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NCT Number: NCT05963997

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

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Cancer Breast Diseases Breast Neoplasms Locally Advanced Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Samuraciclib

Drug

Samuraciclib capsules by mouth once a day

Elacestrant Dihydrochloride

Drug

Elacestrant tablets by mouth once a day

Other names: ORSERDU

Primary outcomes

  1. Phase 1b (Dose-finding)

    Time frame: From the date of first dose of any study intervention (Day 1 Cycle 1) and through 28 days after the last dose of any study intervention

    Identification of Samuraciclib + Elacestrant combination, Phase 2, expansion dose level.

    Incidence and severity of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse events (NCI-CTCAE) v5.0. Safety will be assessed by monitoring treatment - emerged severe and dose limiting adverse events and clinically relevant changes in vital signs and clinical laboratory results

  2. Phase 2 (Expansion)

    Time frame: From the date of first dose of any study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)

    Progression Free Survival (PFS) is defined as the time from the date of first dose of IMP (Cycle 1 Day 1) to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.

Secondary outcomes

  1. Treatment-Emergent Adverse Events and Laboratory Abnormalities (Safety and Tolerability)

    Time frame: From the date of first dose of any study intervention through 28 days after the last dose of any study intervention

    Type, incidence, severity (as graded by CTCAE v5.0), seriousness and relationship to study medications of AEs and any laboratory abnormalities. Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.

  2. Clinical Benefit Response (CBR)

    Time frame: From the date of first dose of any study intervention (Cycle 1 Day 1) to ≥ 24 weeks or until disease progression or death to any cause (assessed up to week 24)

    CBR is defined as the overall complete response (CR), partial response (PR), or stable disease (SD) ≥ 24 weeks according to RECIST version 1.1 recorded from enrolment until disease progression, or death due to any cause.

  3. Overall response rate (ORR)

    Time frame: the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)

    ORR is defined as the proportion of participants with a reduction in tumor burden with CR or PR according to RECIST version 1.1.

    ORR will be estimated for participants who received at least 1 dose of IMP, had measurable disease at baseline and had a postbaseline tumor assessment.

  4. Duration of Response (DOR)

    Time frame: From the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)

    DOR is defined as the time from the date of first documentation of objective tumor response (CR or PR) to the earliest documented disease progression per RECIST version 1.1

  5. Best percent change in tumor size.

    Time frame: From the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)

    Best percent change in tumor size is defined as the percentage change in the sum of the longest diameters of target lesions

  6. Samuraciclib plasma exposure: Cmax

    Time frame: Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days)

    Plasma concentration for Samuraciclib

  7. Elacestrant exposure: Cmax

    Time frame: Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days)

    Plasma concentrations for Elacestrant

  8. Samuraciclib plasma exposure: Ctrough

    Time frame: Cycle 1 Day 2 and 15; Day 2 of Cycle 2; Day 1 of Cycles 3-6 and end of treatment within 28 days of last dose of IMP and prior to the initiation of a new anticancer therapy (each cycle is 28 days)]

  9. Elacestrant exposure: Ctrough

    Time frame: Cycle 1 Day 2 and Day 15; Cycle 2 Day 2 of Cycle 2 and Day 1 of Cycles 3-6 and at end of treatment within 28 days of the last dose of IMP and prior to the initiation of a new anticancer therapy (each cycle is 28 days)

  10. Genotyping for ESR1 and TP53 mutations

    Time frame: Screening

    Genotyping for ESR1 and TP53 mutations to evaluate correlations between ESR1 and TP53 mutations and efficacy/safety findings

Sponsors and collaborators

Lead sponsor

Carrick Therapeutics Limited

Industry

Collaborators

  • Berlin-Chemie AG Menarini Group

Registry information

Official study title

A Phase 1b/2 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

Acronym: SUMIT-ELA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2023
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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