The multicentre, open-label surgical sub-study of the trial will analyse the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and proof-of-concept efficacy of ST101.
It will enrol a total of 18 subjects with recurrent as well as newly diagnosed GBM.
Assessing the safety and tolerability of ST101 as a single agent in recurrent GBM patients following resection as well as in newly diagnosed GBM patients plus radiation ± temozolomide following resection are the primary objectives of the trial.
Determining ST101’s penetration in the brain and its link with plasma levels are the secondary objectives of the trial.
Subjects in both trial arms will be resected after administering two to four doses of ST101 and will continue to receive the therapy after the surgical procedure.
The principal investigator at Columbia University has received partial funding for the sub-study under a research award from the Ben and Catherine Ivy Foundation.
A C/EBPβ antagonist, ST101 has a dual mechanism of action.
It is also being analysed in a Phase II portion of Phase I-II trial in advanced unresectable and metastatic solid tumour patients.
Sapience chief medical officer Alice Bexon said: “We remain very pleased with ST101’s clinical profile and we look forward to evaluating ST101 in the surgical sub-study announced today.
“The data generated from this study, if positive, will provide early safety and efficacy signs that would allow us to advance ST101 into a first-line therapeutic option for GBM, which would be transformative for this patient population.”