A Study of ZN-c5 in Participants With Breast Cancer

Phase 1

Completed

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

• Registration Number: NCT04176757
• Lead Sponsor: Zeno Alpha Inc.

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 available

Study Timeline

• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-25
• Study Start: 2020-01-03
• Primary Completion: 2021-04-27
• Study Completion: 2021-05-25
• Status Verified: 2022-04
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZN-c5	ZN-c5	-

Primary Outcome Measures

Name	Time	Method
Corroborate the single agent Recommended Phase 2 Dose	Throughout the study, an average of 15 months

Secondary Outcome Measures

Name	Time	Method
Dose-biomarker relationship	Throughout the study, an average of 15 months	Percentage positive of IHC staining Ki-67 as compare to baseline

Trial Locations

Locations (10)

Site 1; 🇺🇸 Houston, Texas, United States

Site 2; 🇺🇸 New York, New York, United States

Site 5; 🇺🇸 Seattle, Washington, United States

Site 3; 🇺🇸 Tucson, Arizona, United States

Site 9; 🇦🇺 Sydney, New South Wales, Australia

Site 10; 🇦🇺 Cairns, Queensland, Australia

Site 7; 🇧🇦 Banja Luka, Bosnia and Herzegovina

Site 4; 🇺🇸 Nashville, Tennessee, United States

Site 8; 🇦🇺 Richmond, Victoria, Australia

Site 11; 🇦🇺 Liverpool, New South Wales, Australia