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).
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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.