A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression
Start Date
4/17/2026
Completion Date
4/30/2030
Summary
This is a randomized, Phase 3 trial designed to evaluate the efficacy and safety of azenosertib compared to Investigator's choice of chemotherapy in subjects with platinum-resistant ovarian cancer whose tumors are positive for cyclin E1 protein expression.
Detailed Description
A Phase 3 study to evaluate the efficacy, safety, and overall clinical benefit of azenosertib (ZN-c3) compared with Investigator's choice of chemotherapy in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Azenosertib is a selective and orally bioavailable inhibitor of WEE1. In HGSOC, high Cyclin E1 protein drives replication stress and increases tumor reliance on WEE1-mediated G2/M checkpoint control. Treating tumor cells with azenosertib promotes premature cell cycle progression leading to increased replication stress and accumulation of DNA damage pushing cells to mitotic catastrophe resulting in tumor cell death.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Investigator's choice of Chemotherapy
Azenosertib
Conditions
Locations
Site 0107
Phoenix, Arizona 85016
United States
Site 0110
Antioch, California 94531
United States
Site 0115
San Francisco, California 94109
United States
Site 0101
Torrance, California 90505
United States
Site 0111
Camden, New Jersey 08103
United States
Site 0108
Columbus, Ohio 43026
United States
Site 0105
Portland, Oregon 97210
United States
Site 0109
Philadelphia, Pennsylvania 19104
United States
Site 0113
Philadelphia, Pennsylvania 19111
United States
Site 0114
Willow Grove, Pennsylvania 19090
United States
Site 0112
Sioux Falls, South Dakota 57105
United States
Site 1101
Randwick, New South Wales 2031
Australia
Site 1102
Adelaide, South Australia 5000
Australia
Site 1103
Nedlands, 6009
Australia
Site 3002
Brussels, 1020
Belgium
Site 3001
Leuven, 3000
Belgium
Site 0201
Toronto, Ontario M5G 2M9
Canada
Site 0204
Montreal, Quebec H1T 2M4
Canada
Site 0203
Montreal, Quebec H2X 0C1
Canada
Site 0202
Sherbrooke, Quebec J1H 5N4
Canada
Site 3508
Besançon, 25000
France
Site 3502
Brest, 29609
France
Site 3507
Dijon, 21079
France
Site 3504
Lyon, 69373
France
Site 3503
Paris, 75014
France
Site 3501
Pierre-Bénite, 69495
France
Site 3509
Saint-Herblain, 44805
France
Site 3505
Strasbourg, 67098
France
Site 3506
Villejuif, 94805
France
Site 3602
Berlin, D-13353
Germany
Site 3601
Dresden, 01307
Germany
Site 3703
Cork, T12 DC4A
Ireland
Site 3702
Dublin, D08 NYH1
Ireland
Site 3801
Bologna, 40138
Italy
Site 3805
Milan, 20132
Italy
Site 3804
Milan, 20141
Italy
Site 3803
Milan, 20159
Italy
Site 3802
Naples, 80131
Italy
Site 3807
Prato, 59100
Italy
Site 3806
Rome, 00168
Italy
Site 4006
Krakow, 30-348
Poland
Site 4001
Lodz, 93-338
Poland
Site 4004
Poznan, 61-848
Poland
Site 4003
Szczecin, 70-111
Poland
Site 1203
Daegu, 42601
South Korea
Site 1206
Goyang-si, 10408
South Korea
Site 1202
Seoul, 03080
South Korea
Site 1205
Seoul, 03722
South Korea
Site 1204
Seoul, 06273
South Korea
Site 1201
Seoul, 06351
South Korea
Site 4201
Barcelona, 08028
Spain
Site 4205
Barcelona, 08041
Spain
Site 4202
Madrid, 28034
Spain
Site 4206
Madrid, 28040
Spain
Site 4203
Málaga, 29011
Spain
Site 4204
Vigo, 36212
Spain
Site 1301
Taichung, 40705
Taiwan
Site 1302
Taipei, 11217
Taiwan