Phase 2 N=181 Treatment

A Study of ZN-c5 in Subjects With Breast Cancer

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03560531 ↗

Enrolled (actual)

181

Serious AEs

13.8%

Results posted

Aug 2024

Primary outcome: Primary: Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy — 7; 0; 1; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ZN-c5 (Drug); Palbociclib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Zeno Alpha Inc.
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy	7; 0; 1; 1; 4; 1	—
PRIMARY Best Overall Response (BOR) for ZN-c5 as a Monotherapy	0; 0; 0; 0; 0; 0	—
SECONDARY Monotherapy Only: Percentage of Participants With Progression-Free Survival (PFS) at 2 Months	87.1; 66.7; 33.3; 100.0; 73.3; 100.0	—
SECONDARY Monotherapy Only: Percentage of Participants With Progression-Free Survival at 4 Months	73.7; 33.3; 33.3; 50.3; 100.0; 62.5	—
SECONDARY Monotherapy Only: Percentage of Participants With Progression-Free Survival at 6 Months	64.5; 33.3; 16.7; 33.5; 66.7; 50.0	—
SECONDARY Monotherapy Only: Percentage of Participants With Progression-Free Survival at 8 Months	64.5; 0.0; 16.7; 16.8; 66.7; 37.5	—
SECONDARY Monotherapy Only: Percentage of Participants With Progression-Free Survival at 10 Months	55.2; 0.0; 16.7; 16.8; 0.0; 12.5	—
SECONDARY Monotherapy Only: Percentage of Participants With Progression-Free Survival at 12 Months	27.6; 0.0; 16.7; 16.8; 0.0; 12.5	—
SECONDARY Monotherapy Only: Percentage of Participants With Overall Survival (OS) at 2 Months	100.0; 100.0; 100.0; 100.0; 100.0; 100.0	—
SECONDARY Monotherapy Only: Percentage of Participants With Overall Survival at 4 Months	100.0; 100.0; 100.0; 100.0; 100.0; 100.0	—
SECONDARY Monotherapy Only: Percentage of Participants With Overall Survival at 6 Months	100.0; 100.0; 100.0; 100.0; 100.0; 100.0	—
SECONDARY Monotherapy Only: Percentage of Participants With Overall Survival at 8 Months	100.0; 100.0; 100.0; 100.0; 100.0; 100.0	—
SECONDARY Monotherapy Only: Percentage of Participants With Overall Survival at 10 Months	100.0; 100.0; 100.0; 83.3; 100.0; 100.0	—
SECONDARY Monotherapy Only: Percentage of Participants With Overall Survival at 12 Months	100.0; 100.0; 100.0; 83.3; 100.0; 100.0	—
SECONDARY Objective Response Rate (ORR) for ZN-c5 as a Monotherapy	0; 0; 0; 0; 1; 0	—

Summary

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®).

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 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03560531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.