GI Innovation has submitted a clinical trial plan for a combination therapy targeting metastatic castration-resistant prostate cancer patients in both South Korea and the U.S.
On Thursday, according to the Financial Supervisory Service’s electronic disclosure system, GI Innovation filed an Investigational New Drug (IND) application with the Korean Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA). The application aims to evaluate the anti-cancer activity, safety, and tolerability of the combination therapy using GI-102 and Janssen’s pasritamig in a Phase 1b/2 clinical trial.
The clinical trial, a multicenter Phase 1b/2 open-label study, will assess the anti-cancer activity, safety, and tolerability of the GI-102 and pasritamig combination therapy in patients with metastatic castration-resistant prostate cancer who have not responded to new hormone therapy. Participating institutions include Severance Hospital and Asan Medical Center in South Korea, along with Columbia University Irving Medical Center in the U.S.
Through this clinical trial, the company plans to determine the maximum tolerable dose of GI-102 or the recommended Phase 2 dose for the combination therapy during the safety preparation phase. In the expansion phase, researchers will evaluate the anti-tumor activity of the combination therapy.
The trial is structured in two parts: the safety preparation phase and the expansion phase. Researchers aim to enroll up to 107 participants, with the study expected to last approximately three years.