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.
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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.
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By GlobalData“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.
