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History of Changes for Study: NCT04514159
A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer
Latest version (submitted August 11, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 11, 2020 None (earliest Version on record)
2 August 14, 2020 Contacts/Locations and Study Status
3 October 29, 2020 Recruitment Status, Study Status and Contacts/Locations
4 November 4, 2020 Study Status
5 January 19, 2021 Study Status and Contacts/Locations
6 March 29, 2021 Study Status and Contacts/Locations
7 July 19, 2021 Study Status and Contacts/Locations
8 September 13, 2021 Study Status and Contacts/Locations
9 November 16, 2021 Contacts/Locations and Study Status
10 February 14, 2022 Study Status and Contacts/Locations
11 May 2, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
12 June 3, 2022 Study Status
13 August 11, 2022 Contacts/Locations and Study Status
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Study NCT04514159
Submitted Date:  August 11, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: ZN-c5-003
Brief Title: A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer
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
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2020
Overall Status: Not yet recruiting
Study Start: September 2020
Primary Completion: June 2022 [Anticipated]
Study Completion: December 2022 [Anticipated]
First Submitted: August 11, 2020
First Submitted that
Met QC Criteria:
August 11, 2020
First Posted: August 14, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
August 11, 2020
Last Update Posted: August 14, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Zeno Alpha Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Breast Cancer
Keywords: Dose escalation
Phase 1 combination
Selective estrogen receptor degrader
Hormone sensitive
Estrogen receptor
Hormone receptor
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
All participants will receive the same treatment but ZN-c5 will be given at different doses in this dose escalation study.
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 18 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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®
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib
[ Time Frame: 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
[ Time Frame: 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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)
Open or close this module Contacts/Locations
Central Contact Person: Zeno Alpha
Telephone: 858-263-4333
Email: info@zentalis.com
Study Officials: Dimitris Voliotis, MD
Study Chair
Zeno Alpha Inc.
Locations: United States, Arizona
Site 2
Gilbert, Arizona, United States, 85234
United States, New Jersey
Site 3
Florham Park, New Jersey, United States, 07932
United States, South Carolina
Site 1
Charleston, South Carolina, United States, 29414
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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