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

• Status: Recruiting
• Trial end date: 2025-06-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.