Actively Recruiting
A Phase 1b Study of ZN-c3 (Azenosertib) Combined With Chemotherapy or Bevacizumab in Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer
Led by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc · Updated on 2026-04-07
172
Participants Needed
24
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, early clinical effects, and how the body processes azenosertib (ZN-c3) when combined with other drugs in patients with advanced ovarian, peritoneal, or fallopian tube cancer. This Phase 1b open-label study includes patients with platinum-resistant or maintenance therapy contexts, aiming to understand dosing and treatment combinations better. The study has two parts: Part 1 assessed azenosertib with chemotherapy drugs including carboplatin, pegylated liposomal doxorubicin (PLD), paclitaxel, and gemcitabine in platinum-resistant cases. Part 2 explores azenosertib with bevacizumab as first- or second-line maintenance therapy after platinum chemotherapy. Dose escalation and expansion phases determine recommended doses and evaluate safety. Participants will receive study treatments in combination regimens and undergo regular assessments over about one year. Researchers monitor safety, side effects, and drug levels, aiming to find the maximum tolerated dose and recommended dosing. The study includes clinical evaluations, laboratory tests, and ongoing monitoring of patient response and tolerability throughout the study period.
CONDITIONS
Brief Title
A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects aged 18 years or older
- Histologically or cytologically confirmed FIGO Stage III/IV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma
- For Part 1: Received 1 or 2 prior therapy regimens in advanced or metastatic setting, including at least one cisplatin or carboplatin regimen
- Disease must be platinum-resistant (progression-free interval less than 6 months) or platinum refractory
- For Part 2 Dose Escalation: Received 6 cycles of platinum-based doublet chemotherapy in 1L or 2L setting as most recent therapy
- For Part 2 Dose Escalation: Response to prior platinum therapy with complete response, partial response, or stable disease in 1L; or specified progression and response criteria in 2L
- For Part 2 Dose Expansion: At least 4 cycles of 2L platinum-based chemotherapy with complete response, partial response, or stable disease
- For Part 2 Dose Expansion: Progression while on PARP inhibitor for 1L maintenance
- Adequate hematologic and organ function
- Additional protocol-defined inclusion criteria may apply
You will not qualify if you...
- Histology of abdominal adenocarcinoma of unknown origin or borderline ovarian tumor diagnosis
- Diagnosis of carcinosarcomas, even with serous component
- Serious illness or medical conditions interfering with participation
- Active, uncontrolled, or metastatic second malignancies requiring therapy
- Additional protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated cycles of 21 or 28 days, continuing up to approximately 1 year or until discontinuation
Participants receive azenosertib combined with chemotherapy (carboplatin, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine) or bevacizumab as maintenance therapy for advanced ovarian, peritoneal, or fallopian tube cancer.
Visits each cycle during treatment (cycles of 21 or 28 days)
Trial Site Locations
Total: 24 locations
1
Site 0264
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Site 0104
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Site 0111
St Louis, Missouri, United States, 53110
Actively Recruiting
4
Site 0173
New York, New York, United States, 10029
Actively Recruiting
5
Site 0259
Durham, North Carolina, United States, 27710
Actively Recruiting
6
Site 0191
Providence, Rhode Island, United States, 02905
Actively Recruiting
7
Site 0196
Nashville, Tennessee, United States, 37203
Completed
8
Site 0103
Houston, Texas, United States, 77030
Actively Recruiting
9
Site 2707
South Brisbane, Queensland, Australia, 4101
Completed
10
Site 2708
Sunshine Coast, Queensland, Australia, 4556
Completed
11
Site 2709
Adelaide, South Australia, Australia, 5000
Completed
12
Site 2716
Melbourne, Victoria, Australia, 3121
Actively Recruiting
13
Site 2706
Melbourne, Victoria, Australia, 3144
Actively Recruiting
14
Site 2705
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
15
Site 1001
Banja Luka, Bosnia and Herzegovina, 78000
Completed
16
Site 1002
Sarajevo, Bosnia and Herzegovina, 71000
Completed
17
Site 1003
Tuzla, Bosnia and Herzegovina, 75000
Completed
18
Site 1202
Panagyurishte, Bulgaria, 4500
Completed
19
Site 1201
Sofia, Bulgaria, 1632
Completed
20
Site 1401
Tbilisi, Georgia, 0112
Completed
21
Site 1902
Belgrade, Serbia, 11080
Completed
22
Site 2901
Busan, South Korea
Completed
23
Site 2903
Seoul, South Korea, 03080
Completed
24
Site 2904
Seoul, South Korea, 05505
Completed
Research Team
K
K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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