This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination with abemaciclib (VERZENIO®) in participants with advanced estrogen-receptor positive, human epidermal growth factor receptor-2 negative (ER+/HER2-) breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
ZN-c5 is the study drug.
Abemaciclib (VERZENIO®) is an approved drug.
Site 2
Gilbert, Arizona, United States
Site 1
Charleston, South Carolina, United States
Site 6
Grudziądz, Poland
Site 4
Krakow, Poland
Site 5
Lodz, Poland
Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib
Measured by the number of treatment-emergent adverse events and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Time frame: Through study completion, anticipated to be 21 months
Determine tumor responses to combination treatment
Measured by radiographic responses as defined by revised Response Evaluation Criteria in Solid Tumor (RECIST) v1.1.
Time frame: Through study completion, anticipated to be 21 months
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