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

NCT04514159 | Completed Phase 1 FDA Drug

• 1 other identifier: ZN-c5-003
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 5

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

Keywords

Dose escalation; Phase 1 combination; Selective estrogen receptor degrader; Hormone sensitive; Estrogen receptor; Hormone receptor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determine tumor responses to combination treatment

  Through study completion, anticipated to be 21 months

Study Arms (1)

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).

Drug: ZN-c5; Drug: Abemaciclib

Interventions

ZN-c5 DRUG

ZN-c5 is the study drug.

ZN-c5 + abemaciclib combination therapy

Abemaciclib DRUG

Abemaciclib (VERZENIO®) is an approved drug.

Also known as: VERZENIO®

ZN-c5 + abemaciclib combination therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zeno Alpha Inc.: lead

Study Sites (5)

Site 2

Gilbert, Arizona, 85234, United States

Location

Site 1

Charleston, South Carolina, 29414, United States

Location

Site 6

Grudziądz, 86-300, Poland

Location

Site 4

Krakow, 30-348, Poland

Location

Site 5

Lodz, 93-513, Poland

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

abemaciclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Carrie Brownstein, MD

  Zeno Alpha Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will receive the same treatment but ZN-c5 will be given at different doses in this dose escalation study.

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: November 12, 2020
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

PL (3); US (2)