Metastatic Breast CancerPhase 1/2SUMIT-ELANCT05963997
A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer
A Phase 1/2 study testing Samuraciclib and Elacestrant Dihydrochloride in people with Metastatic Breast Cancer and Locally Advanced Breast Cancer, run by Carrick Therapeutics Limited at 23 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer
- What is being tested?
- Samuraciclib and Elacestrant Dihydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 9 Oct 2023to 6 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
Spain10 sites
Site 65 - Complexo Hospitalario Universitario A Coruña
A Coruña
Site 64 - Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona
Site 68 -Hospital Universitario Vall d'Hebron
Barcelona
Site 61 - Institut Catala d'Oncologia (ICO), Hospital Duran i Reynals Location
L'Hospitalet de Llobregat
Site 62 - Universidad de Navarra, Clinica Universidad de Navarra (CUN)
Madrid
Site 63 - South Texas Accelerated Research Therapeutics, CIOCC, Hospital Madrid Norte-Sanchinarro
Madrid
Site 66 - Hospital Clinico San Carlos
Madrid
Site 69 - Universidad de Navarra - Clinica Universidad de Navarra (CUN)
Pamplona
Site 60 - NEXT Oncology EU Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcón
Site 67 - Universidad de Sevilla, Hospital Universitario Virgen Macarena
Seville
United States5 sites
Site 42 - Dana-Farber Cancer Institute, EDDC
Boston, Massachusetts, 02215
Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University
Chicago, Illinois, 60611
Site 35 - Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio, 44106
Site 41 - The START Center for Cancer Care, South Texas Oncology and Hematology
San Antonio, Texas, 78229
Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus
Seattle, Washington, 98122
France5 sites
Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie
Bordeaux
Site 80 - Centre Jean Bernard, Clinique Victor Hugo
Le Mans
Site 83 - Institut Paoli Calmettes (IPC)
Marseille
Site 85 - Institut Curie
Paris
Site 82 - Institut de Cancerologie de Ouest (ICO)
Saint-Herblain
United Kingdom3 sites
Site 12 - Belfast City Hospital
Belfast
Site 4 - The Christie NHS Foundation Trust
Manchester
Site 2 - Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, OX3 7LE
About this study
Official 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
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.
Read the 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.
- Being tested
- Samuraciclib, Elacestrant Dihydrochloride
- Keywords
- Metastatic Breast Cancer, Advanced Breast Cancer, Breast Cancer, HR Positive, HER2-Negative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamuraciclibDrug
Samuraciclib capsules by mouth once a day
Elacestrant DihydrochlorideDrug
Also called ORSERDU
Elacestrant tablets by mouth once a day
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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). Receives: Drug: Samuraciclib; Drug: Elacestrant Dihydrochloride |
| Cohort 2 | Experimental | 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). Receives: Drug: Samuraciclib; Drug: Elacestrant Dihydrochloride |
| Cohort 3 | Experimental | 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). Receives: Drug: Samuraciclib; Drug: Elacestrant Dihydrochloride |
| Cohort 4 Expansion | Experimental | 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). Receives: Drug: Samuraciclib; Drug: Elacestrant Dihydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b (Dose-finding)
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
Measured: 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)
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.
Measured: 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 outcomes (10)
Treatment-Emergent Adverse Events and Laboratory Abnormalities (Safety and Tolerability)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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
Measured: 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.
Best percent change in tumor size is defined as the percentage change in the sum of the longest diameters of target lesions
Measured: 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
Plasma concentration for Samuraciclib
Measured: Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days)
Elacestrant exposure: Cmax
Plasma concentrations for Elacestrant
Measured: Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days)
Samuraciclib plasma exposure: Ctrough
Measured: 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
Measured: 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
Genotyping for ESR1 and TP53 mutations to evaluate correlations between ESR1 and TP53 mutations and efficacy/safety findings
Measured: Screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start9 Oct 2023
- Primary completion6 Mar 2026
- Study completion6 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carrick Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Berlin-Chemie AG Menarini Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963997
- Sponsor's protocol ID
- CT7001_003
- Other IDs
- 2023-503846-30-00, 2023-000072-35, 2023
- Acronym
- SUMIT-ELA
- Status last verified
- Mar 2026
- First submitted
- 30 Jun 2023
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05963997
- Acronym / sponsor ID
- SUMIT-ELA / CT7001_003
- Keywords
- Metastatic Breast Cancer, Advanced Breast Cancer, Breast Cancer, HR Positive, HER2-Negative
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Carrick Therapeutics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Berlin-Chemie AG Menarini Group
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Samuraciclib, Drug: Elacestrant DihydrochlorideUp 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). |
| Cohort 2 | Experimental | Drug: Samuraciclib, Drug: Elacestrant DihydrochlorideUp 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). |
| Cohort 3 | Experimental | Drug: Samuraciclib, Drug: Elacestrant DihydrochlorideUp 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). |
| Cohort 4 Expansion | Experimental | Drug: Samuraciclib, Drug: Elacestrant DihydrochlorideUp 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SamuraciclibSamuraciclib capsules by mouth once a day | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 Expansion |
| Elacestrant DihydrochlorideAlso: ORSERDUElacestrant tablets by mouth once a day | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 Expansion |
Primary outcome
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
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.
10 secondary outcomes
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
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)
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)
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)
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)
Samuraciclib plasma exposure: Cmax
Time frame: 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)
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)]
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)
Genotyping for ESR1 and TP53 mutations
Time frame: Screening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Samuraciclib and Elacestrant Dihydrochloride in people with Metastatic Breast Cancer and Locally Advanced Breast Cancer, run by Carrick Therapeutics Limited at 23 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Spain, United States, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.