ADC Therapeutics, an oncology drug discovery and development company that specialises in the development of proprietary antibody drug conjugates, has dosed its first patient in its Phase one clinical trial assessing the safety, tolerability, pharmacokinetics and anti-tumour activity of ADCT-601 in patients with selected solid tumours that are locally advanced or metastatic, it was reported on Friday.
The product is an antibody drug conjugates composed of a humanised monoclonal antibody against human AXL, conjugated using GlycoConnect site specific conjugation technology to a pyrrolobenzodiazepine (PBD) dimer toxin. In preclinical studies, ADCT-601 demonstrated potent and specific in vitro and in vivo anti-tumour activity in multiple cancer-derived models with different levels of AXL expression, and was stable and well tolerated.
The open-label, multicentre, single-arm trial will include a Phase Ia dose-escalation part followed by a Phase Ib dose-expansion part. The dose-escalation part is intended to determine the maximum tolerated dose of ADCT-601. The identified dose will be assessed in the dose-expansion part. Around 75 patients will be enrolled in the trial.
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