A Phase Ib/II Open-label Study of Samuraciclib in Combination With Elacestrant in Participants With Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer

Study Identifier:
CT7001-003
CT.gov Identifier:
NCT05963997
EudraCT Identifier:
2023-000072-35
EU Trial (CTIS) Number:
2023-503846-30-00
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

Considering participating in a START clinical trial?

Get Started

Study Summary

To confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer. To evaluate the novel combination of Carrick’s samuraciclib (CT7001), an oral and first-in-class inhibitor of CDK7, and Menarini‘s oral selective estrogen receptor degrader (SERD), elacestrant, in patients with CDK4/6i resistant HR+, HER2- metastatic breast cancer. All patients will undergobaseline Guardant360 ctDNA analysis to establish their ESR-1 and TP53-mutation status.Patients will undergo RECIST v1.1 evaluation at baseline every 8-weeks until week 48,followed by every 12-weeks thereafter.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Breast Cancers
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Cohort 1
    • Read More
  • Drug: Drug: Elacestrant Dihydrochloride
  • Drug: Experimental: Cohort 2
  • Drug: Experimental: Cohort 3
  • Drug: Experimental: Cohort 4 Expansion
  • Drug: All patients will undergo baseline Guardant360 ctDNA analysis to establish their ESR-1 and TP53-mutation status. Patients will undergo RECIST v1.1 evaluation at baseline every 8-weeks until week 48, followed by every 12-weeks thereafter. Initially both samuraciclib and elacestrant will be administered once daily in a dose escalation/de-escalation approach under supervision of the study Safety Review Committee.
  • Drug: Subject have received an AI + CDK4/6i in the adjuvant or advanced
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    Inclusion criteria
    • Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer.
    • Documented objective disease progression while on or within 6 months after the end of the most recent therapy.
    • Received prior AI in combination with a CDK4/6i as the last therapy
    • Known TP53 and ESR1 mutation status.
    • Participants must have measurable disease or bone only disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
    • Pre/peri-menopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of study intervention.
    • Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no deterioration over the past 2 weeks.
    • Expected life expectancy of >12 weeks in the judgement of the treating investigator.
    • patients willprovide written informed consent, be aged 18 years or older, have histologically or cytologicallyconfirmed ER+/HER2- advanced or metastatic breast cancer not amenable to resection orradiotherapy of curative intent, have received an aromatase inhibitor in combination with aCDK4/6 inhibitor in either the adjuvant or advanced setting, be receiving a luteinizing hormone-releasing hormone agonist if pre/perimenopausal and have RECIST v1.1 evaluable disease.Prior SERD, mammalian target of rapamycin inhibitor (mTORi) or chemotherapy for advancedbreast cancer are not permitted.
    Exclusion criteria
    • Inflammatory breast cancer.
    • Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
    • More than 1 line of endocrine treatment for locally advanced or metastatic disease treatment.
    • Inadequate hepatic, renal, and bone marrow function.
    • Clinically significant cardiovascular disease.
    • Any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
    • Pregnant or breastfeeding women.

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers