Clinical Trials /

A Study of ZN-c5 in Subjects With Breast Cancer

NCT03560531

Description:

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®).

Related Conditions:
  • Breast Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of ZN-c5 in Subjects With Breast Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: ZN-c5-001
  • NCT ID: NCT03560531

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
ZN-c5ZN-c5 + palbociclib combination therapy
PalbociclibIBRANCE®ZN-c5 + palbociclib combination therapy

Purpose

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®).

Trial Arms

NameTypeDescriptionInterventions
ZN-c5 monotherapyExperimentalDose 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.
  • ZN-c5
ZN-c5 + palbociclib combination therapyExperimentalDose 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.
  • ZN-c5
  • Palbociclib

Eligibility Criteria

        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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Measured by the number of treatment-emergent adverse events

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description:Measured by the number of treatment-emergent adverse events
Measure: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)
Safety Issue:
Description:Measured by the number of treatment-emergent adverse events

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Zeno Alpha Inc.

Trial Keywords

  • Estrogen receptor
  • Hormone receptor
  • Selective estrogen receptor degrader
  • Hormone sensitive
  • Phase 1 Dose Escalation
  • Phase 2 Combination
  • Phase 1 Dose Expansion
  • Phase 2 Monotherapy

Last Updated

July 20, 2021