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

• ClinicalTrials.gov Identifier: NCT04514159
• Recruitment Status: Completed
• First Posted: August 14, 2020
• Last Update Posted: February 1, 2023
• Sponsor: Zeno Alpha Inc.
• Information provided by (Responsible Party): Zeno Alpha Inc.

Tracking Information

• First Submitted Date: August 11, 2020
• First Posted Date: August 14, 2020
• Last Update Posted Date: February 1, 2023
• Actual Study Start Date: November 12, 2020
• Actual Primary Completion Date: October 24, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 11, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 11, 2020)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

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

• Condition: Breast Cancer

Intervention

• Drug: ZN-c5
  ZN-c5 is the study drug.
• Drug: Abemaciclib
  Abemaciclib (VERZENIO®) is an approved drug.
  Other Name: VERZENIO®

Study Arms

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).

Interventions:

• Drug: ZN-c5
• Drug: Abemaciclib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 2, 2022): 14
• Original Estimated Enrollment (submitted: August 11, 2020): 18
• Actual Study Completion Date: October 24, 2022
• Actual Primary Completion Date: October 24, 2022 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Poland, United States
• Removed Location Countries: Bosnia and Herzegovina

Administrative Information

• NCT Number: NCT04514159
• Other Study ID Numbers: ZN-c5-003
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Zeno Alpha Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Zeno Alpha Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Carrie Brownstein, MD; Zeno Alpha Inc.

• PRS Account: Zeno Alpha Inc.
• Verification Date: January 2023