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®).
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
Interventions
Drug | Synonyms | Arms |
---|
ZN-c5 | | ZN-c5 + palbociclib combination therapy |
Palbociclib | IBRANCE® | 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
Name | Type | Description | Interventions |
---|
ZN-c5 monotherapy | Experimental | 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. | |
ZN-c5 + palbociclib combination therapy | Experimental | 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. | |
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