Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06369155 | Azenosertib in Uterine Serous Carcinoma: Biomarker Study | PHASE2 | RECRUITING | 25 | — | — | Mar 5, 2025 | Jan 31, 2028 | Mar 2, 2026 | 2 | United States |
| NCT04814108 | A Study of Azenosertib (ZN-c3) in Women With Recurrent or Persistent Uterine Serous Carcinoma | PHASE2 | COMPLETED | 92 | — | — | Jul 28, 2021 | Oct 22, 2025 | Mar 18, 2026 | 56 | United States, Australia +2 |
Replication fork speed assessed by DNA fiber assays in PDO models. Responder defined as participants achieving complete response (CR) or partial response (PR) based on RECISTv1.1 criteria. Wilcoxon rank sum tests will be used to compare the percentage change in replication fork speed with exposure to WEE1 inhibition in co-clinical models between overall response responder and non-responder.
Replication fork speed assessed by DNA fiber assays in PDO models. PFS6 is a binary endpoint where patients that are alive and progression free (per RECIST 1.1) at 6 months are considered responders. All other patients (those that died or progressed prior to 6 months or those with less than 6 months of follow-up for progression) are considered non-responders. Wilcoxon rank sum tests will be used to compare the percentage change in replication fork speed with exposure to WEE1 inhibition in co-clinical models between overall response responder and non-responder.
To determine the safety and tolerability of ZN-c3 in subjects with recurrent or persistent USC.
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC
| Arm | Type | Description |
|---|---|---|
| Azenosertib | EXPERIMENTAL | 25 participants will be enrolled and will complete study procedures as follows: * Baseline visit with assessments and CT or MRI scan. * CT or MRIs scans every 2 cycles. * Cycle 1 through End of Treatment: --Days 1 through 5, 8 through 12, and 15 through 19: Predetermined dose of Azenosertib 1x daily. * End of Treatment visit. |
| Azenosertib Single Agent | EXPERIMENTAL | Azenosertib (ZN-c3) taken orally with food |
| Name | Type | Description |
|---|---|---|
| Azenosertib | DRUG | Wee1 inhibitor, 25mg and 100mg tablets, taken orally per protocol. |
Inclusion Criteria: * Participants must have histologically or cytologically confirmed recurrent or persistent uterine serous carcinoma. For the purposes of this study, uterine carcinomas (with the exception of carcinosarcomas) that have any component that is considered serous will be considered a ...