| Trial ID # | NCT04516447 |
| Phase | I |
| Drug Class | Cell Cycle Inhibitors: Wee1 |
| Drug Name | Azenosertib |
| Alternate Drug Names | ZN-c3 |
| Drugs in Trial | Azenosertib, Carboplatin, Liposomal doxorubicin, Paclitaxel, Gemcitabine |
| Eligible Participant | Platinum resistant or refractory ovarian cancer |
| Patients Enrolled | 115; median 2 prior therapies (1-4); 79.1% Pt-R, 20.9% Pt-Rf |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, DoR, PFS, evaluated per RECIST |
| Biomarkers | Exploratory: CCNE1 AMP |
| Efficacy | Aze+CarboPt: 36 evaluable: ORR: 35.7%; DoR: 11.4 months; DCR (4 months): 57.1%; PFS: 10.4 months |
| Clinically Significant Adverse Events | Aze+chemotherapy vs Aze: |
| Conclusion | Azenosertib (ZN-c3), combined with chemotherapy, is well-tolerated and demonstrates clinical activity in patients with Pt-R or Pt-Rf OC |
| Reference | Pasic et al. A phase 1b dose-escalation study of ZN-c3, a WEE1 inhibitor, in combination with chemotherapy (CT) in subjects with platinum-resistant or refractory ovarian, peritoneal, or fallopian tube cancer. Cancer Res (2022) 82 (12_Supplement): CT148 Pasic A et al. Poster Liu JF et al. Correlation of cyclin E1 expression and clinical outcomes in a phase 1b dose-escalation study of azenosertib (ZN-c3), a WEE1 inhibitor, in combination with chemotherapy (CT) in patients (pts) with platinum-resistant or refractory (R/R) epithelial ovarian, peritoneal, or fallopian tube cancer (EOC). J Clin Oncol 41, 2023 (suppl 16; abstr 5513) Liu JF et al. Poster |