Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around
Principal Investigator
by Krishnansu Tewari, MD
Headshot of Krishnansu Tewari
Krishnansu Tewari

Description

Summary

This is a Phase 2 study to evaluate the clinical activity and safety of ZN-c3 (azenosertib) in adult women with recurrent or persistent uterine serous carcinoma (USC).

Official 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

Details

This is a Phase 2 open-label, multicenter study to evaluate the clinical activity and safety of ZN-c3 (also known as azenosertib; KP-2638) in adult women with recurrent or persistent uterine serous carcinoma (USC).

Keywords

Uterine Serous Carcinoma, uterus, uterine, endometrial, endometrium, serous carcinoma, wee1, Wee-1, usc, serous, Carcinoma, Serous Cystadenocarcinoma, ZN-c3 Single Agent

Eligibility

You can join if…

Open to females ages 18 years and up

  1. Females ≥18 years of age at the time of informed consent.
  2. 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.
  3. Measurable disease per RECIST Guideline Version 1.1
  4. Required prior therapy for endometrial cancer:
    1. Treatment with a platinum-based chemotherapy regimen.
    2. Treatment with a PD-(L)1 inhibitor
    3. Known HER2-positive tumors: Treatment with at least 1 HER2-targeted therapy, except for subjects who are not clinically eligible.
  5. Adequate hematologic and organ function

You CAN'T join if...

  1. Any of the following treatment interventions within the specified time frame prior to

    C1D1:

    1. Major surgery within 28 days
    2. Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter).
    3. Radiation therapy within 21 days;
    4. Autologous or allogeneic stem cell transplant within 3 months.
    5. Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).
  2. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, or CHK1/2 inhibitor for USC.
  3. 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.

Locations

  • University of California Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • Honor Health accepting new patients
    Phoenix Arizona 85016 United States

Lead Scientist at UC Irvine

  • Krishnansu Tewari, MD
    Professor, Obstetrics and Gynecology, School of Medicine. Authored (or co-authored) 233 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
ID
NCT04814108
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 130 study participants
Last Updated