Metastatic Breast Cancer MedDRA version: 20.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: HLT Classification code 10006289 Term: Benign and malignant bre
Conditions
Interventions
Trade Name: Lerociclib
Product Name: Lerociclib
Product Code: EQ132, G1T38
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Lerociclib
CAS Number: 2096938-59-3
Other descriptive name: EQ13
Sponsors
EQRx, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Is capable of giving signed informed consent. This includes compliance with the requirements and restrictions listed in the study informed consent form (ICF) and in this protocol. 2. Must be at least 18 years of age, or the legal age of consent in the jurisdiction in which the study is taking place, at the time of giving signed informed consent. Type of Participant and Disease Characteristics 3. Has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor-positive breast cancer by local laboratory. 4. Breast cancer is also HER2-negative and advanced (locoregionally recurrent; not amenable to curative therapy, eg, surgery and/or radiotherapy; or metastatic) and meets one of the following criteria: • Newly diagnosed advanced/metastatic breast cancer, treatment-naïve. • Relapsed with documented evidence of relapse following neoadjuvant (adjuvant) endocrine therapy, with no treatment for advanced/metastatic disease. • Relapsed with documented evidence of relapse following completion of adjuvant endocrine therapy, then subsequently progressed with documented evidence of progression after one (1) line of endocrine therapy (with either tamoxifen or an AI) for advanced/metastatic disease. • Newly diagnosed advanced/metastatic breast cancer at diagnosis that progressed with documented evidence of progression after one (1) line of endocrine therapy (with either tamoxifen, exemestane, or an AI [other than fulvestrant]). 5. Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 or 1. 6. Has adequate bone marrow and organ function, as defined by all of the following laboratory values: • Absolute neutrophil count (ANC) = 1.5 × 109/L • Platelets = 100 × 109/L • Hemoglobin = 9.0 g/dL • International normalized ratio (INR) = 1.5 • Creatinine clearance (CLcr) = 60/mL, as estimated by Cockcroft-Gault equation • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) below 2.5 × upper limit of normal (ULN) • Total bilirubin = 1.5 × ULN; OR, for participants with well-documented Gilbert’s Syndrome, direct bilirubin within normal range of the central laboratory 7. Baseline QTc interval is =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions 1. Has symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy, per the Investigator’s best judgment. 2. Has peritoneal carcinomatosis. 3. Has inflammatory breast cancer at Screening. 4. Has central nervous system (CNS) involvement, unless participant is at least 4 weeks from prior therapy completion to starting study treatment, has stable CNS tumor at the time of Screening, and is not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases. 5. Has any clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality. 6. Has a history of prolonged QT syndrome or Torsades de Pointes. Prior/Concomitant Therapy 7. Has received prior treatment with chemotherapy (except neoadjuvant/adjuvant chemotherapy), or with any CDK4/6 inhibitor. 8. Has received prior treatment with fulvestrant. 9. Use of systemic estrogens (eg, hormonal contraception, hormone replacement therapy [HRT]). 10. Is currently receiving any of the following substances and cannot be discontinued 14 days prior to starting lerociclib: • Known strong or moderate CYP3A inducers or strong inhibitors of CYP3A • Substances that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5 Diagnostic Assessments 11. Ejection fraction of = 45% on echocardiogram performed within the past 12 months, or documented history of congestive heart failure with reduced ejection fraction. 12. Oral temperature of > 38°C at Screening, or any evidence of SARS-CoV-2 infection. 13. Interstitial pneumonia or severe impairment of lung function, with the latter defined as having vital capacity AND diffusing capacity of the lung for carbon monoxide (DLCO) that are = 50% of the normal predicted values OR having an oxygen (O2) saturation at rest in ambient environment of = 88%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the safety and tolerability of lerociclib in combination with endocrine therapy in participants with 1L and 2L HR+/HER2- mBC.;Secondary Objective: • To investigate the efficacy of lerociclib in combination with endocrine therapy in participants with 1L and 2L HR+/HER2- mBC by line of therapy. • To further characterize the safety and tolerability of lerociclib in combination with endocrine therapy in participants with 1L and 2L HR+/HER2- mBC. • To assess change from baseline in global health status and qualify of life (QoL) in participants with 1L and 2L HR+/HER2- mBC by line of therapy • To characterize the pharmacokinetic (PK) profile of lerociclib in combination with endocrine therapy in partipcants with 1L and 2L HR+/HER2- mBC ;Primary end point(s): Incidence of adverse events (AEs) and serious adverse events (SAEs);Timepoint(s) of evaluation of this end point: The primary analysis will occur approximately 6 months after the last participant receives the first dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Objective response rate (ORR), defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) as assessed by Investigator • Clinical benefit rate (CBR), defined as the proportion of participants with a best overall response of CR, PR, or stable disease (SD) (for at least 8 weeks) according to RECIST v1.1 as assessed by Investigator • Progression-free survival (PFS), defined as the time from first dose of lerociclib until the date of documented progression of disease (PD) or death, according to RECIST v1.1 as assessed by Investigator • Overall survival (OS), defined as the time from the date of first dose of lerociclib to the date of death due to any cause • Duration of response (DOR), defined as the time from the date of first documented response until the date of confirmed PD or death, according to RECIST v1.1 as assessed by Investigator • Time to response (TTR), defined as the time from first dose of lerociclib until the first documented response (CR or PR) • Change from baseline in clinical laboratory parameters (hematology, clinical chemistry, coagulation, fasting lipid panel, and urinalysis) • Change from baseline in vital signs and 12 lead electrocardiogram (ECG) parameters • Clinically significant findings on physical examination ;Timepoint(s) of evaluation of this end point: For time-point(s) see section E.5.1 | — |
Countries
Belgium, Georgia, Italy, Mexico, Moldova, Republic of, Ukraine, United States
Contacts
Public ContactClinical Operations
EQRx, Inc.
Outcome results
None listed