Alentis Therapeutics has dosed the first subject in a Phase I/II clinical trial of its investigational antibody, ALE.C04, to treat patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

The multicentre, open-label, first-in-human trial is designed to evaluate ALE.C04 as a monotherapy and along with pembrolizumab in 220 adult patients.

Safety, pharmacokinetics, anti-tumour efficacy and tolerability are the endpoints of the trial.

The first patient was enrolled at the University of Southern California (USC) Norris Comprehensive Cancer Center, which is part of USC’s Keck Medicine.

A monoclonal antibody, ALE.C04 acts on exposed CLDN1 on cancer cells. It can potentially treat cancer by destroying tumour cells through the effector function, and extracellular matrix remodelling, which causes enhanced trafficking of NK and T-cells.

The US Food and Drug Administration (FDA) granted fast track designation for ALE.C04 to treat CLDN1+ HNSCC.

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Alentis chief medical officer Luigi Manenti said: “ALE.C04 is a first-in-class antibody for treating cancer and has shown much potential in preclinical models. 

“ALE.C04 is designed to kill CLDN1+ tumour cells directly and to break the check-point inhibitor treatment resistance by restoring immune cell trafficking.”

Established in 2019, Alentis focuses on the development of therapies for CLDN1+ tumours and organ fibrosis. 

In July this year, the company dosed the first subject in Phase Ib FEGATO-01 clinical trial of antibody, ALE.F02, to treat liver, kidney, and lung fibrosis.