Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ZN-c5 · 3 trials · 1 indication
Measured by the number of treatment-emergent adverse events and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
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 was summarized categorically based on the four RECIST categories: CR, PR, SD and PD.
| Arm | Type | Description |
|---|---|---|
| ZN-c5 + abemaciclib combination therapy | EXPERIMENTAL | Participants will take abemaciclib (150mg) orally twice a day and ZN-c5 (dose escalation) orally once or twice a day to determine the safety, tolerability, and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D). |
| ZN-c5 | EXPERIMENTAL | - |
| 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. |
| Name | Type | Description |
|---|---|---|
| ZN-c5 | DRUG | ZN-c5 is the study drug. |
| Abemaciclib | DRUG | Abemaciclib (VERZENIO®) is an approved drug. |
| Palbociclib | DRUG | Palbociclib (IBRANCE®) is an approved drug |
Inclusion Criteria: * Age ≥ 18 years of age * Women can be peri- or 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 s...
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ZN-c5 is an investigational small molecule being studied for the treatment of breast cancer. It has been evaluated in Phase 1 clinical trials in participants with breast cancer, including a biomarker-selected patient population. It is not described as approved for any use, and development has focused on breast cancer as its indication.
ZN-c5 is being developed by Zentalis Pharmaceuticals, Inc., which trades under the ticker ZNTL. The company has sponsored the Phase 1 clinical program evaluating ZN-c5 in breast cancer, including studies run in the United States and several additional countries across Europe and Australia.
ZN-c5 is in Phase 1 clinical development. All three of its recorded trials are Phase 1 studies in breast cancer, and all three are listed as completed. The program has enrolled approximately 230 participants in total across those studies, and no later-phase trials are recorded.
ZN-c5 has been studied in three Phase 1 trials in breast cancer: NCT03560531, which enrolled 181 participants; NCT04176757, which enrolled 35 participants; and NCT04514159, which enrolled 14 participants and tested ZN-c5 together with abemaciclib. All three trials are completed, and participants were 18 years or older.
Yes, the ZN-c5 clinical program is biomarker selected, meaning trial enrollment was guided by a biomarker rather than an unselected breast cancer population. The Phase 1 studies in breast cancer used this biomarker-selected approach, and the trials enrolled adults 18 years and older, with no healthy volunteers included.