GI Innovation has entered into a clinical supply agreement with Johnson & Johnson to evaluate a novel combination therapy for patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) in a Phase Ib clinical trial.

The study will assess the safety and therapeutic potential of combining GI Innovation’s immuno-oncology candidate GI-102 with pasritamig (KLK2-CD3), a first-in-class bispecific T-cell engager developed by Johnson & Johnson. The trial targets mCRPC, an advanced stage of prostate cancer with limited treatment options and significant unmet medical need.

Under the agreement, Johnson & Johnson will supply pasritamig for the trial, while GI Innovation will act as the study sponsor. The clinical trial will be conducted across sites in South Korea and the United States.

The study will be led globally by Mark Stein of Columbia University Irving Medical Centre as the coordinating investigator. In South Korea, major tertiary care institutions including Asan Medical Centre and Severance Hospital will participate in the trial.

The collaboration reflects growing interest in combination approaches in immuno-oncology, particularly involving T-cell engager technologies designed to enhance the immune system’s ability to target cancer cells.

GI Innovation noted that the partnership is expected to help validate the clinical potential of its GI-102 candidate and strengthen its platform through collaboration with global pharmaceutical players.

The trial represents a strategic step in advancing next-generation cancer therapies aimed at improving outcomes in difficult-to-treat malignancies such as mCRPC.