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

Sponsor
Zeno Alpha Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04514159
Collaborator
(none)
14
5
1
36.6
2.8
0.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants will receive the same treatment but ZN-c5 will be given at different doses in this dose escalation study.All participants will receive the same treatment but ZN-c5 will be given at different doses in this dose escalation study.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 12, 2020
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

Drug: ZN-c5
ZN-c5 is the study drug.

Drug: Abemaciclib
Abemaciclib (VERZENIO®) is an approved drug.
Other Names:
  • VERZENIO®
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib [Through study completion, anticipated to be 21 months]

      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

    1. Determine tumor responses to combination treatment [Through study completion, anticipated to be 21 months]

      Measured by radiographic responses as defined by revised Response Evaluation Criteria in Solid Tumor (RECIST) v1.1.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 2 Gilbert Arizona United States 85234
    2 Site 1 Charleston South Carolina United States 29414
    3 Site 6 Grudziądz Poland 86-300
    4 Site 4 Kraków Poland 30-348
    5 Site 5 Łódź Poland 93-513

    Sponsors and Collaborators

    • Zeno Alpha Inc.

    Investigators

    • Study Director: Andrew Henry, Zeno Alpha Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zeno Alpha Inc.
    ClinicalTrials.gov Identifier:
    NCT04514159
    Other Study ID Numbers:
    • ZN-c5-003
    First Posted:
    Aug 14, 2020
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zeno Alpha Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 15, 2022