Adcentrx Therapeutics Receives FDA Fast Track Designation for Nectin-4 ADC in Advanced Cervical Cancer
Wednesday, May 07, 2025
Adcentrx Therapeutics has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its investigational therapy, ADRX-0706.
ADRX-0706 is a proprietary ADC created by Adcentrx using its i-Conjugation® technology platform. It combines a fully human IgG1 antibody that targets Nectin-4 with a tubulin inhibitor payload, AP052. The conjugate uses a cleavable linker and stable binding chemistry to improve delivery of the drug to tumour cells.
Advanced cervical cancer refers to cancer that has spread beyond the cervix to nearby tissues or distant organs. It typically includes stages III and IV of the disease. Common symptoms at this stage may include pelvic pain, abnormal bleeding, and fatigue. Treatment options are often limited and may involve chemotherapy, radiotherapy, or targeted therapies. The condition remains difficult to treat, especially in patients whose cancer returns or progresses after initial therapy. There is a continued need for more effective treatments for this patient population.
The treatment is intended for patients with locally advanced or metastatic squamous cell cervical cancer.
ADRX-0706 is a Nectin-4-targeting Antibody-Drug Conjugate (ADC) currently being assessed in a Phase 1b clinical study as part of an ongoing Phase 1a/b trial (NCT06036121).
Initial data suggest the therapy has a favourable safety and pharmacokinetic profile, with fewer side effects such as peripheral neuropathy. Early signs of effectiveness have also been observed in various tumour types. Nectin-4 is highly expressed in cervical cancer cells and is associated with poor outcomes, making it a relevant target for this type of therapy.
This trial involves patients with several types of advanced solid tumours, including cervical cancer.
Source: prnewswire.com
