Switzerland-based Basilea Pharmaceutica has dosed the first patient in the Phase lla expansion part of a Phase l/lla clinical trial evaluating safety, tolerability and efficacy of BAL101553 to treat recurrent glioblastoma and patients with platinum-resistant or refractory ovarian cancer.
The single-agent, open-label, Phase lla trial expects to enrol up to 40 patients and will be carried out in various hospitals within Switzerland.
Primary endpoint of the trial is maximum tolerated dose (MTD) of BAL101553 based on the number of participants with adverse effects as a measure of tolerability at various dose levels within 28-day treatment cycles.
The trial’s secondary endpoints include safety and tolerability, bioavailability and anti-tumour activity of BAL101553, among others.
Basilea Pharmaceutica chief medical officer Dr Marc Engelhardt said: “The start of the Phase lla expansion study marks a significant milestone towards establishing clinical proof-of-concept for our biomarker-driven development strategy with our novel tumour checkpoint controller BAL101553.
“There are only very limited treatment options available for patients with recurrent glioblastoma and for patients with platinum-resistant or platinum-refractory ovarian cancer.
“Our decision to explore the potential clinical benefit in these specific patient populations is based on the results from our Phase l studies and our comprehensive non-clinical profiling.”
In January this year, Basilea announced the completion of the dose-escalation phase in two Phase l/lla studies of BAL101553 in advanced solid tumours.
As part of the trials, the patients were treated with a once-daily oral and weekly 48-hour intravenous (i.v.) administration of BAL101553 as a single-agent therapy.
The trials established the maximum tolerated doses for these dosing regimens of BAL101553 in solid tumour patients.