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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05128825
Recruitment Status : Recruiting
First Posted : November 22, 2021
Last Update Posted : May 23, 2023
Sponsor:
Information provided by (Responsible Party):
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Study Description
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Brief Summary:
This is a Phase 2 open-label, multicenter study to evaluate the clinical activity, safety, pharmacokinetics (PK), and biomarker profile of ZN-c3 in subjects with Cyclin E driven High-Grade Serous Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer

Condition or disease Intervention/treatment Phase
Cyclin E Driven High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer Drug: ZN-c3 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 2 OPEN-LABEL, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF ZN-C3 IN SUBJECTS WITH HIGH-GRADE SEROUS OVARIAN, FAOLLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER (ZN-c3-005/GOG-3066/DENALI)
Actual Study Start Date : February 17, 2022
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : October 31, 2025
Arms and Interventions
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Intervention Details:
  • Drug: ZN-c3
    ZN-c3 is an investigational drug.

Outcome Measures
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Primary Outcome Measures :
  1. Part 1: To investigate the safety and tolerability of ZN-c3 [ Time Frame: Assessed from Cycle 1 Day 1 until 30 days after treatment discontinuation, up to 50 months (each cycle is 21 days) ]
    Frequency and severity of TEAEs according to the NCI-CTCAE Version 5.0

  2. Part 2: To investigate the antitumor activity of ZN-c3 based on the Objective Response Rate (ORR) [ Time Frame: Assessed every 6 weeks ]
    ORR is defined by RECIST v1.1


Secondary Outcome Measures :
  1. Part 1: 1) To investigate the antitumor activity of ZN-c3 [ Time Frame: Assessed every 6 weeks up to 50 months ]
    Objective Response Rate (ORR) as defined by RECIST v1.1

  2. Part 1: 2) To investigate the antitumor activity of ZN-c3 [ Time Frame: Assessed on treatment and then every 3 months up to 50 months ]
    Overall Survival (OS)

  3. Part 1: 3) To investigate the plasma PK of ZN-c3 [ Time Frame: Assessed on Cycle 1 Day 15 and all subsequent Day 1 up to Cycle 6 (each cycle is 21 days) ]
    The maximum plasma concentration (Cmax) of ZN-c3 (and its potential metabolites, as applicable) will be determined

  4. Part 1: 4) To investigate the plasma PK of ZN-c3 [ Time Frame: Assessed on Cycle 1 Day 15 and all subsequent Day 1 up to Cycle 6 (each cycle is 21 days) ]
    Area under the plasma concentration-time curve from 0 to 24h [AUC0-24h] of ZN-c3 (and its potential metabolites, as applicable) will be determined

  5. Part 1: 4) To investigate the plasma PK of ZN-c3 [ Time Frame: Assessed on Cycle 1 Day 15 and all subsequent Day 1 up to Cycle 6 (each cycle is 21 days) ]
    The Time to maximum plasma concentration (Tmax) of ZN-c3 (and its potential metabolites, as applicable) will be determined

  6. Part 2: 1) To further investigate the antitumor activity of ZN-c3 [ Time Frame: Assessed every 6 weeks up to 50 months ]
    Objective Response Rate (ORR) as defined by RECIST v1.1

  7. Part 2: 2) To further investigate the antitumor activity of ZN-c3 [ Time Frame: Assessed on treatment and then every 3 months up to 50 months ]
    Overall survival (OS)

  8. Part 2: 3) To investigate the safety and tolerability of ZN-c3 [ Time Frame: Assessed from Cycle 1 Day 1 until 30 days after treatment discontinuation, up to 50 months (each cycle is 21 days) ]
    Frequency and severity of TEAEs graded according to the NCI-CTCAE Version 5.0

  9. Part 2: 4) To investigate the plasma PK of ZN-c3 [ Time Frame: Assessed on Cycle 1 Day 15 and all subsequent Day 1 up to Cycle 6 (each cycle is 21 days) ]
    The maximum plasma concentration (Cmax) of ZN-c3 (and its potential metabolites, as applicable) will be determined

  10. Part 2: 5) To investigate the plasma PK of ZN-c3 [ Time Frame: Assessed on Cycle 1 Day 15 and all subsequent Day 1 up to Cycle 6 (each cycle is 21 days) ]
    Area under the plasma concentration-time curve from 0 to 24h [AUC0-24h] of ZN-c3 (and its potential metabolites, as applicable) will be determined

  11. Part 2: 5) To investigate the plasma PK of ZN-c3 [ Time Frame: Assessed on Cycle 1 Day 15 and all subsequent Day 1 up to Cycle 6 (each cycle is 21 days) ]
    The Time to maximum plasma concentration (Tmax) of ZN-c3 (and its potential metabolites, as applicable) will be determined


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years at the time of informed consent.
  2. Histologically or cytologically confirmed recurrent, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer with copy number amplification in the CCNE1 gene

  3. Prior therapy:

    1. Documented progressive disease ≤6 months
    2. One to 3 prior lines or regimens are allowed
    3. Prior bevacizumab treatment is required
  4. Subjects must have at least one measurable lesion as defined by RECIST Guideline Version 1.1.
  5. Performance Status: Eastern Cooperative Oncology Group (ECOG) score of ≤1.
  6. Adequate hematologic and organ function
  7. Females of childbearing potential and male subjects must agree to use an effective method of contraception prior to the first dose and for 6 months after the last dose of ZN-c3. Male subjects must agree to use an effective method of contraception prior to the first dose and for at least 3 months after the last dose of ZN-c3.
  8. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. 1. Any of the following treatment interventions within the specified time frame prior to C1D1:

    1. Major surgery within 28 days (any surgical incision should be fully healed prior to study drug administration);
    2. Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter);
    3. Radiation therapy within 21 days; however, if the radiation portal covered ≤5% of the bone marrow, the subject is eligible irrespective of the end date of radiotherapy.
    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).
    6. Inability to discontinue treatment prescription or non-prescription drugs, or to discontinue consumption of food and herbal supplements, that are strong/ and moderate CYP3A4 inhibitors and inducers, or P-gp inhibitors at least 14 days prior to C1D1.
  2. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, or CHK1/2 inhibitor.
  3. Known hypersensitivity to any inactive ingredients present in ZN-c3.
  4. A serious illness or medical condition(s)
  5. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia or skin pigmentation).
  6. Pregnant or lactating females or females of childbearing potential who has a positive serum pregnancy test within 14 days prior to C1D1.
  7. Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
  8. Individuals who are judged by the Investigator to be unsuitable as study subjects.
  9. 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >470 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
  10. History or current evidence of congenital or family history of long QT syndrome or Torsade de Pointes (TdP).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05128825


Contacts
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Contact: Project Director 858-263-4333 medicalaffairs@zentalis.com

Locations
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Sponsors and Collaborators
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
More Information
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Responsible Party: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT05128825    
Other Study ID Numbers: ZN-c3-005
First Posted: November 22, 2021    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Peritoneal Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases