Back

A Phase 1 Study of SY 5609, an Oral, Selective CDK7 Inhibitor, in Adult Patients With Select Advanced Solid Tumors

A Phase 1 Study of SY 5609, an Oral, Selective CDK7 Inhibitor, in Adult Patients With Select Advanced Solid Tumors

  • Clinical Trial Information

    Trial Contact: Grofsik, Kiera; Donaldson, Karin M; Frankos, Marie

  • IRB No: 21.112.07

    Protocol Abbrev: SY-5609-101

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase I

    Age Group: Adult

    Secondary Protocol No: SY-5609-101

    Treatment: SY-5609 Fulvestrant

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT04247126

  • Objective

    Primary Objectives:

    •   Determine the safety, tolerability, and MTD of SY-5609 as a single agent (Group 1)

    Secondary Objectives
    •   Characterize the PK of SY-5609
    •   Characterize the safety and tolerability of SY-5609 in combination with fulvestrant (Group 2)

    Exploratory Objectives
    •   Evaluate the pharmacodynamic effects of SY-5609 in blood and tissues
    •   Evaluate the preliminary antitumor activity of SY-5609 in patients with select advanced solid tumor
    malignancies
    SY-5609 Dated 10 December 2020
    Clinical Study Protocol SY-5609-101 Amendment 5.0
    Syros Pharmaceuticals, Inc. Confidential Page 8 of 78
    •   Evaluate the preliminary antitumor activity of SY-5609 + fulvestrant in patients with HR-positive,
    HER2-negative advanced or metastatic breast cancer
    •   Identify candidate biomarkers predictive of response to SY-5609

  • Key Eligibility

    Patients may be eligible for inclusion in the study if they meet the following criteria:

    1. Age ≥ 18 years
    2. Diseases for which standard curative or palliative measures do not exist or are no longer effective, including:
    Patients Enrolled into Single-Agent SY-5609 Dose Escalation (Group 1)
    •   Histologically confirmed metastatic or unresectable breast, ovarian (including fallopian tube and primary peritoneal), lung, colorectal, and pancreatic (pancreatic ductal adenocarcinoma) cancers, or
    •   Any metastatic or unresectable solid tumor histology with evidence of deregulated RB cell cycle control (mutation or homozygous deletion of RB1, CDKN1A, or CDKN2A, or focal high-level amplification of CCNE1, CCND1, CCND2, CDK4, or CDK6) based on available molecular test results and after Sponsor review to confirm eligibility