A Study of ZN-c5 in Participants With Breast Cancer

A Phase 1 Open-Label, Multicenter Study to Evaluate Biomarkers for ZN-c5 in Subjects With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer

This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: ZN-c5

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Site 11
    • Sydney, New South Wales, Australia, 2109
      • Site 9
  • Queensland
    • Cairns, Queensland, Australia, 4870
      • Site 10
  • Victoria
    • Richmond, Victoria, Australia, 3121
      • Site 8
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • Site 7
• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Site 3
  • New York
    • New York, New York, United States, 10032
      • Site 2
  • Tennessee
    • Nashville, Tennessee, United States, 37240
      • Site 4
  • Texas
    • Houston, Texas, United States, 77030
      • Site 1
  • Washington
    • Seattle, Washington, United States, 98109
      • Site 5

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed and dated ICF
2. Age ≥ 18 years of age, either gender

3. Females must be postmenopausal as defined by at least one of the following:

   1. Age ≥ 60 years;
   2. 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 levels within the local laboratory's normal reference range for postmenopausal females;
   3. Documented bilateral oophorectomy
4. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

6. Adequate organ function defined as follows:

   1. Hematologic: Platelets ≥ 100 × 109/L; Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count ≥ 1.5 × 109/L (without platelet transfusion or any hematopoietic growth factors within previous 7 days of the hematologic laboratory values obtained at the Screening Visit)

   2. Hepatic: Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT)

      ≤ 2.5 × upper limit of normal (ULN); Total or conjugated bilirubin ≤ 1.5 × ULN

   3. Renal: Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min

Exclusion Criteria:

1. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of the first administration of study drug
2. Treatment with another investigational drug or other intervention within 28 days before the first administration of study drug
3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication, including any unresolved nausea, vomiting, or diarrhea that is CTCAE v.5.0 Grade > 1
4. Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of study Day 1
5. Uncontrolled inter-current illness
6. History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ZN-c5	Drug: ZN-c5; ZN-c5 study drug to be administered orally daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Corroborate the single agent Recommended Phase 2 Dose	Throughout the study, an average of 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-biomarker relationship	Percentage positive of Immunohistochemistry (IHC) staining Estrogen Receptor (ER) as compare to baseline	Throughout the study, an average of 15 months
Dose-biomarker relationship	Percentage positive of IHC staining Progesterone Receptor (PR) as compare to baseline	Throughout the study, an average of 15 months
Dose-biomarker relationship	Percentage positive of IHC staining Ki-67 as compare to baseline	Throughout the study, an average of 15 months

Collaborators and Investigators

• Sponsor: Zeno Alpha Inc.
• Investigators: Study Director: Mieke Ptaszynski, MD, Zeno Alpha Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2020
• Primary Completion (ACTUAL): April 27, 2021
• Study Completion (ACTUAL): May 25, 2021

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (ACTUAL): November 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ZN-c5-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No