Manufacturers: Adcentrx Therapeutics
ADRX-0405 is an investigational first-in-class STEAP1-targeting antibody-drug conjugate (ADC) developed by Adcentrx Therapeutics, utilizing the i-Conjugation platform with a topoisomerase inhibitor payload and DAR 8. It is in Phase 1a/1b clinical development for advanced solid tumors including mCRPC, gastric cancer, and NSCLC. Received FDA orphan drug designation for gastric cancer (July 2025) and NMPA IND clearance (June 2026).
ADRX-0405 is an investigational first-in-class STEAP1-targeting antibody-drug conjugate (ADC) developed by Adcentrx Therapeutics, utilizing the i-Conjugation platform with a topoisomerase inhibitor payload and DAR 8. It is in Phase 1a/1b clinical development for advanced solid tumors including mCRPC, gastric cancer, and NSCLC. Received FDA orphan drug designation for gastric cancer (July 2025) and NMPA IND clearance (June 2026).
ADRX-0405 is an antibody-drug conjugate targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein overexpressed in prostate cancer and certain other malignancies with limited expression in healthy tissue. The ADC is composed of a humanized IgG1 antibody coupled with a novel topoisomerase inhibitor linker-payload through Adcentrx's i-Conjugation technology platform. The platform utilizes a cleavable linker and stable conjugation chemistry to enhance payload delivery, enabling a highly stable ADC with a drug-antibody ratio of eight (DAR 8) to maximize payload delivery to solid tumors.
ADRX-0405 is being evaluated in a Phase 1a/1b open-label, multicenter dose escalation and dose expansion study (NCT06710379) for patients with select advanced solid tumors, including metastatic castration-resistant prostate cancer (mCRPC), gastric cancer, and non-small cell lung cancer (NSCLC). The Phase 1a portion is expected to complete by Q4 2026. The FDA granted orphan drug designation for gastric cancer in July 2025.
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