Breast Cancer
Conditions
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
Brief 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®).
Interventions
DRUGZN-c5
ZN-c5 is a study drug
DRUGPalbociclib
Palbociclib (IBRANCE®) is an approved drug
Sponsors
Zeno Alpha Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose escalation cohorts are planned in monotherapy and combination as well as monotherapy dose expansion, and monotherapy and combination Phase 2.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy | 24 weeks | 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. |
| Best Overall Response (BOR) for ZN-c5 as a Monotherapy | 24 weeks | Best overall response was summarized categorically based on the four RECIST categories: CR, PR, SD and PD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monotherapy Only: Percentage of Participants With Overall Survival (OS) at 2 Months | 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. |
| Monotherapy Only: Percentage of Participants With Progression-Free Survival at 6 Months | 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. |
| Monotherapy Only: Percentage of Participants With Progression-Free Survival at 8 Months | 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. |
| Monotherapy Only: Percentage of Participants With Progression-Free Survival at 10 Months | 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. |
| Monotherapy Only: Percentage of Participants With Progression-Free Survival at 12 Months | 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. |
| Monotherapy Only: Percentage of Participants With Progression-Free Survival (PFS) at 2 Months | 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. |
| Monotherapy Only: Percentage of Participants With Overall Survival at 6 Months | 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. |
| Monotherapy Only: Percentage of Participants With Overall Survival at 8 Months | 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. |
| Monotherapy Only: Percentage of Participants With Overall Survival at 10 Months | 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. |
| Monotherapy Only: Percentage of Participants With Overall Survival at 12 Months | 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. |
| Objective Response Rate (ORR) for ZN-c5 as a Monotherapy | 24 weeks | 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). |
| Monotherapy Only: Percentage of Participants With Overall Survival at 4 Months | 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. |
| Monotherapy Only: Percentage of Participants With Progression-Free Survival at 4 Months | 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. |
Countries
Belarus, Bosnia and Herzegovina, Czechia, Hungary, Lithuania, Russia, Serbia, Ukraine, United States
Participant flow
Recruitment details
Study was initiated on 30 November 2018 and completed on 22 December 2022 (last participant last visit). 29 centers in Belarus, Bosnia and Herzegovina, the Czech Republic, Hungary, Lithuania, Russia, Serbia, Ukraine, and the United States enrolled the participants.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm. | 16 |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm. | 3 |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm. | 3 |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm. | 6 |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm. | 15 |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm. | 3 |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm. | 10 |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm. | 75 |
| Phase 1 (Combination Therapy): ZN-c5 25mg QD + Palbociclib Participants who received ZN-c5 25 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm. | 10 |
| Phase 1 (Combination Therapy): ZN-c5 25mg BID + Palbociclib Participants who received ZN-c5 25 mg BID along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm. | 5 |
| Phase 1 (Combination Therapy): ZN-c5 50mg QD + Palbociclib Participants who received ZN-c5 50 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm. | 18 |
| Phase 1 (Combination Therapy): ZN-c5 50mg BID + Palbociclib Participants who received ZN-c5 50 mg BID along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm. | 2 |
| Phase 1 (Combination Therapy): ZN-c5 100mg QD + Palbociclib Participants who received ZN-c5 100 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm. | 12 |
| Phase 1 (Combination Therapy): ZN-c5 150mg QD + Palbociclib Participants who received ZN-c5 150 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm. | 3 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 4 | 1 | 1 | 2 | 6 | 1 | 4 | 8 | 1 | 3 | 2 | 0 | 4 | 1 |
| Overall Study | Early study termination by sponsor | 9 | 0 | 0 | 4 | 8 | 2 | 5 | 64 | 7 | 2 | 16 | 2 | 6 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Study end per-protocol | 1 | 1 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 0 | 0 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Phase 1 (Monotherapy): ZN-c5 75 mg QD | Phase 1 (Monotherapy): ZN-c5 100 mg QD | Phase 1 (Monotherapy): ZN-c5 75 mg BID | Phase 1 (Monotherapy): ZN-c5 50 mg QD | Phase 1 (Monotherapy): ZN-c5 150 mg QD | Phase 1 (Monotherapy): ZN-c5 150 mg BID | Phase 1 (Monotherapy): ZN-c5 300 mg QD | Phase 2 (Monotherapy): ZN-c5 50 mg QD | Phase 1 (Combination Therapy): ZN-c5 25mg QD + Palbociclib | Phase 1 (Combination Therapy): ZN-c5 25mg BID + Palbociclib | Phase 1 (Combination Therapy): ZN-c5 50mg QD + Palbociclib | Phase 1 (Combination Therapy): ZN-c5 50mg BID + Palbociclib | Phase 1 (Combination Therapy): ZN-c5 100mg QD + Palbociclib | Phase 1 (Combination Therapy): ZN-c5 150mg QD + Palbociclib |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 76 Participants | 0 Participants | 0 Participants | 3 Participants | 5 Participants | 5 Participants | 1 Participants | 5 Participants | 36 Participants | 4 Participants | 2 Participants | 10 Participants | 0 Participants | 4 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 105 Participants | 3 Participants | 3 Participants | 3 Participants | 11 Participants | 10 Participants | 2 Participants | 5 Participants | 39 Participants | 6 Participants | 3 Participants | 8 Participants | 2 Participants | 8 Participants | 2 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 165 Participants | 3 Participants | 3 Participants | 5 Participants | 12 Participants | 12 Participants | 3 Participants | 9 Participants | 74 Participants | 8 Participants | 5 Participants | 17 Participants | 1 Participants | 10 Participants | 3 Participants |
| Region of Enrollment Europe | 72 Participants | 0 Participants | 0 Participants | 0 Participants | 8 Participants | 0 Participants | 0 Participants | 2 Participants | 62 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 109 Participants | 3 Participants | 3 Participants | 6 Participants | 8 Participants | 15 Participants | 3 Participants | 8 Participants | 13 Participants | 10 Participants | 5 Participants | 18 Participants | 2 Participants | 12 Participants | 3 Participants |
| Sex: Female, Male Female | 180 Participants | 3 Participants | 3 Participants | 6 Participants | 16 Participants | 15 Participants | 3 Participants | 10 Participants | 75 Participants | 10 Participants | 5 Participants | 18 Participants | 2 Participants | 11 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 16 | 1 / 3 | 1 / 3 | 2 / 6 | 6 / 15 | 1 / 3 | 4 / 10 | 8 / 75 | 2 / 10 | 3 / 5 | 2 / 18 | 0 / 2 | 4 / 12 | 1 / 3 |
| other Total, other adverse events | 15 / 16 | 3 / 3 | 3 / 3 | 6 / 6 | 14 / 15 | 3 / 3 | 10 / 10 | 55 / 75 | 10 / 10 | 5 / 5 | 18 / 18 | 2 / 2 | 12 / 12 | 3 / 3 |
| serious Total, serious adverse events | 0 / 16 | 0 / 3 | 1 / 3 | 1 / 6 | 2 / 15 | 0 / 3 | 2 / 10 | 9 / 75 | 4 / 10 | 1 / 5 | 2 / 18 | 0 / 2 | 2 / 12 | 1 / 3 |
