GI Innovation has applied for a combination therapy investigational new drug (IND) for metastatic castration-resistant prostate cancer (mCRPC) in Korea and the United States.
The company said on the 19th that it submitted a phase 1b/2 clinical trial plan for the combination of the immuno-oncology drug "GI-102" and the T-cell engager "pasritamig (KLK2-CD3)" to the Ministery of Food and Drug Safety and the U.S. Food and Drug Administration (FDA).
The trial will enroll mCRPC patients who failed novel hormonal therapy (NHT). The goal is to evaluate the antitumor activity, safety, and tolerability of the GI-102 and pasritamig combination.
The trial will proceed in a safety assessment stage and an expansion stage. In the initial stage, it will set the maximum tolerated dose (MTD) or the recommended phase 2 dose and assess safety and tolerability. The expansion stage will then confirm antitumor activity.
The study will run concurrently in Korea and the United States. In Korea, Severance Hospital and Asan Medical Center will participate, and in the United States, Columbia University Irving Medical Center will participate. The total number of subjects will be up to 107, and the study period is expected to be about three years.
The trial will be conducted based on a clinical collaboration and supply agreement between GI Innovation and Janssen R&D, a Johnson & Johnson (J&J) subsidiary.
A company official said, "on the 17th, we signed a clinical supply agreement with Janssen R&D for patients with metastatic castration-resistant prostate cancer (mCRPC)," and noted, "accordingly, Janssen will supply pasritamig to GI Innovation free of charge."