Syros 5609-101 (Solid Tumors) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the study drug (SY-5609) is safe and to determine the highest tolerable dose of SY-5609 in participants with select, advanced solid tumors, where standard therapies no longer work or do not exist.

What is the Condition Being Studied?

Solid tumors of interest

Who Can Participate in the Study?

Adults with cancers for which standard curative or palliative measures do not exist or are no longer working, which include:
- Metastatic or unresectable cancers, such as: breast, ovarian, lung, colorectal, or pancreatic cancer
- Any metastatic or unresectable solid tumor histology with evidence of deregulated RB cell cycle control
- Postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer

Age Group

What is Involved?

If you choose to join this study, you will:
- Take the study drug (SY-5609) by mouth OR take study drug by mouth combined with receiving injections of another drug (fulvestrant)
- Provide old tumor tissue
- Have physical exams, blood and urine tests
- Have imaging scans (CT and/or MRI)
- Have heart tests (ECG)

Study Details

Full Title
A Phase 1 Study of SY-5609, an Oral, Selective CDK7 Inhibitor, in Adult Patients With Select Advanced Solid Tumors
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00107481
NCT: NCT04247126
Phase I
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center