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

Status
Completed
Cancer Type
Breast Cancer
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04247126
Protocol IDs
SY-5609-101 (primary)
NCI-2020-03935
Study Sponsor
Syros Pharmaceuticals

Summary

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) .

Eligibility

  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).
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.