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

Carrick Therapeutics Limited49 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Breast Cancer Locally Advanced Breast Cancer Breast Cancer

Interventions

SamuraciclibDRUG

Samuraciclib capsules by mouth once a day

Elacestrant DihydrochlorideDRUG

Elacestrant tablets by mouth once a day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (23)

Outcomes

Primary Outcomes

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

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

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.

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)

Secondary Outcomes

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.

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)

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.

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)

Data from ClinicalTrials.gov

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