BerGenBio has dosed the first patient in a Phase I clinical trial assessing the safety, tolerability, pharmacokinetics and anti-tumour efficacy of ADCT-601 for the treatment of patients with advanced solid tumours.
The open-label, multi-centre, single-arm trial will see BerGenBio enrol around 75 patients with selected tumour types.
BerGenBio license partner ADC Therapeutics will manage and sponsor the trial, which includes a dose-escalation phase followed by a dose-expansion phase.
The trial features a screening period of up to 28 days, a treatment period of three weeks cycle, and a follow-up period of up to two years after the discontinuation of the study drug treatment.
Primary objectives of the trial are dose-limiting toxicity and maximum tolerated dose.
The trial’s secondary objectives comprise overall response rate (ORR), disease control rate (DCR), duration of response (DOR), and overall survival (OS).
BerGenBio CEO Richard Godfrey said: “Our focus remains on completing our ongoing oncology Phase II programme with bemcentinib, a first-in-class highly selective oral AXL inhibitor, and start randomised, potentially pivotal trials later this year.
“In the meantime, we look forward to providing updates on the development of BGB149, a therapeutic AXL antibody, and ADCT-601, an anti-AXL ADC, as they progress through Phase I testing.”
BerGenBio’s ADCT-601 drug contains BGB601, a humanised monoclonal antibody that binds to human AXL.