Kintara Therapeutics has activated the first European site of the VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) registrational Phase II/III clinical trial for treating glioblastoma (GBM).
The first site in Europe was launched at University Hospital Zurich in Switzerland.
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Named GBM AGILE, the trial is underway at 44 clinical centres in the US and Canada.
The global, patient-centred, adaptive platform trial is assessing various therapies for recently diagnosed and recurrent GBM patients.
Carried out under a master protocol, the trial will permit simultaneous analyses of various therapies, or combinations of treatments, from different pharmaceutical companies.
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GCAR intends to enrol nearly 150 to 200 subjects in the Kintara arm of the trial at more than 40 centres in the US and Canada. This could be expanded to a total of 65 sites globally.
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By GlobalDataA small-molecule chemotherapeutic of the company, VAL-083 has a new mechanism of action.
In the National Cancer Institute (NCI)-sponsored trials in the US, the therapy showed clinical activity against various cancers, including the central nervous system, ovarian and other solid tumours.
Based on Kintara’s in-house research programmes and prior trials, the company will advance VAL-083 in the GBM AGILE trial to back the therapy’s development and marketing for GBM treatment.
With its new design and operational infrastructure, GBM AGILE trial findings could be used as the basis for seeking a new drug application and biologics license application as well as registrations to the FDA and other health agencies.
Kintara president and CEO Robert Hoffman said: “We continue to see an accelerated pace for which our treatment arm is being executed in the study.
“We are also observing GCAR’s exceptional clinical trial execution capabilities, which were among the aspects that drew us to participate in this highly efficient registrational study.”
