A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: ZN-c5 + abemaciclib combination therapy Participants will take abemaciclib (150mg) orally twice a day and ZN-c5 (dose escalation) orally once or twice a day to determine the safety, tolerability, and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D). |
Drug: ZN-c5
ZN-c5 is the study drug.
Drug: Abemaciclib
Abemaciclib (VERZENIO®) is an approved drug.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib [Through study completion, anticipated to be 21 months]
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
Secondary Outcome Measures
- Determine tumor responses to combination treatment [Through study completion, anticipated to be 21 months]
Measured by radiographic responses as defined by revised Response Evaluation Criteria in Solid Tumor (RECIST) v1.1.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years of age
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Women can be peri- or postmenopausal, as defined by at least one of the following:
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Age ≥ 60 years;
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Age < 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle-stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females;
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Documented bilateral oophorectomy;
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Must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks prior to the first dose of study medication
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Histologically or cytologically confirmed diagnosis of advanced adenocarcinoma of the breast
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Estrogen receptor positive disease
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Human Epidermal Growth Factor Receptor 2 negative disease
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Measurable disease per Response Evaluation Criteria in Solid Tumors v1.1
Exclusion Criteria:
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Prior therapy within the following windows:
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Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy < 14 days;
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Any investigational drug therapy < 28 days or 5 half-lives (whichever is shorter)
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Any prior systemic chemotherapy regardless of the stop date, but the subject must have recovered to eligibility levels from prior toxicity
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Prior treatment with CDK4/6 inhibitors
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Unexplained symptomatic endometrial disorders (including, but not limited to, endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Site 2 | Gilbert | Arizona | United States | 85234 |
2 | Site 1 | Charleston | South Carolina | United States | 29414 |
3 | Site 6 | Grudziądz | Poland | 86-300 | |
4 | Site 4 | Kraków | Poland | 30-348 | |
5 | Site 5 | Łódź | Poland | 93-513 |
Sponsors and Collaborators
- Zeno Alpha Inc.
Investigators
- Study Director: Andrew Henry, Zeno Alpha Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZN-c5-003