Phase 1 Clinical Trial for ADRX-0405 in Advanced Solid Tumors Including Prostate Cancer
A Phase 1 clinical trial for an innovative drug candidate, ADRX-0405, started last week. This trial underscores the potential of an antibody-drug conjugate (ADC) technology platform in advancing cancer treatment.
ADRX-0405 is designed to target STEAP1 (six-transmembrane epithelial antigen of the prostate 1), a cell surface protein highly expressed in prostate cancer and certain other cancers. Its limited expression in normal healthy tissues makes it an attractive therapeutic target.
With a DAR of 8, ADRX-0405 ensures a high drug payload per antibody for enhanced efficacy. Preclinical models have shown favorable pharmacokinetics, safety, and significant efficacy in multiple tumor models.
The study is a first-in-human, open-label clinical trial conducted in two parts: dose escalation and dose expansion. It is taking place at multiple sites across the United States.
Initial results from the trial are anticipated in the fourth quarter of 2025.