SHR-4394: Phase 1/2 Trial Explores PSMA-Targeted ADC Combination Therapies in Prostate Cancer

A Phase 1/2 clinical trial (NCT07407283) is investigating SHR-4394, a novel PSMA-targeted antibody-drug conjugate (ADC), in combination with other anticancer treatments for patients with advanced prostate cancer.

SHR-4394 is designed to recognize prostate-specific membrane antigen (PSMA), a protein commonly expressed on prostate cancer cells, and deliver a cytotoxic payload directly to the tumor. Unlike PSMA-targeted radioligand therapies, which use radioactive isotopes, this ADC uses a chemotherapy-based approach.

The study explores SHR-4394 in combination with three different agents: rezvilutamide, an androgen receptor inhibitor; HRS-5041, an investigational androgen receptor degrader; and tazemetostat, an inhibitor of EZH2, an enzyme involved in epigenetic regulation of gene expression.

These combinations investigate different ways of attacking prostate cancer, including androgen receptor signaling and epigenetic mechanisms. The rationale is to determine whether combining PSMA-directed drug delivery with other anticancer approaches can provide additional activity.

Clinical trial.