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.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: ZN-c5	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 3, 2020
• Actual Primary Completion Date: April 27, 2021
• Actual Study Completion Date: May 25, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: ZN-c5	Drug: ZN-c5; ZN-c5 study drug to be administered orally daily

Outcome Measures

Primary Outcome Measures :

1. Corroborate the single agent Recommended Phase 2 Dose [ Time Frame: Throughout the study, an average of 15 months ]

Secondary Outcome Measures :

1. 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
2. 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
3. Dose-biomarker relationship [ Time Frame: Throughout the study, an average of 15 months ]
   Percentage positive of IHC staining Ki-67 as compare to baseline

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Arizona

Site 3

Tucson, Arizona, United States, 85719

United States, New York

Site 2

New York, New York, United States, 10032

United States, Tennessee

Site 4

Nashville, Tennessee, United States, 37240

United States, Texas

Site 1

Houston, Texas, United States, 77030

United States, Washington

Site 5

Seattle, Washington, United States, 98109

Australia, New South Wales

Site 11

Liverpool, New South Wales, Australia, 2170

Site 9

Sydney, New South Wales, Australia, 2109

Australia, Queensland

Site 10

Cairns, Queensland, Australia, 4870

Australia, Victoria

Site 8

Richmond, Victoria, Australia, 3121

Bosnia and Herzegovina

Site 7

Banja Luka, Bosnia and Herzegovina, 78000

Sponsors and Collaborators

Zeno Alpha Inc.

Investigators

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

More Information

• Responsible Party: Zeno Alpha Inc.
• ClinicalTrials.gov Identifier: NCT04176757
• Other Study ID Numbers: ZN-c5-002
• First Posted: November 25, 2019
• Last Update Posted: August 1, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases