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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05963997
Other study ID # CT7001_003
Secondary ID 2023-503846-30-0
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 9, 2023
Est. completion date June 16, 2025

Study information

Verified date May 2024
Source Carrick Therapeutics Limited
Contact Clinical Operations
Phone +353 1 5996873
Email hello@carricktherapeutics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date June 16, 2025
Est. primary completion date December 23, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
Samuraciclib
Samuraciclib capsules by mouth once a day
Elacestrant Dihydrochloride
Elacestrant tablets by mouth once a day

Locations

Country Name City State
France Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie Bordeaux
France Site 80 - Centre Jean Bernard, Clinique Victor Hugo Le Mans
France Site 84 - UNICANCER, Centre Leon-Berard (CLB) Lyon
France Site 83 - Institut Paoli Calmettes (IPC) Marseille
France Site 85 - Institut Curie Paris
France Site 82 - Institut de Cancerologie de Ouest (ICO) Saint-Herblain
Spain Site 65 - Complexo Hospitalario Universitario A Coruña A Coruña
Spain Site 64 - Hospital Clinic de Barcelona (Hospital Clinic i Provincial) Barcelona
Spain Site 68 -Hospital Universitario Vall d'Hebron Barcelona
Spain Site 61 - Institut Catala d'Oncologia (ICO), Hospital Duran i Reynals Location L'Hospitalet De Llobregat
Spain Site 62 - Universidad de Navarra, Clinica Universidad de Navarra (CUN) Madrid
Spain Site 63 - South Texas Accelerated Research Therapeutics, CIOCC, Hospital Madrid Norte-Sanchinarro Madrid
Spain Site 66 - Hospital Clinico San Carlos Madrid
Spain Site 69 - Universidad de Navarra - Clinica Universidad de Navarra (CUN) Pamplona
Spain Site 60 - NEXT Oncology EU Hospital Universitario Quiron Salud Madrid Pozuelo de Alarcon
Spain Site 67 - Universidad de Sevilla, Hospital Universitario Virgen Macarena Sevilla
United Kingdom Site 12 - Belfast City Hospital Belfast
United Kingdom Site 4 - The Christie NHS Foundation Trust Manchester
United Kingdom Site 13 - Nottingham City Hospital Nottingham
United Kingdom Site 2 - Oxford University Hospitals NHS Trust - Churchill Hospital Oxford
United States Site 40 - Massachusetts General Hospital Boston Massachusetts
United States Site 42 - Dana-Farber Cancer Institute, EDDC Boston Massachusetts
United States Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University Chicago Illinois
United States Site 35 - Cleveland Clinic, Taussig Cancer Institute Cleveland Ohio
United States Site 43 - Mid Florida Hematology and Oncology Center Orange City Florida
United States Site 41 - The START Center for Cancer Care, South Texas Oncology and Hematology San Antonio Texas
United States Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Carrick Therapeutics Limited Berlin-Chemie AG Menarini Group

Countries where clinical trial is conducted

United States,  France,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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
Primary 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. 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 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. From the date of first dose of any study intervention through 28 days after the last dose of any study intervention
Secondary 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. 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)
Secondary 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.
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)
Secondary 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 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)
Secondary 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 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)
Secondary Samuraciclib plasma exposure: Cmax Plasma concentration for Samuraciclib Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days)
Secondary Elacestrant exposure: Cmax Plasma concentrations for Elacestrant Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days)
Secondary Samuraciclib plasma exposure: Ctrough 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)]
Secondary Elacestrant exposure: Ctrough 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)
Secondary Genotyping for ESR1 and TP53 mutations Genotyping for ESR1 and TP53 mutations to evaluate correlations between ESR1 and TP53 mutations and efficacy/safety findings Screening
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