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

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ClinicalTrials.gov Identifier: NCT04514159
Recruitment Status : Recruiting
First Posted : August 14, 2020
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Zeno Alpha Inc.

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
Breast Cancer Drug: ZN-c5 Drug: Abemaciclib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : November 12, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Abemaciclib

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 Name: VERZENIO®




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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514159


Contacts
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Contact: Mieke Ptaszynski, MD 858-263-4333 info@zentalis.com

Locations
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United States, Arizona
Site 2 Recruiting
Gilbert, Arizona, United States, 85234
United States, New Jersey
Site 3 Recruiting
Florham Park, New Jersey, United States, 07932
United States, South Carolina
Site 1 Recruiting
Charleston, South Carolina, United States, 29414
Poland
Site 4 Recruiting
Kraków, Poland, 30-348
Site 5 Not yet recruiting
Łódź, Poland, 93-513
Sponsors and Collaborators
Zeno Alpha Inc.
Investigators
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Study Director: Mieke Ptaszynski, MD Zeno Alpha Inc.
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Responsible Party: Zeno Alpha Inc.
ClinicalTrials.gov Identifier: NCT04514159    
Other Study ID Numbers: ZN-c5-003
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zeno Alpha Inc.:
Dose escalation
Phase 1 combination
Selective estrogen receptor degrader
Hormone sensitive
Estrogen receptor
Hormone receptor
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases