On December 2, 2024 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company advancing innovative protein conjugates for cancer and other life-threatening diseases, reported the dosing of the first patient in the Phase 1b portion of ADRX-0706-001, the ongoing Phase 1a/b study of ADRX-0706 for the treatment of advanced solid tumors (Press release, Adcentrx Therapeutics, DEC 2, 2024, View Source [SID1234648710]).
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"We are pleased to advance the clinical development of ADRX-0706 into the Phase 1b dose expansion cohorts," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "Encouraging findings from our Phase 1a trial demonstrate the best-in-class potential for ADRX-0706, with differentiated safety and pharmacokinetic properties, including a much lower incidence of critically meaningful AEs for patients, such as peripheral neuropathy. Additionally, the preliminary efficacy responses observed across different dose levels and tumor types provide important clinical validation of Adcentrx’s ADC platform, including the i-Conjugation technology and novel auristatin payload AP052."
The first-in-human Phase 1a/b study is an open-label, two-part trial being conducted at sites in the U.S. and China. The Phase 1a part consisted of a dose escalation of ADRX-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in the Phase 1b part. This second portion of the study will continue to assess the safety and tolerability of ADRX-0706, as well as evaluate preliminary efficacy and determine the optimal dose in urothelial cancer, triple-negative breast cancer, and cervical cancer expansion cohorts. The company expects an initial data readout from the Phase 1b in 4Q 2025.
About ADRX-0706
ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component is a novel fully human IgG1 targeting Nectin-4, a cell surface adhesion protein with high expression in multiple solid tumors and limited expression in normal tissues. Nectin-4 is associated with poor disease prognosis and is a validated target for ADCs.
The ADRX-0706 antibody is linked to a proprietary tubulin inhibitor payload, AP052, through Adcentrx’s innovative i-Conjugation technology using a cleavable linker and stable conjugation chemistry. This novel platform technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded therapeutic window as demonstrated in preclinical studies.
ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo. ADRX-0706 is currently being evaluated in a Phase 1a/b clinical trial.
For more information about the ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on ClinicalTrials.gov.