Trial purpose
Cancer treatment
Tumor type
Gynaecological
Age
18+
Clinical summary
Summary
This is a Phase 2 open-label, multicenter study to evaluate the clinical activity, safety, pharmacokinetics (PK), and related biomarkers of ZN-c3 in adult women with recurrent or persistent uterine serous carcinoma (USC). All participants will receive ZN-c3.
Conditions
This trial is treating people with Uterine Serous Carcinoma
Eligibility
Inclusion
- Females ≥18 years of age at the time of informed consent.
-
Histologically confirmed recurrent or persistent USC for which no other proven effective treatment options are available or any available standard of care therapy was not tolerated or was refused by the subject.
- Subjects with endometrial carcinoma of mixed histology where the serous component comprises at least 5% of the tumor will be considered eligible.
- Subjects with carcinosarcomas (even if there is a serous component) are not eligible.
- Measurable disease per RECIST Guideline Version 1.1
-
Required prior therapy for endometrial cancer:
- Treatment with a platinum-based chemotherapy regimen.
- Treatment with a PD-(L)1 inhibitor
- Known HER2-positive tumors: Treatment with at least 1 HER2-targeted therapy, except for subjects who are not clinically eligible.
- Adequate hematologic and organ function
Exclusion
-
Any of the following treatment interventions within the specified time frame prior to C1D1:
- Major surgery within 28 days
- Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter).
- Radiation therapy within 21 days;
- Autologous or allogeneic stem cell transplant within 3 months.
- Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).
- Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, or CHK1/2 inhibitor for USC.
- A serious illness or medical condition(s) including, but not limited to: Any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1D1.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
K-Group Beta
Scientific Title
A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Adult Women With Recurrent or Persistent Uterine Serous Carcinoma
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