A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants (SUMIT-BC)

Carrick Therapeutics

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Samuraciclib; Drug: Fulvestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05963984

CT7001_002

Z0041001 (Other Identifier)

2023-503903-27-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of samuraciclib in combination with fulvestrant versus fulvestrant alone in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.

Enrollment: 60 estimated 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 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Arm A

Experimental group

Description:

Participants will receive 360 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15.

Treatment:

Drug: Fulvestrant

Drug: Samuraciclib

Arm B

Experimental group

Description:

Participants will receive 240 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15.

Treatment:

Drug: Fulvestrant

Drug: Samuraciclib

Arm C

Experimental group

Description:

Participants will receive fulvestrant administered monthly, plus additional dose at Cycle 1 Day 15.

Treatment:

Drug: Fulvestrant