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Uterine Serous CarcinomaPhase 2NCT06369155

Azenosertib in Uterine Serous Carcinoma: Biomarker Study

A Phase 2 study testing Azenosertib in people with Uterine Serous Carcinoma and Uterine Carcinoma, run by Joyce Liu, MD at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This research study is being done to investigate how Azenosertib affects tumor cells of persistent or recurrent uterine serous carcinoma. The name of the study drug involved in this study is: -Azenosertib (a type of Wee1 inhibitor) Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Azenosertib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesUnited States
Study dates
5 Mar 2025to 31 Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have histologically or cytologically confirmed recurrent or persistent uterine serous carcinoma. For the purposes of this study, uterine carcinomas (with the exception of carcinosarcomas) that have any component that is considered serous will be considered a uterine serous carcinoma.
  • Participants must have measurable disease, defined as at least one lesion that can be accurately measured per RECIST 1.1 criteria. See Section 12 for the evaluation of measurable disease.
  • Participants must have had one prior platinum-based chemotherapy regimen for management of advanced or metastatic uterine serous carcinoma. Participants with early stage disease who received adjuvant platinum-based chemotherapy are also eligible if they recur within 12 months of their adjuvant therapy. Chemotherapy administered only in conjunction with primary RT as a radiosensitizer should not count as a systemic regimen. There is no restriction on the number of prior lines of therapy a participant may have previously received. Additionally, participants must have a known tumor MSI or MMR status and those participants with MSI-high or MMR-deficient tumors must have already received prior therapy with a PD1 or PD-L1 immune checkpoint inhibitor or be deemed not to be a candidate for immune checkpoint therapy.
  • Age 18 years or older. Because no dosing or adverse event data are currently available on the use of azenosertib in participants <18 years of age, children are excluded from this study.
  • ECOG performance status 0, 1, or 2 (see Appendix A)
  • Participants must meet the following organ and marrow function as defined below:
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  • absolute neutrophil count ≥1500/mcL
  • hemoglobin ≥9 g/dL (must be at least 2 weeks since any blood transfusion)
  • platelets ≥100,000/mcL
  • total bilirubin ≤ institutional upper limit of normal (ULN) or
  • ≤1.5x ULN in patients with liver metastases or well-documented Gilbert's Syndrome
  • AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN or ≤5 × institutional ULN in patients with liver metastases
  • creatinine ≤ 1.5x institutional ULN or estimated CrCl≥ 60 mL/min
  • Willingness to release archival tissue for research purposes.
  • Biopsiable disease in a lesion that is not being utilized as the target lesion for RECIST assessment and willing to undergo pre- and on-treatment biopsies.
  • HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. However, participants who are on antiretroviral therapy that includes strong inhibitors or inducers of CYP3A4 are not eligible, given the potential for interaction with azenosertib, which is a CYP3A4 substrate.
  • Participants with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression. Participants with new or progressive brain metastases (active brain metastases) are eligible only if the treating physician determines that immediate CNS-specific treatment is not required and is unlikely to be required during the first two cycles of therapy. Participants with known leptomeningeal disease are not eligible.
  • Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • The effects of azenosertib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Participants who have had chemotherapy, radiotherapy, or investigational therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to first dose of azenosertib. Participants may not have had hormonal therapy within 2 weeks of the first dose of azenosertib.
  • Participants who have not recovered from adverse events due to prior anti-cancer therapy administered more than 3 weeks before first dose of azenosertib (e.g.,., have residual toxicities > Grade 1) with the exception of alopecia.
  • Participants who are receiving any other investigational agents for this condition.
  • Participants may not have had prior receipt of a cell cycle checkpoint inhibitor (e.g., Chek1, Wee1, or ATR inhibition)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to azenosertib.
  • Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine.
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  • Pregnant women are excluded from this study because azenosertib is an DNA damage repair pathway agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with azenosertib, breastfeeding should be discontinued if the mother is treated with azenosertib.
  • --Women of childbearing potential (WoCBP) may be included only if acceptable contraception (see Appendix C) is in place for two weeks before study entry, for the duration of the treatment with the study drug and for 5x half-lives of ZN-c3 + 6 months after the last dose of ZN-c3. Sexually active female subjects of childbearing potential must agree to use protocol-recommended method of contraception from the start of the screening period until 6 months after the last dose of study drug ZN-c3.
  • Participants must not have undergone major surgical procedures within 28 days of beginning study treatment or minor surgical procedures within 7 days of beginning study treatment. Port-a-cath placement will be allowed within a 7 day window of starting study treatment.
  • Participants must be able to swallow oral medication and may not have refractory nausea and vomiting, have a percutaneous endoscopic gastrostomy (PEG) tube, be receiving total parenteral nutrition (TPN), or be dependent on IV fluid support.
  • Because the composition, PK, and metabolism of many herbal supplements are unknown, the concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, cannabis, St. John's wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, and ginseng). Participants should stop herbal medications at least 7 days prior to first dose of azenosertib.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Joyce Liu, MD, MPH contact

