Description:
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.
Title
- Brief Title: A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer
- Official Title: A Phase 1b Study of ZN-c5 in Combination With Abemaciclib in Patients With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
ZN-c5-003
- NCT ID:
NCT04514159
Conditions
Interventions
Drug | Synonyms | Arms |
---|
ZN-c5 | | ZN-c5 + abemaciclib combination therapy |
Abemaciclib | VERZENIO® | ZN-c5 + abemaciclib combination therapy |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
ZN-c5 + abemaciclib combination therapy | Experimental | 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). | |
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years of age
- Women can be peri- or postmenopausal, as defined by at least one of the following:
- Age ≥ 60 years;
- 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;
- Documented bilateral oophorectomy;
- Must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks
prior to the first dose of study medication
- Histologically or cytologically confirmed diagnosis of advanced adenocarcinoma of the
breast
- Estrogen receptor positive disease
- Human Epidermal Growth Factor Receptor 2 negative disease
- Measurable disease per Response Evaluation Criteria in Solid Tumors v1.1
Exclusion Criteria:
- Prior therapy within the following windows:
- Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine
therapy < 14 days;
- Any investigational drug therapy < 28 days or 5 half-lives (whichever is shorter)
- Any prior systemic chemotherapy regardless of the stop date, but the subject must
have recovered to eligibility levels from prior toxicity
- Prior treatment with CDK4/6 inhibitors
- Unexplained symptomatic endometrial disorders (including, but not limited to,
endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib |
Time Frame: | Through study completion, anticipated to be 21 months |
Safety Issue: | |
Description: | 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
Measure: | Determine tumor responses to combination treatment |
Time Frame: | Through study completion, anticipated to be 21 months |
Safety Issue: | |
Description: | Measured by radiographic responses as defined by revised Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Zeno Alpha Inc. |
Trial Keywords
- Dose escalation
- Phase 1 combination
- Selective estrogen receptor degrader
- Hormone sensitive
- Estrogen receptor
- Hormone receptor
Last Updated
July 20, 2021