Danish biotech company Adcendo announced on Wednesday that it has received approval from the US Food & Drug Administration (FDA) for its IND application for a Phase I study assessing ADCE-T02 in patients with advanced solid tumours.

Adcendo is conducting a first-in-human Phase I multicentre, open-label, dose escalation study of ADCE-T02, named Tiffany-01, as a monotherapy in patients with advanced solid tumours.

The primary objectives of the study are to determine the maximum tolerated dose and recommended Phase II dose and schedule of ADCE-T02 monotherapy, in addition to assessing ADCE-T02 safety and tolerability. Secondary objectives are to characterise the pharmacokinetics and to evaluate the preliminary efficacy of ADCE-T02.

The study is currently recruiting in Australia and will start recruiting in the United States in the next few months.