A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer

NCT ID: NCT04514159

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-12
• Study Completion Date: 2022-10-24

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

ZN-c5

Intervention Type: DRUG

ZN-c5 is the study drug.

Abemaciclib

Intervention Type: DRUG

Abemaciclib (VERZENIO®) is an approved drug.

Interventions

ZN-c5

ZN-c5 is the study drug.

Intervention Type: DRUG

Abemaciclib

Abemaciclib (VERZENIO®) is an approved drug.

Intervention Type: DRUG

Other Intervention Names

VERZENIO®

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zeno Alpha Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carrie Brownstein, MD

Role: STUDY_CHAIR

Zeno Alpha Inc.

Locations

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

Countries

United States; Poland

Other Identifiers

ZN-c5-003

Identifier Type: -

Identifier Source: org_study_id