A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma

May 1, 2024 updated by: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Withdrawn
        • Concord Repatriation General Hospital
      • St Leonards, New South Wales, Australia, 2065
        • Active, not recruiting
        • Northern Cancer Institute
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Mater Cancer Care Centre, Mater Misericordiae Limited
        • Contact:
          • Catherine Shannon, MD
          • Phone Number: 0731636166
        • Principal Investigator:
          • Catherine Shannon, MD
      • Brisbane, Queensland, Australia, 4032
        • Recruiting
        • Icon Cancer Centre- Chermside
        • Principal Investigator:
          • Jeffrey Goh, MD
        • Contact:
          • Jesse Peet
          • Phone Number: +61 7 3737 4539
    • South Australia
      • Toorak Gardens, South Australia, Australia, 6065
        • Active, not recruiting
        • Burnside War Memorial Hospital
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Recruiting
        • Cabrini Hospital Malvern
        • Principal Investigator:
          • Gary Richardson, MD
        • Contact:
          • Leyna Tran
          • Phone Number: +61395083414
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Principal Investigator:
          • George Au-Yeung, MD
        • Contact:
          • Xiaoyi Mackenzie
          • Phone Number: +61385595000
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Sir Charles Gairdner Hospital
        • Principal Investigator:
          • Tarek Meniawy, MD
        • Contact:
          • Jolanta Damas
          • Phone Number: (08) 6383 3182
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Active, not recruiting
        • Sunnybrook Health Sciences Centre
    • Quebec
      • Quebec City, Quebec, Canada, G1R 3S1
        • Active, not recruiting
        • Chu de Quebec-Universite
  • Georgia
      • Tbilisi, Georgia, 0112
        • Active, not recruiting
        • Acad. Fridon Todua Medical Center
      • Tbilisi, Georgia, 0144
        • Active, not recruiting
        • LTD Innova Medical Center
      • Tbilisi, Georgia, 0160
        • Active, not recruiting
        • LTD TIM-Tbilisi Innova of Medicine
    • Kvemo Kartli
      • Rustavi, Kvemo Kartli, Georgia, 3700
        • Active, not recruiting
        • Rustavi Clinic
    • Republic Of Adjara
      • Batumi, Republic Of Adjara, Georgia, 6000
        • Active, not recruiting
        • LTD High Technology Hospital Medcenter
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Alaska Women's Cancer Care
        • Principal Investigator:
          • Melissa Hardesty
        • Contact:
          • Andrea Castelblanco
          • Phone Number: 907-212-6871
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Honor Health
        • Contact:
          • Lyndsay Willmott
          • Phone Number: 602-277-4868
        • Contact:
          • Kelly Fillbrandt
          • Phone Number: 602-277-4868
        • Principal Investigator:
          • Lyndsey Willmott, MD
      • Tucson, Arizona, United States, 85711
        • Recruiting
        • Arizona Oncology Associates Wilmot HOPE
        • Principal Investigator:
          • Joseph Buscema, MD, PhD
        • Contact:
          • Stacey Kimbell
          • Phone Number: 520-668-5678
        • Contact:
          • Julie Klinker
          • Phone Number: 520-269-3821
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine Medical Center
        • Principal Investigator:
          • Krishnansu Tewari, MD
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco at Mission Bay
        • Principal Investigator:
          • Lee-may Chen, MD
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center
        • Principal Investigator:
          • Brian Slomovitz, MD
        • Contact:
          • Ana Lacombe, BA, MBA
          • Phone Number: 305-674-2625
        • Contact:
          • Yvonne Enriquez
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Hospital
        • Principal Investigator:
          • Beverly Long, MD
        • Contact:
          • Angele Price, BSN, RN
          • Phone Number: 3614 941-917-2225
        • Contact:
          • Kristen McKenzie, BSN, RN
          • Phone Number: 1211 941-917-2225
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Principal Investigator:
          • Matthew Anderson, MD
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Northside Hospital
        • Principal Investigator:
          • Meaghan Tenney, MD
        • Contact:
          • Meaghan Tenney, MD
          • Phone Number: 404-303-3355
        • Contact:
          • Northside Hospital - Central Research Department
          • Phone Number: 404-303-3355
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Georgia Cancer Center at Augusta University
        • Principal Investigator:
          • Sharad Ghamande, MD
        • Contact:
          • Emily Sarria, BSN, RN
          • Phone Number: 706-721-5557
        • Contact:
          • Sara Mobley, BSN, RN
          • Phone Number: 706-721-5557
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Recruiting
        • Maryland Oncology Hematology
        • Principal Investigator:
          • Jeanine Werner, MD
        • Contact:
          • Teresa Saavedra
          • Phone Number: 5033 240-223-1811
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Medical Center
        • Contact:
          • Shelby Fragetta
          • Phone Number: 410-328-4827
        • Contact:
          • Kristyn Poopert
          • Phone Number: 410-328-2277
        • Principal Investigator:
          • Dana Roque, MD
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health
        • Contact:
          • Esther Peariso
          • Phone Number: 616-486-0358
        • Principal Investigator:
          • Gregory Gressel, MD
      • Sterling, Michigan, United States, 48659
        • Withdrawn
        • Revive Clinical Research
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Recruiting
        • HCA Midwest Health Kansas City Research
        • Contact:
          • Megan Werner
          • Phone Number: 816-276-3852
        • Contact:
          • Lauren Babcock
          • Phone Number: 816-276-4297
        • Principal Investigator:
          • Kristopher Lybarger, MD
    • Nevada
      • Reno, Nevada, United States, 89511
        • Recruiting
        • Center Of Hope
        • Principal Investigator:
          • Peter Lim, MD
        • Contact:
          • Shannon Pierpoint, OCN CRC
          • Phone Number: 775-327-4673
        • Contact:
          • Reyna Vanderkelen
          • Phone Number: 775-327-4673
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Principal Investigator:
