Actively Recruiting
A Biomarker Study of the Wee1 Inhibitor Azenosertib (ZN-c3) in Women With Recurrent or Persistent Uterine Serous Carcinoma
Led by Joyce Liu, MD · Updated on 2026-03-02
25
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
J
Joyce Liu, MD
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how the drug Azenosertib affects tumor cells in women with persistent or recurrent uterine serous carcinoma, a type of uterine cancer. This Phase 2 study is sponsored by Dr. Joyce Liu and supported by Zentalis Pharmaceuticals. The study focuses on investigating Azenosertib, a Wee1 inhibitor, which has shown the ability to stop cancer cell growth in other diseases but is not yet FDA-approved for this condition. Participants will receive Azenosertib orally in cycles, taking the drug on days 1 through 5, 8 through 12, and 15 through 19 of each cycle. The study includes about 25 women and involves baseline assessments, CT or MRI scans every two cycles, and an end-of-treatment visit. Biopsies and various imaging scans such as PET-CT, MIBG, and FDG-PET will be performed to monitor disease and treatment effects. During the study, participants will undergo tumor biopsies, blood tests, electrocardiograms, and multiple imaging procedures including CT, MRI, and several specialized scans. Researchers will measure changes in tumor cell replication speed and progression-free survival up to seven months, along with other outcomes such as overall response rate and treatment-related toxicities. The study period includes screening, treatment, and follow-up visits to closely monitor participants' health and treatment effects.
CONDITIONS
Brief Title
Azenosertib in Uterine Serous Carcinoma: Biomarker Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed recurrent or persistent uterine serous carcinoma
- Measurable disease with at least one lesion measurable by RECIST 1.1 criteria
- Prior platinum-based chemotherapy for advanced or metastatic uterine serous carcinoma
- Age 18 years or older
- ECOG performance status 0, 1, or 2
- Adequate organ and marrow function as specified
- Willingness to provide archival tissue for research
- Biopsiable disease and willingness to undergo pre- and on-treatment biopsies
- HIV-infected participants on stable antiretroviral therapy with undetectable viral load may participate
- Participants with treated brain metastases stable on imaging may participate
- Prior or concurrent malignancies allowed if they do not interfere with study assessments
- Use of adequate contraception for women of childbearing potential and men
- Ability to understand and sign informed consent
You will not qualify if you...
- Chemotherapy, radiotherapy, or investigational therapy within 3 weeks prior to first dose of Azenosertib
- Hormonal therapy within 2 weeks prior to first dose
- Unrecovered adverse events from prior anticancer therapy (except alopecia) above Grade 1
- Receiving other investigational agents for this condition
- Prior treatment with cell cycle checkpoint inhibitors (e.g., Chek1, Wee1, ATR inhibitors)
- History of allergic reactions to similar compounds as Azenosertib
- Use of medications that strongly inhibit or induce CYP3A4
- Pregnant or breastfeeding women
- Major surgery within 28 days or minor surgery within 7 days before study treatment
- Inability to swallow oral medication or dependence on IV nutrition
- Use of herbal supplements within 7 days prior to first dose
- Cardiac disease history with New York Heart Association class worse than 2B or prior cardiotoxic treatments
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 - Up to 7 months
Participants receive the study drug Azenosertib orally on specific days in each cycle while undergoing scheduled scans and assessments.
Baseline visit; treatment days 1-5, 8-12, and 15-19 of each cycle; CT or MRI scans every 2 cycles; end of treatment visit
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
J
Joyce Liu, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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