Volastra Therapeutics has announced the dosing of the first subject in a Phase Ib clinical trial of sovilnesib for patients with platinum-resistant or refractory high-grade serous ovarian cancer (HGSOC).
The study aims to determine the recommended Phase II dose (RP2D) of a once-a-day oral dosage of sovilnesib in HGSOC patients through a dose optimisation process.
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It will employ an adaptive multi-cohort design to evaluate the tolerability, safety, pharmacokinetics, and efficacy of sovilnesib at various dose levels.
The study is structured in two parts, with part one involving ten subjects per dose level to collect preliminary data.
Part two will expand the cohort to 20 to 30 additional subjects across selected dose levels from part one to finalise the RP2D.
Sovilnesib has obtained fast track designation from the US Food and Drug Administration. The designation was awarded based on promising initial clinical data and the significant need for new treatments in this patient population.
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By GlobalDataIt was in-licensed by Volastra from Amgen in February last year.
Volastra focuses on developing therapies targeting chromosomal instability, including two clinical-stage KIF18A inhibitors, VLS-1488, and sovilnesib.
In addition to the trial of sovilnesib, Volastra is advancing VLS-1488 in an ongoing Phase I trial.
The company is also focusing on biomarker development to predict responses to KIF18A inhibitors, collaborating with industry leaders, such as Microsoft, Tailor Bio, and Function Oncology.
Volastra CEO Charles Hugh-Jones said: “Advancing our two chemically differentiated KIF18A inhibitors in parallel Phase 1 clinical trials presents the rare opportunity to efficiently gather comparative clinical data.
“We believe our strategy will allow us to select the first, and potentially best-in-class, medicine for patients to advance to late-stage development for the treatment of platinum-resistant or refractory HGSOC.”
