Clinical Trials /

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

NCT04514159

Description:

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.

Related Conditions:
  • Breast Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: ZN-c5-003
  • NCT ID: NCT04514159

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
ZN-c5ZN-c5 + abemaciclib combination therapy
AbemaciclibVERZENIO®ZN-c5 + abemaciclib combination therapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
ZN-c5 + abemaciclib combination therapyExperimentalParticipants 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).
  • ZN-c5
  • Abemaciclib

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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib
Time Frame:Through study completion, anticipated to be 21 months
Safety Issue:
Description: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

Measure:Determine tumor responses to combination treatment
Time Frame:Through study completion, anticipated to be 21 months
Safety Issue:
Description:Measured by radiographic responses as defined by revised Response Evaluation Criteria in Solid Tumor (RECIST) v1.1.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Zeno Alpha Inc.

Trial Keywords

  • Dose escalation
  • Phase 1 combination
  • Selective estrogen receptor degrader
  • Hormone sensitive
  • Estrogen receptor
  • Hormone receptor

Last Updated

August 11, 2020