Outcome results
Primary
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
Population: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | CR | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Non-Responders (NR) | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD | 13 Participants |
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD ≥24 weeks | 7 Participants |
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Not Evaluable (NE) | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PD | 3 Participants |
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PR | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | 8 weeks < SD <24 weeks | 6 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PR | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Non-Responders (NR) | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Not Evaluable (NE) | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | CR | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PD | 2 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD | 1 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | 8 weeks < SD <24 weeks | 1 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD ≥24 weeks | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Not Evaluable (NE) | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | 8 weeks < SD <24 weeks | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | CR | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PR | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Non-Responders (NR) | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PD | 2 Participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD | 1 Participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD ≥24 weeks | 1 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PD | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PR | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Non-Responders (NR) | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | 8 weeks < SD <24 weeks | 5 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Not Evaluable (NE) | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | CR | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD ≥24 weeks | 1 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD | 6 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PR | 1 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | CR | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD | 10 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD ≥24 weeks | 3 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | 8 weeks < SD <24 weeks | 7 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PD | 4 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Non-Responders (NR) | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Not Evaluable (NE) | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD | 3 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | CR | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD ≥24 weeks | 1 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | 8 weeks < SD <24 weeks | 2 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PD | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PR | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Not Evaluable (NE) | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Non-Responders (NR) | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PD | 1 Participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | CR | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD | 7 Participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Not Evaluable (NE) | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | 8 weeks < SD <24 weeks | 3 Participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD ≥24 weeks | 4 Participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Non-Responders (NR) | 1 Participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PR | 1 Participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD | 50 Participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | 8 weeks < SD <24 weeks | 15 Participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PR | 3 Participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Not Evaluable (NE) | 0 Participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | CR | 0 Participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | Non-Responders (NR) | 3 Participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | SD ≥24 weeks | 35 Participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Best Overall Response (BOR) for ZN-c5 as a Monotherapy | PD | 19 Participants |
Primary
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
Population: Full Analysis Set consisted of all participants who received \>=1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy | 7 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy | 1 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy | 1 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy | 4 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy | 1 Participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy | 5 Participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy | 38 Participants |
Secondary
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
Population: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 10 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 10 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 10 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Monotherapy Only: Percentage of Participants With Overall Survival at 10 Months | 83.3 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 10 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Monotherapy Only: Percentage of Participants With Overall Survival at 10 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 10 Months | 90.0 percentage of participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 10 Months | 90.0 percentage of participants |
Secondary
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
Population: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 12 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 12 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 12 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Monotherapy Only: Percentage of Participants With Overall Survival at 12 Months | 83.3 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 12 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Monotherapy Only: Percentage of Participants With Overall Survival at 12 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 12 Months | 90.0 percentage of participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 12 Months | 84.2 percentage of participants |
Secondary
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
Population: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 4 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 4 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 4 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Monotherapy Only: Percentage of Participants With Overall Survival at 4 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 4 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Monotherapy Only: Percentage of Participants With Overall Survival at 4 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 4 Months | 90.0 percentage of participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 4 Months | 97.3 percentage of participants |
Secondary
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