617-632-5269

Joyce_Liu@DFCI.HARVARD.EDU

United States2 sites, 2 recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215

    Joyce Liu, MD, MPH, 617-632-5269, joyce_liu@dfci.harvard.edu

    Joyce Liu, MD, MPH

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Joyce Liu, MD, MPH, 617-632-5269, joyce_liu@dfci.harvard.edu

    Joyce Liu, MD, MPH

    Recruiting

Other trials in United States

About this study

Official title: A Biomarker Study of the Wee1 Inhibitor Azenosertib (ZN-c3) in Women With Recurrent or Persistent Uterine Serous Carcinoma

This research study is being done to investigate how Azenosertib affects tumor cells of persistent or recurrent uterine serous carcinoma.

The name of the study drug involved in this study is:

-Azenosertib (a type of Wee1 inhibitor)

Read the detailed description

This research study is being done to investigate how Azenosertib affects tumor cells of persistent or recurrent uterine serous carcinoma. Azenosertib has been tested as a treatment for other diseases and has shown to stop cancer cell growth.

The U.S. Food and Drug Administration (FDA) has not approved Azenosertib as a treatment for recurrent uterine serous carcinoma.

This research study involves screening for eligibility, study treatment visits, X-rays, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography CT (PET-CT) scans, Meta-iodobenzylguanidine (MIBG) scans, Fluorodeoxyglucose Positron Emission Tomography), (FDG-PET) scans, Electrocardiograms (EKGs), tumor biopsies, and blood tests.

It is expected that about 25 people will take part in this research study.

Zentalis Pharmaceuticals is supporting this research study by providing the study drug Azenosertib.

Being tested
Azenosertib
Keywords
Uterine Serous Carcinoma, Uterine Carcinoma, Uterine Cancer, Persistent Uterine Serous Carcinoma
Medical subject headings
Uterine Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzenosertibDrug

    Also called Zn-c3, C29H34N8O2

    Wee1 inhibitor, 25mg and 100mg tablets, taken orally per protocol.

Study groups in NCT06369155
Study groupRoleWhat they receive
AzenosertibExperimental25 participants will be enrolled and will complete study procedures as follows: * Baseline visit with assessments and CT or MRI scan. * CT or MRIs scans every 2 cycles. * Cycle 1 through End of Treatment: --Days 1 through 5, 8 through 12, and 15 through 19: Predetermined dose of Azenosertib 1x daily. * End of Treatment visit.
Receives: Drug: Azenosertib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Change in Replication Fork Speed in Overall Response

    Replication fork speed assessed by DNA fiber assays in PDO models. Responder defined as participants achieving complete response (CR) or partial response (PR) based on RECISTv1.1 criteria. Wilcoxon rank sum tests will be used to compare the percentage change in replication fork speed with exposure to WEE1 inhibition in co-clinical models between overall response responder and non-responder.

    Measured: Up to 7 months

  2. Percentage Change in Replication Fork Speed in 6 Month Progression Free Survival (PFS6)

    Replication fork speed assessed by DNA fiber assays in PDO models. PFS6 is a binary endpoint where patients that are alive and progression free (per RECIST 1.1) at 6 months are considered responders. All other patients (those that died or progressed prior to 6 months or those with less than 6 months of follow-up for progression) are considered non-responders. Wilcoxon rank sum tests will be used to compare the percentage change in replication fork speed with exposure to WEE1 inhibition in co-clinical models between overall response responder and non-responder.

    Measured: At 6 months

Secondary outcomes (6)

  1. Overall Response Rate (ORR)

    The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECISTv1.1 criteria.

    Measured: Up to 7 months

  2. 6-month Progression-Free Survival (PFS6)

    6-month PFS is a probability estimated using progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last disease assessment.

    Measured: At 6 months

  3. Clinical Benefit Rate (CBR)

    CBR defined as proportion of participants with Partial Response (PR) + Complete Response (CR) + Stable Disease (SD) ≥6 months per RECIST 1.1

    Measured: Up to 7 months

  4. Median Duration of Overall Response (DOR)

    Duration of Overall Response (DOR), estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) per RECISTv1.1, until the first date that recurrent or progressive disease is objectively documented. Participants without progressive disease are censored at the date of last disease assessment.

    Measured: Up to 7 months

  5. Median Progression-Free Survival (PFS)

    Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last disease assessment.

    Measured: 2 years

  6. Grade 3-5 Treatment-related Toxicity Rate

    All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.

    Measured: Up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2024
  2. Study start5 Mar 2025
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06369155
Sponsor's protocol ID
24-061
Status last verified
Feb 2026
First submitted
12 Apr 2024
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azenosertib in people with Uterine Serous Carcinoma and Uterine Carcinoma, run by Joyce Liu, MD at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joyce Liu, MD, MPH (617-632-5269, Joyce_Liu@DFCI.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change in Replication Fork Speed in Overall Response (time frame: Up to 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06369155.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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