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

Breast Cancer Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT04514159
• Other study ID #: ZN-c5-003
• Status: Completed
• Phase: Phase 1
• Start date: November 12, 2020
• Est. completion date: October 24, 2022

Study information

• Verified date: January 2023
• Source: Zeno Alpha Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 24, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• ZN-c5
ZN-c5 is the study drug.
• Abemaciclib
Abemaciclib (VERZENIO®) is an approved drug.

Locations

Country	Name	City	State
Poland	Site 6	Grudziadz
Poland	Site 4	Kraków
Poland	Site 5	Lódz
United States	Site 1	Charleston	South Carolina
United States	Site 2	Gilbert	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Zeno Alpha Inc.

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib	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	Through study completion, anticipated to be 21 months
Secondary	Determine tumor responses to combination treatment	Measured by radiographic responses as defined by revised Response Evaluation Criteria in Solid Tumor (RECIST) v1.1.	Through study completion, anticipated to be 21 months