A Study of ZN-c3 in Subjects With High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Phase 2

Active, not recruiting

• Conditions: High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
• Interventions: Drug: ZN-c3

• Registration Number: NCT05128825
• Lead Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Brief 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

Detailed Description

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

Study Timeline

• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-22
• Study Start: 2022-02-17
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-25
• Primary Completion: 2025-04-30
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

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

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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.

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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label with ZN-c3 (also known as azenosertib)	ZN-c3	ZN-c3 (azenosertib) taken orally with food

Primary Outcome Measures

Name	Time	Method
Frequency of TEAEs	Cycle 1 Day 1 until 30 days after treatment discontinuation	To investigate the safety and tolerability of ZN-c3 in subjects with PROC
Severity of TEAEs	Cycle 1 Day 1 until 30 days after treatment discontinuation	To investigate the safety and tolerability of ZN-c3 in subjects with PROC
Incidence of dose modifications	Cycle 1 Day 1 until 30 days after treatment discontinuation	To investigate the safety and tolerability of ZN-c3 in subjects with PROC
Overall Response Rate defined by the revised RECIST v1 .1. and assessed by ICR.	Every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months	To investigate the antitumor activity of ZN-c3 in subjects with PROC

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate as defined by the revised RECIST v1 .1. and assessed by ICR and the Investigator.	Every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months	To further investigate the antitumor activity of ZN-c3 in subjects with PROC
Duration of Response as defined by the revised RECIST v1 .1. and assessed by ICR and the Investigator.	Every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 60 months	To further investigate the antitumor activity of ZN-c3 in subjects with PROC
Progression Free Survival as defined by the revised RECIST v1 .1. and assessed by ICR and the Investigator.	Every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months	To further investigate the antitumor activity of ZN-c3 in subjects with PROC
Clinical Benefit Rate as defined by the revised RECIST v1 .1. and assessed by ICR and the Investigator.	Every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months	To further investigate the antitumor activity of ZN-c3 in subjects with PROC
Time To Response as defined by the revised RECIST v1 .1. and assessed by ICR and the Investigator.	Every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months	To further investigate the antitumor activity of ZN-c3 in subjects with PROC

Trial Locations

Locations (59)

Site 0287 - Ridley Tree Cancer Center; 🇺🇸 Santa Barbara, California, United States

Site 0307 - Lahey Hospital and Medical Center; 🇺🇸 Burlington, Massachusetts, United States

Site 0231 - Northwell Health Cancer Institute; 🇺🇸 Manhasset, New York, United States

Site 0243 - Mark H Zangmeister Cancer Center; 🇺🇸 Columbus, Ohio, United States

Site 0232 - University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Site 0142 - Texas Oncology - Baylor Charles A. Sammons Cancer Center; 🇺🇸 Dallas, Texas, United States

Site 0259 - Duke Cancer Center; 🇺🇸 Durham, North Carolina, United States

Site 0147 - Trihealth Cancer Institute - Harold and Eugen; 🇺🇸 Cincinnati, Ohio, United States

Site 0143 - HonorHealth; 🇺🇸 Phoenix, Arizona, United States

Site 0318 - Utah Cancer Specialists; 🇺🇸 Salt Lake City, Utah, United States

Site 0159 - North Shore University Health System; 🇺🇸 Evanston, Illinois, United States

Site 0135 - Rocky Mountain Cancer Centers; 🇺🇸 Lone Tree, Colorado, United States

Site 0236 - Memorial Health; 🇺🇸 Savannah, Georgia, United States

Site 0173 - Mount Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States

Site 0258 - UC San Diego Moores Cancer Center; 🇺🇸 La Jolla, California, United States

Site 0239 - Florida Cancer Specialists - East; 🇺🇸 Daytona Beach, Florida, United States

Site 0310 - St. Louis Cancer Care LLP; 🇺🇸 Bridgeton, Missouri, United States

Site 0275 - Valley Hospital; 🇺🇸 Paramus, New Jersey, United States

Site 0263 - Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

Site 0288 - Minnesota Oncology Hematology - Maplewood; 🇺🇸 Maplewood, Minnesota, United States

