US-based biopharmaceutical company Syros Pharmaceuticals has started dosing patients in its Phase I clinical trial of SY-1365 for the treatment of patients with advanced solid tumours.

SY-1365 is a selective inhibitor of cyclin-dependent kinase 7 (CDK7).

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Designed to recruit a total of 70 patients, the multicentre, open-label Phase I trial will include expansion cohorts for patients with transcriptionally dependent cancers such as triple negative breast, small cell lung and ovarian cancers.

While the dose-escalation phase will evaluate increasing doses of SY-1365, the expansion cohorts will assess its safety and anti-tumour activity.

Syros chief medical officer David Roth said: “Patients with triple negative breast, small cell lung and ovarian cancers, as well as other transcriptionally dependent cancers, are in dire need of better treatment options.

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"Based on the strong preclinical data, we believe SY-1365 could provide a meaningful benefit for patients with these cancers."

“Based on the strong preclinical data, we believe SY-1365 could provide a meaningful benefit for patients with these cancers.

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“We have designed our Phase I trial to efficiently assess early proof of mechanism during the dose escalation phase and early anti-tumour activity by focusing the expansion phase of the trial on a set of transcriptionally dependent tumours that are most sensitive to CDK7 inhibition, and for which early anti-tumour activity may be observed.”

The trial’s primary objective is to determine the safety, tolerability, maximum tolerated dose and recommended Phase II dose and regimen of SY-1365.

Based on the results from this trial, the firm intends to further study SY-1365 as a potential treatment for acute leukaemia.