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

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ClinicalTrials.gov Identifier: NCT04247126
Recruitment Status : Recruiting
First Posted : January 29, 2020
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Syros Pharmaceuticals

Study Description
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Brief Summary:
This is a dose escalation study and will be the first to administer SY-5609 alone to humans with select advanced solid tumors and in combination with Fulvestrant to patients with HR positive, HER2-negative breast cancer.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Breast Cancer Small-cell Lung Cancer Drug: SY-5609 Drug: Fulvestrant Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of SY 5609, an Oral, Selective CDK7 Inhibitor, in Adult Patients With Select Advanced Solid Tumors
Actual Study Start Date : January 23, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Fulvestrant

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Agent Dose Escalation
Dose escalation phase to explore maximum tolerated dose of SY-5609 given as a single agent.
 Drug: SY-5609
An oral CDK7 Inhibitor
Experimental: SY-5609 + Fulvestrant
Patients 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.
 Drug: SY-5609
An oral CDK7 Inhibitor

Drug: Fulvestrant
estrogen receptor antagonist


Outcome Measures
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Primary Outcome Measures :
  1. Single Agent Dose Limiting Toxicity [ Time Frame: Through Study Completion, an average of one year ]
  2. Single Agent Incidence of Adverse Events [ Time Frame: Through Study Completion, an average of one year ]
  3. Changes in Hematologic Lab Values from Baseline [ Time Frame: Through Study Completion, an average of one year ]
    Number of Patients with Effects on Laboratory Parameters

  4. Changes in Chemistry Lab Values from Baseline [ Time Frame: Through Study Completion, an average of one year ]
    Number of Patients with Effects on Laboratory Parameters

  5. Changes in Coagulation Values from Baseline [ Time Frame: Through Study Completion, an average of one year ]
    Number of Patients with Effects on Laboratory Parameters

  6. Changes in Urinalysis Values from Baseline [ Time Frame: Through Study Completion, an average of one year ]
    Number of Patients with Effects on Laboratory Parameters

  7. Changes in Electrocardiograms (ECGs) [ Time Frame: Through Study Completion, an average of one year ]
    QT Interval

  8. Body Temperature [ Time Frame: Through Study Completion, an average of one year ]
    Celcius

  9. Blood Pressure [ Time Frame: Through Study Completion, an average of one year ]
    mm/hg

  10. Heart Rate [ Time Frame: Through Study Completion, an average of one year ]
    Beats per Minute

  11. Respiratory Rate [ Time Frame: Through Study Completion, an average of one year ]
    Breaths per Minute


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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. Patients must have failed prior treatment with a CDK 4/6 inhibitor in combination with hormonal therapy in a previous line of therapy (Group 2 only).
  4. Patients must have at least one (1) measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  5. All toxicities (except alopecia) from prior cancer treatments must have resolved to ≤ Grade 1 before enrollment.
  6. For women of childbearing potential (WCBP): negative serum β human chorionic gonadotropin pregnancy test within 1 week before the first dose of SY 5609
  7. Adequate organ and marrow function
  8. Patients must be willing and able to comply with all aspects of the protocol
  9. Patients must provide written informed consent before any study-specific screening procedures

Exclusion Criteria:

  1. Chemotherapy or limited field radiotherapy within two (2) weeks, wide field radiotherapy within four (4) weeks, or nitrosoureas or mitomycin C within six (6) weeks before entering the study
  2. Major surgery within two (2) weeks before starting the study treatment, or not recovered to baseline status from the effects of surgery received > two (2) weeks prior
  3. Received any other investigational agents within 4 weeks before enrollment, or < five (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 two (2) weeks, or < five (5) half-lives since completion of previous therapy, whichever is shorter
  5. Known brain metastases or carcinomatous meningitis
  6. Immunocompromised patients with increased risk of opportunistic infections
  7. Patients with known active or chronic hepatitis B or active hepatitis C infection. Patients 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 ms

    • NOTE: criterion does not apply to patients with a right or left bundle branch block (QTc interval)
  9. Female patients who are pregnant or breastfeeding
  10. History of clinically significant cardiac disease or clinically relevant uncontrolled cardiac risk factors
  11. Uncontrolled intercurrent illness
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04247126


Contacts
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Contact: Kimberley Caliri 617-674-9053 kcaliri@syros.com
Contact: Tiffany Crowell 617-674-9069 tcrowell@syros.com

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rachel Annese       RANNESE2@mgh.harvard.edu   
Principal Investigator: Dejan Juric, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Amanda Fiorentino       Amandam_fiorentino@dfci.harvard.edu   
Principal Investigator: Geoffrey Shapiro, MD         
United States, Michigan
START Midwest, LLC Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Shannon Skibinski-Preston    616-954-5552    shannon.skibinski@startmidwest.com   
Principal Investigator: Manish Sharma, MD         
United States, Oklahoma
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Dana Low       Dana-Low@ouhsc.edu   
Principal Investigator: Debra Richardson, MD         
United States, Pennsylvania
Sidney Kimmel Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Allison Scott       Allison.Scott@jefferson.edu   
Principal Investigator: Babar Bashir, MD         
United States, Tennessee
Sarah Cannon Research Institute - Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Jacquelyn Spence    615-340-2830    jacquelyn.spence@sarahcannon.com   
Principal Investigator: Erika Hamilton, MD         
United States, Texas
South Texas Accelerated Research Theraputics (START), LLC Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez, RN, MSN    210-593-5265    isabel.jimenez@startsa.com   
Principal Investigator: Kyriakos Papadopoulos, MD         
Sponsors and Collaborators
Syros Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Syros Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04247126    
Other Study ID Numbers: SY-5609-101
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Small Cell Lung Carcinoma
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
 Respiratory Tract Diseases
Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs