Clinical trial NCT04514159: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Dose escalation
Phase 1 combination
Selective estrogen receptor degrader
Hormone sensitive
Estrogen receptor
Hormone receptor
Lead sponsor: Zeno Alpha Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the same treatment but ZN-c5 will be given at different doses in this dose escalation study.
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib
timeFrame: Through study completion, anticipated to be 21 months
Secondary outcomes:
measure: Determine tumor responses to combination treatment
timeFrame: Through study completion, anticipated to be 21 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Site 2
state: Arizona
city: Charleston
country: United States
facility: Site 1
state: South Carolina
city: Grudziądz
country: Poland
facility: Site 6
city: Kraków
country: Poland
facility: Site 4
city: Łódź
country: Poland
facility: Site 5
Study officials:
affiliation: Zeno Alpha Inc.
name: Carrie Brownstein, MD
role: STUDY_CHAIR
References: