Summary

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

Description

Summary

A Phase 2 study to evaluate the clinical activity, safety, and potentially predictive biomarker profile of ZN-c3 in subjects with High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Official Title

A Phase 2 Open-Label, Multicenter Study To Evaluate Efficacy And Safety Of ZN-c3 In Subjects With High-Grade Serous Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer (ZN-c3-005/GOG-3066/DENALI)

Details

A Phase 2 study to evaluate the clinical activity, safety, and potentially predictive biomarker profile of ZN-c3 in subjects with High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age ≥18 years
  2. High-grade serous ovarian cancer
  3. Prior therapy:
    1. Subjects must have platinum-resistant disease
    2. One to 4 prior lines or regimens are allowed (1 to 5 prior lines are permitted in part 1b)
    3. Prior bevacizumab treatment is required
  4. Measurable disease per RECIST Version 1.1.
  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.
  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 C1 D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1 D1.

Locations

  • Site 0124 - University of California Irvine accepting new patients
    Orange California 92697 United States
  • Site 0287 - Ridley Tree Cancer Center accepting new patients
    Santa Barbara California 93105 United States

Lead Scientist at UC Irvine

  • Krishnansu Tewari
    Professor, Obstetrics and Gynecology, School of Medicine. Authored (or co-authored) 231 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
NCT05128825
Phase
Phase 2 Peritoneal Cancer Research Study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated