Sapience Therapeutics has announced plans to carry out a sub-study of its Phase I-II clinical trial of ST101 underway in recurrent and newly diagnosed patients with glioblastoma (GBM).
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.
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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.
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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.
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By GlobalDataThe company will carry out the sub-study in partnership with principal investigators from Northwestern University and Columbia University.
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.”
