A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer

Last updated: May 7, 2025
Sponsor: Carrick Therapeutics Limited
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Breast Cancer

Cancer

Metastatic Cancer

Treatment

Samuraciclib

Elacestrant Dihydrochloride

Clinical Study ID

NCT05963997
CT7001_003
2023-000072-35
2023-503846-30-00
  • Ages > 18
  • All Genders

Study Summary

This is an international, multisite, open-label, Phase 1b/2 study, 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced ormetastatic breast cancer.

  • Documented objective disease progression while on or within 6 months after the endof 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 byResponse Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  • Pre/peri-menopausal participants must have commenced treatment with a luteinizinghormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose ofstudy intervention.

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with nodeterioration over the past 2 weeks.

  • Expected life expectancy of >12 weeks in the judgement of the treating investigator.

Exclusion

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 carcinomain situ of the cervix.

  • More than 1 line of endocrine treatment for locally advanced or metastatic diseasetreatment.

  • Inadequate hepatic, renal, and bone marrow function.

  • Clinically significant cardiovascular disease.

  • Any current or prior central nervous system metastases, carcinomatous meningitis, orleptomeningeal disease.

  • Pregnant or breastfeeding women.

Study Design

Total Participants: 49
Treatment Group(s): 2
Primary Treatment: Samuraciclib
Phase: 1/2
Study Start date:
October 09, 2023
Estimated Completion Date:
December 23, 2025

Study Description

This is a multiple cohort study, an initial dose escalation phase is designed to confirm the safe dose of samuraciclib in combination with elacestrant. A Safety Review Committee (SRC) will monitor the safety, tolerability, and PK data during this phase. Once ascertained, an expansion cohort will be opened to explore the efficacy of samuraciclib in combination with elacestrant.

Connect with a study center

  • Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie

    Bordeaux,
    France

    Site Not Available

  • Site 80 - Centre Jean Bernard, Clinique Victor Hugo

    Le Mans,
    France

    Site Not Available

  • Site 84 - UNICANCER, Centre Leon-Berard (CLB)

    Lyon,
    France

    Site Not Available

  • Site 83 - Institut Paoli Calmettes (IPC)

    Marseille,
    France

    Site Not Available

  • Site 85 - Institut Curie

    Paris,
    France

    Site Not Available

  • Site 82 - Institut de Cancerologie de Ouest (ICO)

    Saint-Herblain,
    France

    Site Not Available

  • Site 65 - Complexo Hospitalario Universitario A Coruña

    A Coruña,
    Spain

    Site Not Available

  • Site 64 - Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

    Barcelona,
    Spain

    Site Not Available

  • Site 68 -Hospital Universitario Vall d'Hebron

    Barcelona,
    Spain

    Site Not Available

  • Site 61 - Institut Catala d'Oncologia (ICO), Hospital Duran i Reynals Location

    L'Hospitalet De Llobregat,
    Spain

    Site Not Available

  • Site 62 - Universidad de Navarra, Clinica Universidad de Navarra (CUN)

    Madrid,
    Spain

    Site Not Available

  • Site 63 - South Texas Accelerated Research Therapeutics, CIOCC, Hospital Madrid Norte-Sanchinarro

    Madrid,
    Spain

    Site Not Available

  • Site 66 - Hospital Clinico San Carlos

    Madrid,
    Spain

    Site Not Available

  • Site 69 - Universidad de Navarra - Clinica Universidad de Navarra (CUN)

    Pamplona,
    Spain

    Site Not Available

  • Site 60 - NEXT Oncology EU Hospital Universitario Quiron Salud Madrid

    Pozuelo de Alarcon,
    Spain

    Site Not Available

  • Site 67 - Universidad de Sevilla, Hospital Universitario Virgen Macarena

    Sevilla,
    Spain

    Site Not Available

  • Site 12 - Belfast City Hospital

    Belfast,
    United Kingdom

    Site Not Available

  • Site 4 - The Christie NHS Foundation Trust

    Manchester,
    United Kingdom

    Site Not Available

  • Site 13 - Nottingham City Hospital

    Nottingham,
    United Kingdom

    Site Not Available

  • Site 2 - Oxford University Hospitals NHS Trust - Churchill Hospital

    Oxford, OX3 7LE
    United Kingdom

    Site Not Available

  • Site 43 - Mid Florida Hematology and Oncology Center

    Orange City, Florida 32763
    United States

    Site Not Available

  • Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Site 40 - Massachusetts General Hospital

    Boston, Massachusetts 02114-2696
    United States

    Site Not Available

  • Site 42 - Dana-Farber Cancer Institute, EDDC

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Site 35 - Cleveland Clinic, Taussig Cancer Institute

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Site 34 -The University of Texas, MD Anderson Cancer Center, Nellie B. Connally Breast Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Site 41 - The START Center for Cancer Care, South Texas Oncology and Hematology

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus

    Seattle, Washington 98122
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.