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