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Recruiting Phase 2

A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

NCT05128825 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2022-02-17
Last updated
2026-09-29

Condition(s) studied

High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Investigational drug(s) / intervention(s)

azenosertib →

azenosertib: Azenosertib (ZN-c3) will be administered orally.

Study summary

This is a multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose tumors are Cyclin E1 positive as determined by central review using the Sponsor's investigational clinical trial assay.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18 years 2. High-grade serous ovarian, fallopian tube or primary peritoneal cancer 3. Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status result determined by IHC using the Sponsor's investigational clinical trial assay 4. Prior therapy: 1. Subjects must have platinum-resistant disease 2. Part 2c: Subjects with PROC may have 1 to 4 prior lines or regimens. Prior treatment in this cohort includes a weekly taxane regimen, either as single agent or in combination, per protocol 3. Prior bevacizumab treatment is required, if eligible per standard of care 4. Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if eligible per standard of care 5. Prior mirvetuximab treatment is required, if eligible per standard of care 5. Measurable disease per RECIST Version 1.1. 6. Adequate hematologic and organ function, as defined in protocol 7. ECOG 0-1 Exclusion Criteria: 1. Primary platinum-refractory disease 2. Subjects with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, low-grade, borderline, or other ovarian tumors 3. Any of the following treatment interventions within the specified time frame prior to C1D1: 1. Major surgery within 28 days 2. Hospitalization within 14 days 3. Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter); 4. Radiation therapy within 21 days; 5. Autologous or allogeneic stem cell transplant within 3 months. 6. Current use of any other investigational drug therapy \<28 days or 5 half-lives (whichever is shorter). 7. Inability to discontinue treatment prescription or non-prescription drugs, or to discontinue consumption of food and herbal supplements that are strong or moderate CYP3A inhibitors and inducers or P-gp inhibitors at least 14 days prior to C1D1. 4. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1 inhibitor, or CHK1/2 inhibitor. 5. A serious illness or medical condition(s) including, but not limited to: 1. Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible. 2. Myocardial impairment resulting in heart failure (NYHA Class II-IV) 3. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or may interfere with interpretation of study results 4. Acute kidney injury requiring intervention or intravenous fluid in the last 14 days or presence of indwelling urinary catheter or percutaneous nephrostomy. 5. Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for intravenous alimentation, active peptic ulcer, chronic diarrhea or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption. 6. Active, uncontrolled infection. Subjects with an infection receiving treatment (antibiotic, antifungal, or antiviral) must have completed such treatment and the infection must be considered controlled/resolved (and afebrile) by the Investigator for at least 7 days before C1D1 7. Any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (CT scan, recent hospitalization for small bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1D1. 6. Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia, or skin pigmentation). 7. Pregnant or lactating female subject or female subject of childbearing potential who has a positive serum pregnancy test within 14 days prior to C1D1. 8. History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free. Exceptions include appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, or other malignancies with an expected curative outcome. 9. Subjects who are known to be immunocompromised or HIV-positive on highly active anti-retroviral therapy. 10. Subjects with known active hepatitis B or hepatitis C infection. 11. Individuals who are judged by the Investigator to be unsuitable as study subjects. 12. Subjects who had prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.

Primary outcome measure(s)

  • Objective Response Rate (ORR) defined by RECIST v1.1 [Part 2] — Up to approximately 12 months from the enrollment of the last subject
    Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.

Trial sites (86)

FacilityCityRegionStatus
Site 0170-USA Mitchell Cancer Institute Mobile Alabama Recruiting
Site 0143 - HonorHealth Phoenix Arizona Recruiting
Site 0102 - University of Arizona Cancer Center Tucson Arizona Recruiting
Site 0258 - UC San Diego Moores Cancer Center La Jolla California Active Not Recruiting
Site 0287 - Ridley Tree Cancer Center Santa Barbara California Active Not Recruiting
Site 0135 - Rocky Mountain Cancer Centers Lone Tree Colorado Recruiting
Site 0158 - Hartford HealthCare Hartford Connecticut Recruiting
Site 0241 - Florida Cancer Specialist - North Altamonte Springs Florida Recruiting
Site 0173 - Mount Sinai Medical Center Miami Beach Florida Recruiting
Site 0308 - Advent Health Orlando Florida Recruiting
Site 0239 - Florida Cancer Specialists - East Wellington Florida Recruiting
Site 0108 - Emory University Hospital Atlanta Georgia Recruiting
Site 0236 - Memorial Health Savannah Georgia Active Not Recruiting
Site 0324 - Illinois Cancer Specialists Niles Illinois Active Not Recruiting
Site 0284 - Community Cancer Center North Indianapolis Indiana Recruiting
Site 0217 - St Vincent Hospital and Health Care Centers Indianapolis Indiana Recruiting
Site 0251 - Norton Cancer Institute Louisville Kentucky Recruiting
Site 0146 - Maryland Oncology Hematology, PA Rockville Maryland Active Not Recruiting
Site 0221 - Tufts Medical Center - PPDS Boston Massachusetts Recruiting
Site 0104 - Dana Farber Cancer Institute Boston Massachusetts Recruiting
Site 0307 - Lahey Hospital and Medical Center Burlington Massachusetts Recruiting
Site 0263 - Baystate Medical Center Springfield Massachusetts Recruiting
Site 0101 - Barbara Ann Karmanos Cancer Institute Detroit Michigan Recruiting
Site 0228 - Corewell Health Medical Group West Grand Rapids Michigan Recruiting
Site 0288 - Minnesota Oncology Hematology - Maplewood Maplewood Minnesota Recruiting
Site 0226 - CoxHealth Springfield Missouri Active Not Recruiting
Site 0317 - Nebraska Methodist Hospital Omaha Nebraska Active Not Recruiting
Site 0213 - Center of Hope Reno Nevada Recruiting
Site 0231 - Northwell Health Cancer Institute Manhasset New York Active Not Recruiting
Site 0126 - Wilmot Cancer Center Rochester New York Recruiting
Site 0259 - Duke Cancer Center Durham North Carolina Recruiting
Site 0147 - Trihealth Cancer Institute - Harold and Eugen Cincinnati Ohio Recruiting
Site 0243 - Mark H Zangmeister Cancer Center Columbus Ohio Recruiting
Site 0214-Ohio State University Comprehensive Cancer Center Hilliard Ohio Recruiting
Site 0316 - Willamette Valley Cancer Institute/Oncology Associates of Oregon Eugene Oregon Recruiting
Site 0232 - University of Pennsylvania Philadelphia Pennsylvania Recruiting
Site 0178 - Thomas Jefferson University Philadelphia Pennsylvania Recruiting
Site 0277 - Alliance Cancer Specialist, PC Wynnewood Pennsylvania Active Not Recruiting
Site 0132 - Avera Cancer Institute Sioux Falls South Dakota Recruiting
Site 0103 - University of Texas MD Anderson Cancer Center Houston Texas Recruiting

+ 46 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05128825 on ClinicalTrials.gov ↗ ← All trials in Italy