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

Uterine Serous Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04814108
• Other study ID #: ZN-c3-004
• Status: Suspended
• Phase: Phase 2
• Start date: July 28, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2024
• Source: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 130
• Est. completion date: May 31, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Uterine Serous Carcinoma

Intervention

Drug:
• ZN-c3
ZN-c3 is an investigational drug.

Locations

Country	Name	City	State
Australia	Icon Cancer Centre- Chermside	Brisbane	Queensland
Australia	Mater Cancer Care Centre, Mater Misericordiae Limited	Brisbane	Queensland
Australia	Cabrini Hospital Malvern	Malvern	Victoria
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Northern Cancer Institute	St Leonards	New South Wales
Australia	Burnside War Memorial Hospital	Toorak Gardens	South Australia
Canada	Chu de Quebec-Universite	Quebec City	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Georgia	LTD High Technology Hospital Medcenter	Batumi	Republic Of Adjara
Georgia	Rustavi Clinic	Rustavi	Kvemo Kartli
Georgia	Acad. Fridon Todua Medical Center	Tbilisi
Georgia	LTD Innova Medical Center	Tbilisi
Georgia	LTD TIM-Tbilisi Innova of Medicine	Tbilisi
United States	Optimum Clinical Research Group- Women's Oncology	Albuquerque	New Mexico
United States	Alaska Women's Cancer Care	Anchorage	Alaska
United States	Maryland Oncology Hematology	Annapolis	Maryland
United States	Northside Hospital	Atlanta	Georgia
United States	Georgia Cancer Center at Augusta University	Augusta	Georgia
United States	Texas Oncology Austin	Austin	Texas
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Virginia Cancer Center	Charlottesville	Virginia
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Trihealth Cancer Institute	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Ohio State University James Cancer Hospital	Columbus	Ohio
United States	Willamette Valley Cancer Institute	Eugene	Oregon
United States	Texas Oncology Fort Worth Cancer Center	Fort Worth	Texas
United States	Corewell Health	Grand Rapids	Michigan
United States	Westchester Medical Center	Hawthorne	New York
United States	Texas Oncology Gulf Coast	Houston	Texas
United States	HCA Midwest Health Kansas City Research	Kansas City	Missouri
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Ascension St. Thomas Midtown Hospital	Nashville	Tennessee
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	University of Oklahoma Peggy and Charles Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	University of California Irvine Medical Center	Orange	California
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Honor Health	Phoenix	Arizona
United States	Northwest Cancer Specialists	Portland	Oregon
United States	Providence Portland Medical Center	Portland	Oregon
United States	Center of Hope	Reno	Nevada
United States	VCU Health System	Richmond	Virginia
United States	Texas Oncology San Antonio	San Antonio	Texas
United States	University of California San Francisco at Mission Bay	San Francisco	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	University of South Florida	Tampa	Florida
United States	Arizona Oncology Associates Wilmot HOPE	Tucson	Arizona
United States	Virginia Cancer Specialists	Warrenton	Virginia

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of TEAEs and incidence of dose modifications	To determine the safety and tolerability of ZN-c3 in subjects with recurrent or persistent USC.	2 years
Primary	Objective Response Rate as defined by the revised RECIST v1.1 as assessed by ICR	To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC	2 years
Secondary	Objective Response Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.	To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules	2 years
Secondary	Duration of Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.	To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules	2 years
Secondary	Progression Free Survival as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.	To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules	2 years
Secondary	Clinical Benefit Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.	To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules	2 years
Secondary	Time To Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.	To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules	2 years