it with KEYTRUDA, MSD’s anti-PD-1 therapy.”
Prior Collaborations
This partnership marks GI Innovation’s second trial collaboration with MSD, following an earlier agreement involving GI-101A. The focus remains on developing innovative treatments for patients with limited options due to resistance to existing therapies.