The trial’s Phase I dose-escalation stage is being carried out across various sites in the US. Credit: National Cancer Institute on Unsplash.

Sapience Therapeutics has dosed the first patient in the ST316-101 Phase I-II trial of its ST316 antagonist of β-catenin for the treatment of advanced solid tumours.

The first-in-human, open-label, dose-escalation and expansion trial aims to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and early efficacy of ST316.

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Its Phase I dose-escalation stage will examine multiple dose levels of ST316 in patients with select advanced solid tumours that usually harbour the Wnt/β-catenin signalling pathway abnormalities.

This portion, which is being carried out across various sites in the US, is anticipated to be completed in the second half of next year.

Upon completion of this portion, Sapience will advance the recommended dose to the Phase II portion of the trial.

In Phase II, ST316 will be investigated in four advanced solid tumour types.

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ST316 can selectively target the Wnt/β-catenin signalling pathway’s oncogenic activation, without affecting its activity in normal cells.

Sapience Therapeutics chief medical officer Dr Abi Vainstein-Haras said: “Dosing our first patient with ST316 is a significant accomplishment for our team, which has remained undaunted by the challenge of drugging one of the most challenging cancer targets, the Wnt/β-catenin pathway.

“We are thrilled to advance our second molecule from the bench to the clinic. Given the relevance of Wnt/β-catenin in the development of multiple cancers, we are excited about ST316’s potential to make a meaningful difference for the many patients suffering from cancers driven by abnormalities in this pathway.”

This March, Sapience secured IND approval from the US Food and Drug Administration (FDA) to commence a Phase I-II trial of ST316 to treat solid tumours.