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

February 21, 2024 updated by: Carrick Therapeutics Limited

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie
      • Le Mans, France
        • Recruiting
        • Site 80 - Centre Jean Bernard, Clinique Victor Hugo
      • Lyon, France
        • Not yet recruiting
        • Site 84 - UNICANCER, Centre Leon-Berard (CLB)
      • Marseille, France
        • Recruiting
        • Site 83 - Institut Paoli Calmettes (IPC)
      • Paris, France
        • Recruiting
        • Site 85 - Institut Curie
      • Saint-Herblain, France
        • Recruiting
        • Site 82 - Institut de Cancerologie de Ouest (ICO)
  • Spain
      • A Coruña, Spain
        • Recruiting
        • Site 65 - Complexo Hospitalario Universitario A Coruña
      • Barcelona, Spain
        • Recruiting
        • Site 64 - Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
      • Barcelona, Spain
        • Recruiting
        • Site 68 -Hospital Universitario Vall d'Hebron
      • L'Hospitalet De Llobregat, Spain
        • Recruiting
        • Site 61 - Institut Catala d'Oncologia (ICO), Hospital Duran i Reynals Location
      • Madrid, Spain
        • Recruiting
        • Site 62 - Universidad de Navarra, Clinica Universidad de Navarra (CUN)
      • Madrid, Spain
        • Recruiting
        • Site 63 - South Texas Accelerated Research Therapeutics, CIOCC, Hospital Madrid Norte-Sanchinarro
      • Madrid, Spain
        • Recruiting
        • Site 66 - Hospital Clinico San Carlos
      • Pamplona, Spain
        • Recruiting
        • Site 69 - Universidad de Navarra - Clinica Universidad de Navarra (CUN)
      • Pozuelo de Alarcon, Spain
        • Recruiting
        • Site 60 - NEXT Oncology EU Hospital Universitario Quiron Salud Madrid
      • Sevilla, Spain
        • Recruiting
        • Site 67 - Universidad de Sevilla, Hospital Universitario Virgen Macarena
  • United Kingdom
      • Belfast, United Kingdom
        • Not yet recruiting
        • Site 12 - Belfast City Hospital
      • Manchester, United Kingdom
        • Recruiting
        • Site 4 - The Christie NHS Foundation Trust
      • Nottingham, United Kingdom
        • Withdrawn
        • Site 13 - Nottingham City Hospital
      • Oxford, United Kingdom, OX3 7LE
        • Recruiting
        • Site 2 - Oxford University Hospitals NHS Trust - Churchill Hospital
  • United States
    • Florida
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Site 43 - Mid Florida Hematology and Oncology Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114-2696
        • Not yet recruiting
        • Site 40 - Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Site 42 - Dana-Farber Cancer Institute, EDDC
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Site 35 - Cleveland Clinic, Taussig Cancer Institute
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Site 41 - The START Center for Cancer Care, South Texas Oncology and Hematology
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Up to 6 evaluable participants will receive samuraciclib 240 mg in combination with elacestrant 300 mg in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards).
Drug: Samuraciclib
Samuraciclib capsules by mouth once a day
Drug: Elacestrant Dihydrochloride
Elacestrant tablets by mouth once a day
Other Names:
  • ORSERDU
Experimental: Cohort 2
Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 300 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).
Drug: Samuraciclib
Samuraciclib capsules by mouth once a day
Drug: Elacestrant Dihydrochloride
Elacestrant tablets by mouth once a day
Other Names:
  • ORSERDU
Experimental: Cohort 3
Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).
Drug: Samuraciclib
Samuraciclib capsules by mouth once a day
Drug: Elacestrant Dihydrochloride
Elacestrant tablets by mouth once a day
Other Names:
  • ORSERDU
Experimental: Cohort 4 Expansion
Up to 30 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).
Drug: Samuraciclib
Samuraciclib capsules by mouth once a day
Drug: Elacestrant Dihydrochloride
Elacestrant tablets by mouth once a day
Other Names:
  • ORSERDU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of first dose of any study intervention through 28 days after the last dose of any study intervention
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.
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)
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.
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)
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
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.
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
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)
Samuraciclib plasma exposure: Cmax
Time Frame: Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days)
Plasma concentration for Samuraciclib
Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days)
Elacestrant exposure: Cmax
Time Frame: Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days)
Plasma concentrations for Elacestrant
Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days)
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)]
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)]
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)
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)
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
Screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carrick Therapeutics Limited

Collaborators

Berlin-Chemie AG Menarini Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2023

Primary Completion (Estimated)

December 23, 2024

Study Completion (Estimated)

June 16, 2025

Study Registration Dates

First Submitted

June 30, 2023

First Submitted That Met QC Criteria

July 19, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT7001_003
  • 2023-503846-30-00 (Registry Identifier: EU CTIS)
  • 2023-000072-35 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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