IND Required for ITC-6146RO for Solid Tumors Overexpressing the B7-H3 Protein

On August 29, 2025, a clinical trial plan (Investigational New Drug application) was submitted to the Ministry of Food and Drug Safety (MFDS) of South Korea to initiate phase 1 clinical trials for ITC-6146RO. ITC-6146RO is an antibody-drug conjugate (ADC) designed to target solid tumors overexpressing the B7-H3 protein, such as metastatic castration-resistant prostate cancer […]

OMNIRAY: a Phase 1 Clinical Trial for LY4257496 for mCRPC

The OMNIRAY trial will be investigating LY4257496, a novel radioligand therapy and it is set to begin in August 2025. This phase 1a/1b, multicenter, open-label study aims to establish the safety, tolerability and dosimetry of LY4257496 in adult patients bearing advanced solid tumors that express the gastrin-releasing peptide receptor (GRPR). The trial proposes a two-part […]

Update: HLD-0915 Advances with FDA Fast Track Designation for Metastatic Castration-Resistant Prostate Cancer