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A Study of SY 5609, a Selective CDK7 Inhibitor, in Advanced Solid Tumors

Cancer Type
Breast Cancer
Trial Phase
Phase I
18 Years and older, Male and Female
Study Type
Protocol IDs
SY-5609-101 (primary)
Study Sponsor
Syros Pharmaceuticals


The study consists of 2 parts. Part 1 is dose escalation and will first administer SY-5609
alone to participants with select advanced solid tumors and then in combination with
fulvestrant to participants with HR positive, HER2-negative breast cancer. Part 2 is a dose
expansion and will first administer SY-5609 in combination with gemcitabine and then SY-5609
in combination with gemcitabine and nab-paclitaxel in participants with pancreatic ductal
adenocarcinoma (PDAC) .


  1. Age = 18 years
  2. Advanced Solid Tumors for which standard curative or palliative measures do not exist or are no longer effective (Group 1 only).
  3. Postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer. Participants must have failed prior treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor in combination with hormonal therapy in a previous line of therapy (Group 2 only).
  4. Participants with histologically or cytologically confirmed PDAC with measurable metastatic lesion(s) (Groups 3 and 4 only).
  5. Participants must have at least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  6. All toxicities (except alopecia) from prior cancer treatments must have resolved to = Grade 1 before enrollment.
  7. For women of childbearing potential (WCBP): negative serum ß human chorionic gonadotropin pregnancy test within 1 week before the first dose of SY 5609
  8. Adequate organ and marrow function
  9. Participants must be willing and able to comply with all aspects of the protocol
  10. Participants must provide written informed consent before any study-specific screening procedures.
  11. Albumin = 3.0 grams/deciliters (g/dL) (Groups 3 and 4 only).
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Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.