First Patient Enrolled in Phase 1 Clinical Trial of SY-1365 in Breast, Other Solid Cancers

First Patient Enrolled in Phase 1 Clinical Trial of SY-1365 in Breast, Other Solid Cancers
Syros Pharmaceuticals has enrolled the first patient in a Phase 1 clinical trial assessing the effectiveness and safety of SY-1365 as a treatment for patients with advanced solid tumors, such as triple-negative breast cancer, small-cell lung cancer, and ovarian cancer. SY-1365 is a first-in-class selective inhibitor of a protein called cyclin-dependent kinase 7 (CDK7) that helps solid-tumor cancers survive. CDK7 is known as a transcription factor protein because it controls the expression of other proteins. The usual definition of expression is that it's the process by which information from a gene is used to create a functional product like a protein. Cancers that transcription factors impact are known as transcriptionally dependent cancers. “SY-1365 represents a promising new approach for treating a number of aggressive cancers that have eluded treatment with other targeted approaches,” Dr. Anthony W. Tolcher, the trial investigator, said in a news release. “Certain cancers are particularly dependent on high expression of transcription factors for their growth and survival, and SY-1365 has shown substantial anti-tumor activity in preclinical models of these cancers. We’re pleased to have enrolled the first patient in this clinical trial and look forward to further investigating SY-1365 for patients with these difficult-to-treat solid tumors.” The trial (NCT03134638) is expected to include about 70 patients with advanced solid tumors. The two-part, dose-escalation study will assess the safety and tolerability of increasing doses of SY-1365. The objective is to identify the optimal dose for a Phase 2 study that will further assess the therapy's effectiveness. The dose-escalation stage of the study is open to patients who would be unable to
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