Site 0157 - Mercy Hospital Saint Louis; 🇺🇸 Saint Louis, Missouri, United States

Site 0176 - Columbia University Medical Center; 🇺🇸 New York, New York, United States

Site 0213 - Center of Hope; 🇺🇸 Reno, Nevada, United States

Site 0146 - Maryland Oncology Hematology, PA; 🇺🇸 Rockville, Maryland, United States

Site 0277 - Alliance Cancer Specialist, PC; 🇺🇸 Wynnewood, Pennsylvania, United States

Site 0293 - Texas Oncology - Abilene; 🇺🇸 Abilene, Texas, United States

Site 0316 - Oncology Associates of Oregon, P.C.; 🇺🇸 Eugene, Oregon, United States

Site 0260 - Monument Health Rapid City Hospital; 🇺🇸 Rapid City, South Dakota, United States

Site 2715 - Icon Cancer Centre - Chermside; 🇦🇺 Brisbane, Queensland, Australia

Site 0149 - University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

Site 0132 - Avera Cancer Institute; 🇺🇸 Sioux Falls, South Dakota, United States

Site 0203 - Texas Oncology; 🇺🇸 Tyler, Texas, United States

Site 2707 - Mater Brisbane; 🇦🇺 South Brisbane, Queensland, Australia

Site 2717 - St John of God Hospital Subiaco; 🇦🇺 Subiaco, Western Australia, Australia

Site 3604 - Institut Gustave Roussy; 🇫🇷 Villejuif, France

Site 3616 - Centre Antoine Lacassagne; 🇫🇷 Nice, Alpes-Maritimes, France

Site 3602 - Centre Oscar Lambret; 🇫🇷 Lille, Nord, France

Site 3608 - Hospices Civils de Lyon - Hôpital Lyon Sud; 🇫🇷 Pierre-Bénite, Rhône, France

Site 3614 - Institut de Cancerologie de l'oust; 🇫🇷 Saint-Herblain, Pays De La Loire, France

Site 2405 - Centrum Badan Klinicznych JCI; 🇵🇱 Krakow, Malopolskie, Poland

Site 0226 - CoxHealth; 🇺🇸 Springfield, Missouri, United States

Site 2709 - Icon Cancer Research Adelaide; 🇦🇺 Adelaide, South Australia, Australia

Site 0181 - Sarasota Memorial Health Care System; 🇺🇸 Sarasota, Florida, United States

Site 0214-Ohio State University Comprehensive Cancer Center; 🇺🇸 Hilliard, Ohio, United States

Site 0170-USA Mitchell Cancer Institute; 🇺🇸 Mobile, Alabama, United States

Site 0284 - Community Health Network; 🇺🇸 Indianapolis, Indiana, United States

Site 0313 - Beacon Health System; 🇺🇸 South Bend, Indiana, United States

Site 2702 - Burnside War Memorial Hospital - The Brian Fricker Oncology Centre; 🇦🇺 Toorak Gardens, South Australia, Australia

Site 2701 - Sir Charles Gairdner Hospital; 🇦🇺 Nedlands, Western Australia, Australia

Site 0124 - University of California Irvine; 🇺🇸 Orange, California, United States

Site 0261 - Carle Cancer Institute; 🇺🇸 Urbana, Illinois, United States

Site 0221 - Tufts Medical Center - PPDS; 🇺🇸 Boston, Massachusetts, United States

Site 0220 - Westchester Medical Center; 🇺🇸 Hawthorne, New York, United States

Site 0283 - Miami Valley Hospital South; 🇺🇸 Centerville, Ohio, United States

Site 0262 - Lancaster General Hospital; 🇺🇸 Lancaster, Pennsylvania, United States

Site 0295 - Virginia Oncology Associates; 🇺🇸 Chesapeake, Virginia, United States

Site 0251 - Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States

Site 0317 - Nebraska Methodist Hospital; 🇺🇸 Omaha, Nebraska, United States

Site 0145- Texas Oncology - Austin; 🇺🇸 Austin, Texas, United States