A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer
NCT04514159 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2023-02-01
Summary
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.
Conditions
Interventions
- DRUG
-
ZN-c5
ZN-c5 is the study drug.
- DRUG
-
Abemaciclib (VERZENIO®) is an approved drug.
Sponsors & Collaborators
-
Zeno Alpha Inc.
lead INDUSTRY
Principal Investigators
-
Carrie Brownstein, MD · Zeno Alpha Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-12
- Primary Completion
- 2022-10-24
- Completion
- 2022-10-24
- FDA Drug
- Yes
Countries
- United States
- Poland
Study Locations
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