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

Phase 2

Recruiting

• Conditions: Uterine Serous Carcinoma
• Interventions: Drug: ZN-c3

• Registration Number: NCT04814108
• Lead Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Brief 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).

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 Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Study Start: 2021-07-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2024-11-30
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZN-c3 Single Agent	ZN-c3	ZN-c3 (azenosertib) taken orally with food

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (52)

Revive Clinical Research; 🇺🇸 Sterling, Michigan, United States

Concord Repatriation General Hospital; 🇦🇺 Concord, New South Wales, Australia

Alaska Women's Cancer Care; 🇺🇸 Anchorage, Alaska, United States

Honor Health; 🇺🇸 Phoenix, Arizona, United States

Arizona Oncology Associates Wilmot HOPE; 🇺🇸 Tucson, Arizona, United States

University of California Irvine Medical Center; 🇺🇸 Orange, California, United States

University of California San Francisco at Mission Bay; 🇺🇸 San Francisco, California, United States

Mount Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States

Sarasota Memorial Hospital; 🇺🇸 Sarasota, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States

Georgia Cancer Center at Augusta University; 🇺🇸 Augusta, Georgia, United States

Maryland Oncology Hematology; 🇺🇸 Annapolis, Maryland, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

Corewell Health; 🇺🇸 Grand Rapids, Michigan, United States

HCA Midwest Health Kansas City Research; 🇺🇸 Kansas City, Missouri, United States

Center of Hope; 🇺🇸 Reno, Nevada, United States

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

Optimum Clinical Research Group- Women's Oncology; 🇺🇸 Albuquerque, New Mexico, United States

Westchester Medical Center; 🇺🇸 Hawthorne, New York, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Oncology Hematology Care; 🇺🇸 Cincinnati, Ohio, United States

Trihealth Cancer Institute; 🇺🇸 Cincinnati, Ohio, United States

Ohio State University James Cancer Hospital; 🇺🇸 Columbus, Ohio, United States

University of Oklahoma Peggy and Charles Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Willamette Valley Cancer Institute; 🇺🇸 Eugene, Oregon, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

Northwest Cancer Specialists; 🇺🇸 Portland, Oregon, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Ascension St. Thomas Midtown Hospital; 🇺🇸 Nashville, Tennessee, United States

Texas Oncology Austin; 🇺🇸 Austin, Texas, United States

Texas Oncology Fort Worth Cancer Center; 🇺🇸 Fort Worth, Texas, United States

Texas Oncology Gulf Coast; 🇺🇸 Houston, Texas, United States

Texas Oncology San Antonio; 🇺🇸 San Antonio, Texas, United States

VCU Health System; 🇺🇸 Richmond, Virginia, United States

University of Virginia Cancer Center; 🇺🇸 Charlottesville, Virginia, United States

Virginia Cancer Specialists; 🇺🇸 Warrenton, Virginia, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Northern Cancer Institute; 🇦🇺 St Leonards, New South Wales, Australia

Icon Cancer Centre- Chermside; 🇦🇺 Brisbane, Queensland, Australia

Mater Cancer Care Centre, Mater Misericordiae Limited; 🇦🇺 Brisbane, Queensland, Australia

Burnside War Memorial Hospital; 🇦🇺 Toorak Gardens, South Australia, Australia

Cabrini Hospital Malvern; 🇦🇺 Malvern, Victoria, Australia

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

Sir Charles Gairdner Hospital; 🇦🇺 Nedlands, Western Australia, Australia

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Chu de Quebec-Universite; 🇨🇦 Quebec City, Quebec, Canada

Rustavi Clinic; 🇬🇪 Rustavi, Kvemo Kartli, Georgia

LTD High Technology Hospital Medcenter; 🇬🇪 Batumi, Republic Of Adjara, Georgia

Acad. Fridon Todua Medical Center; 🇬🇪 Tbilisi, Georgia

LTD Innova Medical Center; 🇬🇪 Tbilisi, Georgia

LTD TIM-Tbilisi Innova of Medicine; 🇬🇪 Tbilisi, Georgia