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

Sponsor
Zeno Alpha Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04514159
Collaborator
(none)
18
Enrollment
5
Locations
1
Arm
36.6
Anticipated Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 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

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1Site 2GilbertArizonaUnited States85234
    2Site 1CharlestonSouth CarolinaUnited States29414
    3Site 6GrudziądzPoland86-300
    4Site 4KrakówPoland30-348
    5Site 5ŁódźPoland93-513

    Sponsors and Collaborators

    • Zeno Alpha Inc.

    Investigators

    • Study Chair: Dimitris Voliotis, MD, 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:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    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 Nov 18, 2021