A Study of SY 5609, a Selective CDK7 Inhibitor, in Advanced Solid Tumors
NCT ID: NCT04247126
Last Updated: 2023-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
105 participants
INTERVENTIONAL
2020-01-23
2023-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Group 1: Single Agent Dose Escalation
Dose escalation phase to explore maximum tolerated dose of SY-5609 given as a single agent.
SY-5609
An oral CDK7 Inhibitor
Group 2: SY-5609 + Fulvestrant
Participants with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) negative advanced or metastatic breast cancer (BC) that has progressed following prior treatment with a cyclin-dependent kinase (CDK)4/6 inhibitor in combination with hormonal therapy will receive SY-5609 in combination with fulvestrant.
SY-5609
An oral CDK7 Inhibitor
Fulvestrant
Estrogen receptor antagonist
Group 3: SY-5609 + Gemcitabine
Participants with PDAC will receive SY-5609 in combination with gemcitabine in Safety Lead-in to identify a recommended combination dose for the expansion. The expansion part will assess the safety, tolerability, and preliminary clinical activity of SY-5609 in combination with gemcitabine at the recommended combination dose.
SY-5609
An oral CDK7 Inhibitor
Gemcitabine
Nucleoside metabolic inhibitor
Group 4: SY-5609 + Gemcitabine + Nab-paclitaxel
Participants with PDAC will receive SY-5609 in combination with gemcitabine plus nab-paclitaxel in Safety Lead-in to identify a recommended combination dose for the expansion. The expansion part will assess the safety, tolerability, and preliminary clinical activity of SY-5609 in combination with gemcitabine plus nab-paclitaxel at the recommended combination dose.
SY-5609
An oral CDK7 Inhibitor
Gemcitabine
Nucleoside metabolic inhibitor
Nab-paclitaxel
Taxane-type chemotherapy
Interventions
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SY-5609
An oral CDK7 Inhibitor
Fulvestrant
Estrogen receptor antagonist
Gemcitabine
Nucleoside metabolic inhibitor
Nab-paclitaxel
Taxane-type chemotherapy
Eligibility Criteria
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Inclusion Criteria
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 β 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).
Exclusion Criteria
2. 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
3. Received any other investigational agents within 4 weeks before enrollment, or \< 5 half-lives since completion of previous investigational therapy, whichever is shorter
4. 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
5. Known brain metastases or carcinomatous meningitis
6. Immunocompromised participants with increased risk of opportunistic infections
7. 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.
8. 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)
9. Female participants who are pregnant or breastfeeding
10. History of clinically significant cardiac disease or clinically relevant uncontrolled cardiac risk factors
11. Uncontrolled intercurrent illness.
12. Poorly controlled ascites requiring paracentesis within 1 month prior to entering the study. (Groups 3 and 4 only)
18 Years
ALL
No
Sponsors
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Syros Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Marineau JJ, Hamman KB, Hu S, Alnemy S, Mihalich J, Kabro A, Whitmore KM, Winter DK, Roy S, Ciblat S, Ke N, Savinainen A, Wilsily A, Malojcic G, Zahler R, Schmidt D, Bradley MJ, Waters NJ, Chuaqui C. Discovery of SY-5609: A Selective, Noncovalent Inhibitor of CDK7. J Med Chem. 2022 Jan 27;65(2):1458-1480. doi: 10.1021/acs.jmedchem.1c01171. Epub 2021 Nov 2.
Sava GP, Fan H, Coombes RC, Buluwela L, Ali S. CDK7 inhibitors as anticancer drugs. Cancer Metastasis Rev. 2020 Sep;39(3):805-823. doi: 10.1007/s10555-020-09885-8.
Other Identifiers
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SY-5609-101
Identifier Type: -
Identifier Source: org_study_id
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