          • Eugenia Girda, MD
        • Contact:
          • Kelly Gruber
          • Phone Number: 732-258-8453
        • Contact:
          • Khadijah Abass
          • Phone Number: 732-258-8081
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • Optimum Clinical Research Group- Women's Oncology
        • Principal Investigator:
          • Karen Finkelstein, MD
        • Contact:
          • Milena Overby
          • Phone Number: 505-372-4270
        • Contact:
          • Phone Number: 832-367-0495
    • New York
      • Hawthorne, New York, United States, 10532
        • Recruiting
        • Westchester Medical Center
        • Contact:
          • Allyson Pulsoni
          • Phone Number: 914-493-6610
        • Principal Investigator:
          • Tana Pradhan, DO
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati
        • Principal Investigator:
          • Caroline Billingsley, MD
        • Contact:
          • Jessica Mullins
          • Phone Number: 513-584-7698
        • Contact:
          • Margan Harris
          • Phone Number: 513-584-7698
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Oncology Hematology Care
        • Principal Investigator:
          • Ajit Gubbi, MD
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Trihealth Cancer Institute
        • Principal Investigator:
          • Robert Neff, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University James Cancer Hospital
        • Contact:
          • Sainath Koth
          • Phone Number: 614-688-8845
        • Principal Investigator:
          • Floortje Backes, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Peggy and Charles Stephenson Cancer Center
        • Principal Investigator:
          • Debra Richardson, MD
        • Contact:
          • Christine Pappaterra
          • Phone Number: 405-271-8707
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Willamette Valley Cancer Institute
        • Principal Investigator:
          • Charles Anderson, MD
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Christopher Darus, MD
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Northwest Cancer Specialists
        • Principal Investigator:
          • Erin Salinas, MD
        • Contact:
          • Jennifer Thompson, RN
          • Phone Number: 971-708-7600
        • Contact:
          • Elaine Bigler, RN
          • Phone Number: 503-239-7767
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Hospital
        • Principal Investigator:
          • Enrique Hernandez, MD
        • Contact:
          • Sarmina Hassan, MBBS., PhD
          • Phone Number: 267-473-0235
        • Contact:
          • Christine Benckert, RN
          • Phone Number: 215-707-1385
    • Tennessee
      • Nashville, Tennessee, United States, 37236
        • Recruiting
        • Ascension St. Thomas Midtown Hospital
        • Principal Investigator:
          • Michael Stany, MD
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Oncology Austin
        • Principal Investigator:
          • Lynne Knowles, MD
        • Contact:
          • Michelle Owens, RN, OCN
          • Phone Number: 937-572-8332
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Texas Oncology Fort Worth Cancer Center
        • Principal Investigator:
          • Noelle Cloven, MD
      • Houston, Texas, United States, 77089
        • Recruiting
        • Texas Oncology Gulf Coast
        • Contact:
          • Christina Genthon, BSN
          • Phone Number: 832-616-5113
        • Contact:
          • Sandra Thornton, RN, MSN
          • Phone Number: 831-616-5101
        • Principal Investigator:
          • Christine M. Lee, MD
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology San Antonio
        • Contact:
          • Debbie Ponce
          • Phone Number: 210-595-5692
        • Contact:
          • Shannon Syring, RN ONC CCRC
          • Phone Number: 210-424-1600
        • Principal Investigator:
          • Joseph De La Garza, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Cancer Center
        • Principal Investigator:
          • Linda Duska, MD
        • Contact:
          • Hannah Snow, RN, BSN
          • Phone Number: 434-982-4110
        • Contact:
          • Jungeun Kim, PhD
          • Phone Number: 434-243-8109
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Health System
        • Principal Investigator:
          • Leslie Randall, MD
        • Contact:
          • Melanie Hamilton
          • Phone Number: 804-628-6430
      • Warrenton, Virginia, United States, 20186
        • Recruiting
        • Virginia Cancer Specialists
        • Principal Investigator:
          • Robert Marsh, MD
        • Contact:
          • Carrie Friedman, RN, BSN, OCN
          • Phone Number: 703-636-1473
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • William Bradley, MD
        • Contact:
          • Subarna Paul
          • Phone Number: 414-805-8594

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA

  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

EXCLUSION CRITERIA

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ZN-c3 Single Agent
ZN-c3 (azenosertib) taken orally with food
Drug: ZN-c3
ZN-c3 is an investigational drug.
Other Names:
  • azenosertib
  • KP-2638

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency and severity of TEAEs and incidence of dose modifications
Time Frame: 2 years
To determine the safety and tolerability of ZN-c3 in subjects with recurrent or persistent USC.
2 years
Objective Response Rate as defined by the revised RECIST v1.1 as assessed by ICR
Time Frame: 2 years
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Time Frame: 2 years
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
2 years
Duration of Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Time Frame: 2 years
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
2 years
Progression Free Survival as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Time Frame: 2 years
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
2 years
Clinical Benefit Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Time Frame: 2 years
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
2 years
Time To Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Time Frame: 2 years
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Investigators

  • Study Director: Project Director, K-Group Beta (A wholly owned subsidiary of Zentalis Pharmaceuticals)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2021

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZN-c3-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Serous Carcinoma

Clinical Trials on ZN-c3

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe