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

Completed · Phase 1

Conditions studied: Advanced Solid Tumor, Breast Cancer, Small-cell Lung Cancer, Pancreatic Cancer

In brief

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) .

Key facts

Study ID

NCT04247126

Run by

Syros Pharmaceuticals

People needed

105

Starts

2020-01-23

Expected to finish

2023-03-30

Last updated by the study team

2023-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Advanced Solid Tumors for which standard curative or palliative measures do not exist or are no longer effective (Group 1 only).
• 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).
• Participants with histologically or cytologically confirmed PDAC with measurable metastatic lesion(s) (Groups 3 and 4 only).
• Participants must have at least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• All toxicities (except alopecia) from prior cancer treatments must have resolved to ≤ Grade 1 before enrollment.
• For women of childbearing potential (WCBP): negative serum β human chorionic gonadotropin pregnancy test within 1 week before the first dose of SY 5609
• Adequate organ and marrow function
• Participants must be willing and able to comply with all aspects of the protocol
• Participants must provide written informed consent before any study-specific screening procedures.
• Albumin ≥ 3.0 grams/deciliters (g/dL) (Groups 3 and 4 only).

You may not qualify if…

• Chemotherapy or limited field radiotherapy within 2 weeks, wide field radiotherapy within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks before entering the study
• Major surgery within 2 weeks before starting the study treatment, or not recovered to baseline status from the effects of surgery received > 2 weeks prior
• Received any other investigational agents within 4 weeks before enrollment, or < 5 half-lives since completion of previous investigational therapy, whichever is shorter
• Received previous noncytotoxic, US Food and Drug Administration-approved anticancer agent within previous 2 weeks, or < 5 half-lives since completion of previous therapy, whichever is shorter
• Known brain metastases or carcinomatous meningitis
• Immunocompromised participants with increased risk of opportunistic infections
• Participants with known active or chronic hepatitis B or active hepatitis C infection. Participants with a history of hepatitis C virus (HCV) infection who have completed curative therapy for HCV at least 12 weeks before Screening and have a documented undetectable viral load at Screening are eligible for enrollment.
• Baseline QT interval corrected (QTc) with Fridericia's method > 480 milliseconds
• NOTE: criterion does not apply to participants with a right or left bundle branch block (QTc interval)
• Female participants who are pregnant or breastfeeding
• History of clinically significant cardiac disease or clinically relevant uncontrolled cardiac risk factors
• Uncontrolled intercurrent illness.
• Poorly controlled ascites requiring paracentesis within 1 month prior to entering the study. (Groups 3 and 4 only)

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Orlando Health Cancer Institute — Orlando, Florida, United States
• Emory University — Atlanta, Georgia, United States
• The University of Iowa — Iowa City, Iowa, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• START Midwest, LLC — Grand Rapids, Michigan, United States
• Duke University — Durham, North Carolina, United States
• Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute - Tennessee Oncology — Nashville, Tennessee, United States
• South Texas Accelerated Research Theraputics (START), LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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