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Monoclonal Antibodies

ZN-c3 for Uterine Cancer

Phase 2
Waitlist Available
Research Sponsored by K-Group Beta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females age ≥18 years of age at the time of informed consent
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Must not have
Prior therapy with ZN-c3 or any other WEE1 inhibitor
Prior treatment with a cell cycle checkpoint inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the effectiveness of a new drug, ZN-c3, in treating women with a certain type of cancer that has come back or does not respond to treatment.

Who is the study for?
This trial is for adult women with recurrent or persistent uterine serous carcinoma who are in good physical condition (ECOG PS of 0 or 1), have measurable disease, and proper organ function. Participants must be at least 18 years old and agree to use contraception. Women can't join if they've had certain prior treatments, other serious medical conditions, unresolved toxicities from past therapies, are pregnant/breastfeeding, have uncontrolled second cancers, or specific heart issues.
What is being tested?
The study tests the effectiveness and safety of a drug called ZN-c3 (azenosertib) specifically in women with uterine serous carcinoma that has come back or hasn't gone away after treatment. It's a Phase 2 clinical trial focusing on how well this drug works against this type of cancer.
What are the potential side effects?
While the side effects for ZN-c3 aren't detailed here, similar drugs often cause fatigue, nausea, blood count changes which could increase infection risk or bleeding tendencies; liver enzyme alterations indicating potential liver impact; hair loss; neuropathy; skin changes; and possible fertility effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 18 or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have at least one tumor that can be measured.
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My uterine cancer has come back or hasn't gone away.
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I am fully active or can carry out light work.
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I am a woman aged 18 or older.
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My uterine cancer has come back or never went away.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never been treated with ZN-c3 or any WEE1 inhibitor.
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I have been treated with a cell cycle checkpoint inhibitor before.
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I do not have another cancer that is spreading or needs treatment.
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I have a personal or family history of long QT syndrome.
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I don't have major side effects from previous treatments, except for mild nerve issues, hair loss, or skin color changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency and severity of TEAEs and incidence of dose modifications
Objective Response Rate as defined by the revised RECIST v1.1 as assessed by ICR
Secondary study objectives
Clinical Benefit Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Duration of Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Objective Response Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ZN-c3 Single AgentExperimental Treatment1 Intervention
ZN-c3 (azenosertib) taken orally with food

Find a Location

Who is running the clinical trial?

K-Group BetaLead Sponsor
5 Previous Clinical Trials
589 Total Patients Enrolled
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncLead Sponsor
7 Previous Clinical Trials
705 Total Patients Enrolled
Project DirectorStudy DirectorK-Group Beta (A wholly owned subsidiary of Zentalis Pharmaceuticals)

Media Library

ZN-c3 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04814108 — Phase 2
Uterine Carcinoma Research Study Groups: ZN-c3 Single Agent
Uterine Carcinoma Clinical Trial 2023: ZN-c3 Highlights & Side Effects. Trial Name: NCT04814108 — Phase 2
ZN-c3 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04814108 — Phase 2
~0 spots leftby Nov 2024
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