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

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: ZN-c5; Drug: Abemaciclib

• Registration Number: NCT04514159
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-14
• Study Start: 2020-11-12
• Primary Completion: 2022-10-24
• Study Completion: 2022-10-24
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZN-c5 + abemaciclib combination therapy	ZN-c5	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).
ZN-c5 + abemaciclib combination therapy	Abemaciclib	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (5)

Site 1; 🇺🇸 Charleston, South Carolina, United States

Site 4; 🇵🇱 Kraków, Poland

Site 5; 🇵🇱 Łódź, Poland

Site 6; 🇵🇱 Grudziądz, Poland

Site 2; 🇺🇸 Gilbert, Arizona, United States