Avacta Group has dosed the first patient in the US in the dose-escalation portion of its Phase I trial of AVA6000 to treat patients with locally advanced and/or metastatic solid tumours that are known to be FAP-positive.
The patient was dosed at the Memorial Sloan Kettering Cancer Center in New York.
The Phase I first-in-human (FIH), open-label, multicentre, dose-escalation study will evaluate the safety, tolerability, pharmacokinetics (PK) and early efficacy of AVA6000 monotherapy given intravenously (IV) to the targeted patients.
It will be carried out in two parts, Phase Ia dose escalation and Phase Ib dose expansion.
During Phase Ia, the safety, tolerability and maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of AVA6000, administered as monotherapy will be examined.
Phase Ib will include one to three expansion arms in specific tumour types to investigate the safety and tolerability of AVA6000 at the MTD or RP2D when given as monotherapy.
The Phase I trial aims to enrol 80 subjects, with plan to complete it by 30 June 2023.
AVA6000 is a tumour targeted form of doxorubicin and represents Avacta’s first therapeutic product developed using its proprietary pre|CISION technology.
Avacta Group CEO Dr Alastair Smith said: “The US trial sites in New York and Seattle will play a key role, along with other sites in the UK and US, in this multi-centre trial both in the dose escalation phase and in the dose expansion phase which we expect to begin in the second half of the year.”