A Study of ZN-c5 in Subjects With Breast Cancer

Zeno Alpha Inc.181 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

181

Conditions

Breast Cancer

Interventions

ZN-c5DRUG

ZN-c5 is a study drug

PalbociclibDRUG

Palbociclib (IBRANCE®) is an approved drug

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 follicle-stimulating hormone level within the laboratory's reference range for postmenopausal females; * Documented bilateral oophorectomy; or 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 (stable disease, partial response, or complete response 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)

Locations (38)

Outcomes

Primary Outcomes

Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy

CBR is defined as the number of participants who have at least 1 confirmed response of complete response (CR) or partial response (PR) (only if participant has measurable disease), or stable disease (SD) \>= 24 weeks (or non-CR/non-progressive disease (PD) \>=24 weeks for participants with non-measurable disease) prior to any evidence of progression.

Time frame: 24 weeks

Best Overall Response (BOR) for ZN-c5 as a Monotherapy

Best overall response was summarized categorically based on the four RECIST categories: CR, PR, SD and PD.

Time frame: 24 weeks

Secondary Outcomes

Monotherapy Only: Percentage of Participants With Progression-Free Survival (PFS) at 2 Months

PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 2 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Time frame: 2 months

Monotherapy Only: Percentage of Participants With Progression-Free Survival at 4 Months

PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 4 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Time frame: 4 months

Monotherapy Only: Percentage of Participants With Progression-Free Survival at 6 Months

PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 6 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Data from ClinicalTrials.gov

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Site 3

Tucson, Arizona, United States

Site 5

Los Angeles, California, United States

Site 48

Bethesda, Maryland, United States

Site 47

St Louis, Missouri, United States

Site 7

New York, New York, United States

Site 2

New York, New York, United States

Site 50

Charleston, South Carolina, United States

Site 4

Nashville, Tennessee, United States

Site 1

Houston, Texas, United States

Site 8

Houston, Texas, United States

...and 28 more locations

Time frame: 6 months

Monotherapy Only: Percentage of Participants With Progression-Free Survival at 8 Months

PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 8 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Time frame: 8 months

Monotherapy Only: Percentage of Participants With Progression-Free Survival at 10 Months

PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 10 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Time frame: 10 months

Monotherapy Only: Percentage of Participants With Progression-Free Survival at 12 Months

PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 12 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Time frame: 12 months

Monotherapy Only: Percentage of Participants With Overall Survival (OS) at 2 Months

OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 2 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Time frame: 2 months

Monotherapy Only: Percentage of Participants With Overall Survival at 4 Months

OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 4 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Time frame: 4 months

Monotherapy Only: Percentage of Participants With Overall Survival at 6 Months

OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 6 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Time frame: 6 months

Monotherapy Only: Percentage of Participants With Overall Survival at 8 Months

OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 8 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Time frame: 8 months

Monotherapy Only: Percentage of Participants With Overall Survival at 10 Months

OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 10 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Time frame: 10 months

Monotherapy Only: Percentage of Participants With Overall Survival at 12 Months

OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 12 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.

Time frame: 12 months

Objective Response Rate (ORR) for ZN-c5 as a Monotherapy

ORR is defined as the number of participants with measurable disease who have at least 1 confirmed response of CR or PR prior to any evidence of progression (as defined by RECIST v1.1).

Time frame: 24 weeks