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

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ClinicalTrials.gov Identifier: NCT04814108
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
K-Group Beta

Brief Summary:
This is a Phase 2 study to evaluate the clinical activity, safety, pharmacokinetics (PK), and related biomarkers of ZN-c3 in adult women with recurrent or persistent uterine serous carcinoma (USC).

Condition or disease Intervention/treatment Phase
Uterine Serous Carcinoma Drug: ZN-c3 Phase 2

Detailed Description:
This is a Phase 2 open-label, multicenter study to evaluate the clinical activity, safety, pharmacokinetics (PK), and related biomarkers of ZN-c3 in adult women with recurrent or persistent uterine serous carcinoma (USC).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 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 Adult Women With Recurrent or Persistent Uterine Serous Carcinoma
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ZN-c3 Single Agent Drug: ZN-c3
ZN-c3 is an investigational drug.




Primary Outcome Measures :
  1. To investigate the antitumor activity of ZN-c3 based on the objective response rate (ORR). [ Time Frame: 2 years ]
    Objective response rate (ORR) as defined by the revised Response Evaluation Criteria in Solid Tumors RECIST Guideline version 1.1


Secondary Outcome Measures :
  1. To investigate the antitumor clinical activity based on Duration of Response (DOR) [ Time Frame: 2 years ]
    Duration of Response (DOR) as defined by the revised RECIST Guideline version 1.1

  2. To investigate the antitumor clinical activity based on Progression-Free Survival (PFS) [ Time Frame: 2 years ]
    Progression- free survival (PFS) as defined by the revised RECIST Guideline version 1.1

  3. To investigate the safety and tolerability of ZN-c3 [ Time Frame: 2 years ]
    Frequency and severity of AEs, including laboratory abnormalities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Females age ≥18 years of age at the time of informed consent.
  • Recurrent or persistent USC.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Measurable disease, defined as at least one lesion that can be accurately measured per revised Response Evaluation Criteria in Solid Tumors RECIST Guideline version 1.1 criteria.
  • Adequate hematologic and organ function.
  • Females of childbearing potential must agree to use an effective method of contraception per institutional standard prior to the first dose and for 90 days after the last dose of ZN c3.

Exclusion Criteria:

  • Prior treatment with a cell cycle checkpoint inhibitor.
  • Prior therapy with ZN-c3 or any other WEE1 inhibitor.
  • A serious illness or medical condition(s).
  • Unresolved toxicity of Grade > 1 attributed to any prior therapies (excluding ≤Grade 2 neuropathy, alopecia, or skin pigmentation).
  • Pregnant or lactating females (including the cessation of lactation) or females of childbearing potential who have a positive serum pregnancy test within 28 days prior to C1D1.
  • Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
  • 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of > 480 ms at screening, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
  • History or current evidence of congenital or family history of long QT syndrome.

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): NCT04814108


Contacts
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Contact: Project Director (858) 263-4333 info@zenopharma.com

Locations
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United States, Maryland
Site 0116 Recruiting
Baltimore, Maryland, United States, 21201
United States, Michigan
Site 0114 Recruiting
Farmington Hills, Michigan, United States, 48336
Site 0113 Recruiting
Sterling, Michigan, United States, 48659
United States, Oregon
Site 0117 Recruiting
Portland, Oregon, United States, 97213
United States, Virginia
Site 0130 Recruiting
Charlottesville, Virginia, United States, 22908
Australia, New South Wales
Site 2703 Recruiting
St Leonards, New South Wales, Australia, 2065
Australia, Victoria
Site 2706 Recruiting
Malvern, Victoria, Australia, 3144
Site 2704 Recruiting
Melbourne, Victoria, Australia, 3000
Canada, Quebec
Site 3401 Recruiting
Quebec City, Quebec, Canada, G1R 3S1
Georgia
Site 1406 Recruiting
Rustavi, Kvemo Kartli, Georgia
Site 1407 Recruiting
Batumi, Republic Of Adjara, Georgia, 6000
Sponsors and Collaborators
K-Group Beta
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Responsible Party: K-Group Beta
ClinicalTrials.gov Identifier: NCT04814108    
Other Study ID Numbers: ZN-c3-004
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Cystadenocarcinoma, Serous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Cystadenocarcinoma
Adenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous