Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ZN-c5 · 4 trials · 2 indications
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
Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time
Maximum concentration
Time to maximum concentration
Area under the plasma concentration-time curve (AUC) from time zero to infinity
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). |
| Treatment Sequence A-B | EXPERIMENTAL | Participants will take ZN-c5 (150mg), single dose, under fasted conditions, and a week later, will take the same drug under fed conditions to determine the comparative bioavailability of ZN-c5 under these conditions. |
| Treatment Sequence B-A | EXPERIMENTAL | Participants will take ZN-c5 (150mg), single dose, under fed conditions, and a week later, will take the same drug under fasted conditions to determine the comparative bioavailability of ZN-c5 under these conditions. |
| 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 is also being evaluated in healthy post-menopausal subjects in a food effect study. ZN-c5 is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
ZN-c5 is being developed by Zentalis Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ZNTL. The company is conducting Phase 1 clinical trials of ZN-c5 in breast cancer and healthy subjects.
ZN-c5 is in Phase 1 clinical development. All four clinical trials listed for ZN-c5 are Phase 1 studies, and all have been completed. ZN-c5 is an investigational drug and has not received FDA approval.
ZN-c5 has been studied in four completed Phase 1 clinical trials. These include NCT03560531 and NCT04176757 in breast cancer, NCT04514159 combining ZN-c5 with abemaciclib in breast cancer, and NCT04561752, a food effect study in healthy post-menopausal women.
ZN-c5 is a distinct investigational small molecule developed by Zentalis Pharmaceuticals. It is not known to be the same as any other approved drug. It is being studied as a monotherapy and in combination with abemaciclib for breast cancer.