A Phase 1b Study of ZN-c3 in Combination With Chemotherapy in Patients With Platinum-Resistant Ovarian, Peritoneal or Fallopian Tube Cancer

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


Study Design

Open-Label, Non-randomized


ORR, DCR, DoR, PFS, evaluated per RECIST


Exploratory: CCNE1 AMP


Aze+CarboPt: 36 evaluable: ORR: 35.7%; DoR: 11.4 months; DCR (4 months): 57.1%; PFS: 10.4 months
Aze+Pac: 22 evaluable: ORR: 50%; DoR: 5.6 months; DCR (4 months): 81.8%; PFS: 7.4 months
Aze+Gem: 13 evaluable: ORR: 38.5%; DoR: 6.2 months; DCR (4 months): 46.2%; PFS: 8.3 months
Aze+PLD: 31 evaluable: ORR: 19.4%; DoR: 7.3 months; DCR (4 months): 77.4%; PFS: 6.3 months

Clinically Significant Adverse Events

Aze+chemotherapy vs Aze:
Serious AE:
Grade 3-4 AE: neutropenia (54.7 vs 25.5%)


Azenosertib (ZN-c3), combined with chemotherapy, is well-tolerated and demonstrates clinical activity in patients with Pt-R or Pt-Rf OC


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

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