Adcentrx Doses First Patient in Phase 1a/b Study of ADRX-0405 for Advanced Tumors

Adcentrx Therapeutics, a biotechnology company developing innovative protein conjugates for cancer treatment, has embarked on a new phase in its research and development efforts. The company recently dosed its first patient in a Phase 1a/b clinical study of ADRX-0405, a promising therapeutic candidate aimed at treating advanced solid tumors. This development marks a significant milestone for Adcentrx, showcasing the potential of its antibody-drug conjugate (ADC) technology.

The clinical trial, which is open-label and includes dose escalation and dose expansion phases, is being carried out across multiple sites in the United States. It aims to enroll patients with specific advanced solid tumors to assess the safety and tolerability of ADRX-0405 and identify the optimal dosage. Initial results from this study are anticipated by the fourth quarter of 2025.

ADRX-0405 represents a next-generation ADC designed to target the six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a protein predominantly expressed in prostate cancer and some other cancer types. This protein has limited expression in normal tissues, making it an attractive target for cancer therapies. The therapeutic potential of ADRX-0405 is rooted in Adcentrx's proprietary i-Conjugation® technology platform, which employs protease-cleavable linkers and stable conjugation chemistry to enhance the delivery of therapeutic payloads.

One of the key features of ADRX-0405 is its incorporation of a topoisomerase inhibitor payload, which is conjugated to an antibody at a drug-to-antibody ratio of eight (DAR 8). Preclinical studies have illustrated that ADRX-0405 possesses favorable pharmacokinetics, a strong safety profile, and significant efficacy across various tumor models, highlighting its promise as a new therapeutic option for cancer patients.

Adcentrx's commitment to advancing cancer treatment is further demonstrated through its focus on developing a comprehensive pipeline of ADCs. Besides ADRX-0405, the company is also working on ADRX-0706, a Nectin-4 targeting ADC currently in a Phase 1a/b clinical trial. These efforts underscore Adcentrx's dedication to pioneering breakthroughs in protein conjugate therapeutics for cancer and other life-threatening diseases.

As a clinical-stage biotechnology firm, Adcentrx is at the forefront of addressing critical challenges in ADC design, aiming to offer first-in-class and best-in-class therapies. The company's innovative approach leverages its i-Conjugation® technology platform, which plays a vital role in the development of more effective and targeted cancer treatments.

The study for ADRX-0405, identified as NCT06710379 on ClinicalTrials.gov, is a testament to Adcentrx's forward-thinking strategy in the field of biotechnology. Through its cutting-edge research and commitment to delivering novel cancer therapies, Adcentrx is poised to make significant contributions to the treatment landscape for patients facing serious health challenges.

With ongoing trials and a growing pipeline of promising therapeutic candidates, Adcentrx Therapeutics continues to advance the boundaries of cancer treatment, offering hope for improved outcomes for patients battling challenging diseases. The company's innovative work in protein conjugate therapeutics highlights its role as a leader in the biotechnology sector, dedicated to transforming the future of cancer care.