On January 6, 2025 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company advancing innovative protein conjugates for cancer and other life-threatening diseases, reported the first patient dosed in the Phase 1a/b study of ADRX-0405 for the treatment of advanced solid tumors (Press release, Adcentrx Therapeutics, JAN 6, 2025, View Source [SID1234649421]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Advancing our second program into clinical trials marks an important milestone for Adcentrx and further validates the potential of our ADC technology platform," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "STEAP1 is an attractive ADC target, and we are excited about the first-in-class potential for ADRX-0405. We believe this novel ADC offers a unique approach to treating patients with STEAP1-expressing cancers, such as metastatic castration-resistant prostate cancer, where a significant unmet need remains for new targeted therapies."

The first-in-human Phase 1a/b clinical trial of ADRX-0405 is an open-label dose escalation and dose expansion study being conducted across sites in the U.S. The trial is enrolling patients with select advanced solid tumors, with the primary objectives of characterizing the safety and tolerability of ADRX-0405 and determining its optimal dose. The company anticipates an initial data readout in 4Q 2025.

About ADRX-0405

ADRX-0405 is a next-generation antibody-drug conjugate (ADC) composed of a humanized IgG1 antibody targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers, yet has limited expression in normal healthy tissue.

Adcentrx’s proprietary i-Conjugation technology platform is an important component in the design of ADRX-0405. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with a topoisomerase inhibitor payload conjugated at a drug-to-antibody ratio of eight (DAR 8). ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple tumor models.

For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on ClinicalTrials.gov.