A Study of ZN-c5 in Subjects With Breast Cancer

April 27, 2023 updated by: Zeno Alpha Inc.

A Phase 1/2 Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of ZN-c5 Alone and in Combination With Palbociclib in Subjects With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer

This is a Phase 1/2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer. ZN-c5 will be evaluated both as monotherapy and in combination with palbociclib (IBRANCE®).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 223040
        • Site 46
      • Vitebsk, Belarus, 210603
        • Site 45
  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina, 78000
        • Site 10
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Site 9
      • Tuzla, Bosnia and Herzegovina, 75000
        • Site 11
  • Czechia
      • Brno, Czechia, 65653
        • Site 29
      • Olomouc, Czechia, 77900
        • Site 28
      • Praha 5, Czechia, 15006
        • Site 30
  • Hungary
      • Budapest, Hungary, H-1062
        • Site 51
      • Kecskemét, Hungary, H-6000
        • Site 35
      • Pécs, Hungary, H-7624
        • Site 37
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Site 17
      • Vilnius, Lithuania, 08660
        • Site 16
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620036
        • Site 42
      • Nizhniy Novgorod, Russian Federation, 603089
        • Site 40
      • Omsk, Russian Federation, 644013
        • Site 52
      • Pyatigorsk, Russian Federation, 357502
        • Site 41
      • Saint Petersburg, Russian Federation, 197022
        • Site 39
  • Serbia
      • Belgrade, Serbia, 11000
        • Site 18
      • Belgrade, Serbia, 11080
        • Site 19
      • Niš, Serbia, 18000
        • Site 21
      • Novi Sad, Serbia, 21204
        • Site 20
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Site 25
      • Kharkiv, Ukraine, 61070
        • Site 27
      • Kropyvnytskyi, Ukraine, 25006
        • Site 24
      • Kryvyi Rih, Ukraine, 50048
        • Site 26
      • Kyiv, Ukraine, 03115
        • Site 23
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Site 3
    • California
      • Los Angeles, California, United States, 91010
        • Site 5
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Site 48
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Site 47
    • New York
      • New York, New York, United States, 10029
        • Site 7
      • New York, New York, United States, 10032
        • Site 2
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Site 50
    • Tennessee
      • Nashville, Tennessee, United States, 37240
        • Site 4
    • Texas
      • Houston, Texas, United States, 77030
        • Site 1
      • Houston, Texas, United States, 77030
        • Site 8
    • Washington
      • Seattle, Washington, United States, 98195
        • Site 6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years of age

    • Women can be 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 FSH level within the laboratory's reference range for postmenopausal females;
    • Documented bilateral oophorectomy;
    • Can be peri- or premenopausal, however, they 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 (metastatic or locoregionally recurrent) adenocarcinoma of the breast, not amenable to any potential curative intervention
  • Estrogen Receptor (ER) positive disease
  • Human Epidermal Growth Factor Receptor 2 (HER2) negative disease
  • Documented prior response to endocrine therapy for metastatic disease (SD, PR, or CR by RECIST v1.1 criteria) lasting > 6 months
  • Evaluable or measurable disease by RECIST v1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if progression at the treated site after completion of therapy is clearly documented.

Exclusion Criteria:

  • Prior anticancer or investigational drugs for the treatment of ER+/HER2 negative advanced breast cancer within the following windows:

    • Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy < 14 days before first dose of study treatment
    • Any chemotherapy < 28 days before first dose of study, except for Phase 2 monotherapy which requires no prior chemotherapy treatment.
    • Any investigational drug therapy < 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment
  • Unexplained symptomatic endometrial disorders (including, but not limited to endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ZN-c5 monotherapy
Dose escalation cohorts are planned to determine maximum tolerated dose(MTD) or recommended phase 2 dose (RP2D) of ZN-c5 as well as expansion cohorts and a Phase 2 cohort.
Drug: ZN-c5
ZN-c5 is a study drug
Experimental: ZN-c5 + palbociclib combination therapy
Dose escalation cohorts are planned to determine maximum tolerated dose(MTD) or recommended phase 2 dose (RP2D) of ZN-c5 in combination with palbociclib as well as a Phase 2 cohort.
Drug: ZN-c5
ZN-c5 is a study drug
Drug: Palbociclib
Palbociclib (IBRANCE®) is an approved drug
Other Names:
  • IBRANCE®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 ESC: Determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) for ZN-c5 as a monotherapy
Time Frame: 9 months
9 months
Phase 1 ESC: Determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) for ZN-c5 when administered in combination with palbociclib
Time Frame: 9 months
9 months
Phase 1 EXP: Safety and tolerability of ZN-c5 as a monotherapy as measured by number of treatment-emergent adverse events
Time Frame: 9 months
Measured by the number of treatment-emergent adverse events
9 months
Phase 2: Determine preliminary anti-tumor efficacy (Clinical Benefit Rate [CBR]) for ZN-c5 as a monotherapy
Time Frame: Through study completion (approximately 2 years)
Through study completion (approximately 2 years)
Phase 2: Determine preliminary anti-tumor efficacy (CBR) for ZN-c5 when administered in combination with palbociclib
Time Frame: Through study completion (approximately 2 years)
Through study completion (approximately 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of ZN-c5 as a monotherapy as measured by number of treatment-emergent adverse events
Time Frame: Through study completion (approximately 2 years)
Measured by the number of treatment-emergent adverse events
Through study completion (approximately 2 years)
Safety and tolerability of ZN-c5 in combination with palbociclib as measured by number of treatment emergent adverse events
Time Frame: Through study completion (approximately 2 years)
Measured by the number of treatment-emergent adverse events
Through study completion (approximately 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeno Alpha Inc.

Investigators

  • Study Director: Zeno Alpha, Inc., Zeno Alpha Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2018

Primary Completion (Actual)

April 26, 2022

Study Completion (Actual)

December 22, 2022

Study Registration Dates

First Submitted

June 5, 2018

First Submitted That Met QC Criteria

June 15, 2018

First Posted (Actual)

June 18, 2018

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZN-c5-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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