GI Innovation Receives Korean MFDS Approval for Phase 1b/2 Trial of GI-102 + Pasritamig in mCRPC, Adding Major Korean Hospitals and Strengthening Janssen Collaboration
GI Innovation received Korean MFDS approval on May 29, 2026, for a Phase 1b/2 trial of GI-102 combined with pasritamig in metastatic castration-resistant prostate cancer (mCRPC), adding to the earlier FDA approval on April 18, 2026.
The trial will now be conducted at Yonsei University Severance Hospital and Asan Medical Center in Korea, alongside Columbia University Irving Medical Center in the US, enhancing patient recruitment and geographic diversity.
The study is based on a Clinical Trial Collaboration and Supply Agreement with Janssen (signed March 17, 2026), targeting up to 107 patients with an estimated completion by April 2029.
Primary endpoints include dose-limiting toxicity in the safety lead-in phase and PSA response rate (≥50% reduction) in the expansion phase. Clinical success probability is statistically ~10%, and the company may alter plans if results are unsatisfactory.
[AI Comprehensive Analysis]This approval is moderately positive as it expands the trial to top Korean hospitals with Janssen support. However, it is an early-stage trial with high risk of failure; long-term commercialization is uncertain, and investors should monitor interim data cautiously.
KOSDAQ Filing Information
Filing: [Correction of Description] Major Management Matters Related to Investment Decision (Decision on Clinical Trial Plan Approval Application, etc.) (Approval of Phase 1b/2 Clinical Trial Plan to Evaluate Anticancer Activity, Safety, and Tolerability of GI102 in Combination with Pasritamig in Patients with Metastatic Castration-Resistant Prostate Cancer)