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

Carrick Therapeutics

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Breast Cancer; Locally Advanced Breast Cancer; Metastatic Breast Cancer

Treatments: Drug: Elacestrant Dihydrochloride; Drug: Samuraciclib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05963997

2023-503846-30-00 (Registry Identifier)

CT7001_003

2023-000072-35 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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49 participants in 4 patient groups

Cohort 1

Experimental group

Description:

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).

Treatment:

Drug: Samuraciclib

Drug: Elacestrant Dihydrochloride

Cohort 2

Experimental group

Description:

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).

Treatment:

Drug: Samuraciclib

Drug: Elacestrant Dihydrochloride

Cohort 3

Experimental group

Description:

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).

Treatment:

Drug: Samuraciclib

Drug: Elacestrant Dihydrochloride

Cohort 4 Expansion

Experimental group

Description:

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).

Treatment:

Drug: Samuraciclib

Drug: Elacestrant Dihydrochloride