U.S. FDA grants orphan drug designation to Adcentrx Therapeutics’ ADRX-0405 STEAP1 ADC for gastric cancer

CAR-T Digest - August 2020

08 July 2025: U.S. FDA grants orphan drug designation to Adcentrx Therapeutics’ ADRX-0405 STEAP1 ADC for gastric cancer

The U.S. FDA granted orphan drug designation to Adcentrx Therapeutics ADC candidate ADRX-0405 for the treatment of gastric cancer
ADRX-0405 is a STEAP1-targeting ADC currently in Phase 1a trials for multiple solid tumors, including prostate, gastric, and non-small cell lung cancers
The progress of Phase 1a trial is postive and look forward to further evaluating the safety, tolerability and anti-tumor activity of ADRX-0405 in gastric and other cancers