Population: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 6 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 6 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 6 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Monotherapy Only: Percentage of Participants With Overall Survival at 6 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 6 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Monotherapy Only: Percentage of Participants With Overall Survival at 6 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 6 Months | 90.0 percentage of participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 6 Months | 97.3 percentage of participants |
Secondary
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
Population: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 8 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 8 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 8 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Monotherapy Only: Percentage of Participants With Overall Survival at 8 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 8 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Monotherapy Only: Percentage of Participants With Overall Survival at 8 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 8 Months | 90.0 percentage of participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival at 8 Months | 94.0 percentage of participants |
Secondary
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
Population: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival (OS) at 2 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival (OS) at 2 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival (OS) at 2 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Monotherapy Only: Percentage of Participants With Overall Survival (OS) at 2 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival (OS) at 2 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Monotherapy Only: Percentage of Participants With Overall Survival (OS) at 2 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival (OS) at 2 Months | 100.0 percentage of participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Overall Survival (OS) at 2 Months | 98.7 percentage of participants |
Secondary
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
Population: The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1. Only participants with data collected at Month 10 are reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 10 Months | 55.2 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 10 Months | 0.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 10 Months | 16.7 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 10 Months | 16.8 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 10 Months | 0.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 10 Months | 12.5 percentage of participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 10 Months | 35.9 percentage of participants |
Secondary
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
Population: The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1. Only participants with data collected at Month 12 are reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 12 Months | 27.6 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 12 Months | 0.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 12 Months | 16.7 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 12 Months | 16.8 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 12 Months | 0.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 12 Months | 12.5 percentage of participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 12 Months | 26.2 percentage of participants |
Secondary
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
Population: The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1. Only participants with data collected at Month 4 are reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 4 Months | 73.7 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 4 Months | 33.3 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 4 Months | 33.3 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 4 Months | 50.3 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 4 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 4 Months | 62.5 percentage of participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 4 Months | 60.8 percentage of participants |
Secondary
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.
Time frame: 6 months
Population: The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1. Only participants with data collected at Month 6 are reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 6 Months | 64.5 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 6 Months | 33.3 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 6 Months | 16.7 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 6 Months | 33.5 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 6 Months | 66.7 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 6 Months | 50.0 percentage of participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 6 Months | 50.3 percentage of participants |
Secondary
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
Population: The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1. Only participants with data collected at Month 8 are reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 8 Months | 64.5 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 8 Months | 0.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 8 Months | 16.7 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 8 Months | 16.8 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 8 Months | 66.7 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 8 Months | 37.5 percentage of participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival at 8 Months | 44.2 percentage of participants |
Secondary
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
Population: The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival (PFS) at 2 Months | 87.1 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival (PFS) at 2 Months | 66.7 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival (PFS) at 2 Months | 33.3 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Monotherapy Only: Percentage of Participants With Progression-Free Survival (PFS) at 2 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival (PFS) at 2 Months | 73.3 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Monotherapy Only: Percentage of Participants With Progression-Free Survival (PFS) at 2 Months | 100.0 percentage of participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival (PFS) at 2 Months | 87.5 percentage of participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Monotherapy Only: Percentage of Participants With Progression-Free Survival (PFS) at 2 Months | 77.8 percentage of participants |
Secondary
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
Population: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 (Monotherapy): ZN-c5 50 mg QD | Objective Response Rate (ORR) for ZN-c5 as a Monotherapy | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg QD | Objective Response Rate (ORR) for ZN-c5 as a Monotherapy | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 100 mg QD | Objective Response Rate (ORR) for ZN-c5 as a Monotherapy | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 75 mg BID | Objective Response Rate (ORR) for ZN-c5 as a Monotherapy | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg QD | Objective Response Rate (ORR) for ZN-c5 as a Monotherapy | 1 Participants |
| Phase 1 (Monotherapy): ZN-c5 150 mg BID | Objective Response Rate (ORR) for ZN-c5 as a Monotherapy | 0 Participants |
| Phase 1 (Monotherapy): ZN-c5 300 mg QD | Objective Response Rate (ORR) for ZN-c5 as a Monotherapy | 1 Participants |
| Phase 2 (Monotherapy): ZN-c5 50 mg QD | Objective Response Rate (ORR) for ZN-c5 as a Monotherapy | 3 Participants |