A Study of ZN-c5 in Participants With Breast Cancer

• ClinicalTrials.gov Identifier: NCT04176757
• Recruitment Status: Completed
• First Posted: November 25, 2019
• Last Update Posted: August 1, 2022
• Sponsor: Zeno Alpha Inc.
• Information provided by (Responsible Party): Zeno Alpha Inc.

Tracking Information

• First Submitted Date: November 15, 2019
• First Posted Date: November 25, 2019
• Last Update Posted Date: August 1, 2022
• Actual Study Start Date: January 3, 2020
• Actual Primary Completion Date: April 27, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 21, 2019): Corroborate the single agent Recommended Phase 2 Dose [ Time Frame: Throughout the study, an average of 15 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 25, 2019)

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

Original Secondary Outcome Measures (submitted: November 21, 2019)

Dose-biomarker relationship [ Time Frame: Throughout the study, an average of 15 months ]

• Percentage positive of Immunohistochemistry (IHC) staining Estrogen Receptor (ER) as compare to baseline
• Percentage positive of IHC staining Progesterone Receptor (PR) as compare to baseline
• Percentage positive of IHC staining Ki-67 as compare to baseline

• 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 in Participants With Breast Cancer
• Official Title: 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
• Brief Summary: This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Breast Cancer

Intervention

Drug: ZN-c5

ZN-c5 study drug to be administered orally daily

Study Arms

Experimental: ZN-c5

Intervention: Drug: ZN-c5

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 28, 2022): 35
• Original Estimated Enrollment (submitted: November 21, 2019): 36
• Actual Study Completion Date: May 25, 2021
• Actual Primary Completion Date: April 27, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

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: Australia, Bosnia and Herzegovina, United States
• Removed Location Countries: Bulgaria, Hong Kong, Serbia

Administrative Information

• NCT Number: NCT04176757
• Other Study ID Numbers: ZN-c5-002
• 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

• Plan to Share IPD: No

• 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 Director: Mieke Ptaszynski, MD; Zeno Alpha Inc.

• PRS Account: Zeno Alpha Inc.
• Verification Date: April 2022