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    Association details:
    Biomarker:HR positive
    Cancer:Hormone Receptor Positive Breast Cancer
    Drug:samuraciclib (CT7001) (CDK7 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO 2021
    Title:

    265P - Study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in combination with fulvestrant in patients with advanced hormone receptor positive HER2 negative breast cancer (HR+BC)

    Published date:
    09/13/2021
    Excerpt:
    31 patients with HR+BC received the combination of standard dose with fulvestrant and samuraciclib….RECIST evaluation indicates evidence of reduction in tumor disease burden, including a partial response in one patient who has been on treatment for ∼ 1 year....Samuraciclib has demonstrated an acceptable safety profile with evidence of anti-tumour activity in combination with fulvestrant for patients with advanced HR+BC...
    Secondary therapy:
    fulvestrant
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO 2021
    Title:

    230MO - First in human, modular study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in patients with advanced solid malignancies

    Published date:
    09/13/2021
    Excerpt:
    Tolerability, pharmacokinetics and efficacy of samuraciclib were assessed; including evaluation of ascending doses (M1A), paired tumour biopsy (PB) samples (M1A), effect of food on bioavailability (M4) and a triple-negative breast cancer (TNBC) expansion cohort (M1B). 57% (25/44) of RECIST evaluable patients had evidence of disease control at first post baseline scan (FPBS) observed across the ‘all comer’ cohorts in M1A and M4, including a partial response (PR) in a patient with HR+ breast cancer.
    Trial ID:
    2017-002026-20
    Evidence Level:
    Sensitive: C4 – Case Studies
    Source:
    Nat Commun
    Title:

    Dose escalation and expansion cohorts in patients with advanced breast cancer in a Phase I study of the CDK7-inhibitor samuraciclib

    Published date:
    07/24/2023
    Excerpt:
    Module 2A explored the safety, tolerability and preliminary efficacy of 2 dose levels of samuraciclib (240 mg OD and 360 mg OD) in combination with fulvestrant in HR+/HER2− advanced breast cancer patients who had previously received CDK4/6 inhibitor therapy....A heavily pre-treated patient with HR+ breast cancer receiving samuraciclib monotherapy 240 mg OD achieved a partial response (PR) sustained for over 24 weeks.
    Secondary therapy:
    fulvestrant
    DOI:
    https://doi.org/10.1038/s41467-023-40061-y