Clinical Trials /

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

NCT04814108

Description:

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).

Related Conditions:
  • Endometrial Serous Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma
  • 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 IDs

  • ORG STUDY ID: ZN-c3-004
  • NCT ID: NCT04814108

Conditions

  • Uterine Serous Carcinoma

Interventions

DrugSynonymsArms
ZN-c3ZN-c3 Single Agent

Purpose

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).

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).
    

Trial Arms

NameTypeDescriptionInterventions
ZN-c3 Single AgentExperimental
  • ZN-c3

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:To investigate the antitumor activity of ZN-c3 based on the objective response rate (ORR).
Time Frame:2 years
Safety Issue:
Description:Objective response rate (ORR) as defined by the revised Response Evaluation Criteria in Solid Tumors RECIST Guideline version 1.1

Secondary Outcome Measures

Measure:To investigate the antitumor clinical activity based on Duration of Response (DOR)
Time Frame:2 years
Safety Issue:
Description:Duration of Response (DOR) as defined by the revised RECIST Guideline version 1.1
Measure:To investigate the antitumor clinical activity based on Progression-Free Survival (PFS)
Time Frame:2 years
Safety Issue:
Description:Progression- free survival (PFS) as defined by the revised RECIST Guideline version 1.1
Measure:To investigate the safety and tolerability of ZN-c3
Time Frame:2 years
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:K-Group Beta

Last Updated

August 24, 2021