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Monoclonal Antibodies

ZN-c3 for Uterine Cancer

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: ZN-c3 Single AgentExperimental Treatment1 Intervention

ZN-c3 (azenosertib) taken orally with food

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

K-Group BetaLead Sponsor

5 Previous Clinical Trials

598 Total Patients Enrolled

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncLead Sponsor

7 Previous Clinical Trials

714 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any substantial sites in North America hosting this clinical experiment?

"In addition to the 11 sites in total, Site 0112 located in Milwaukee Wisconsin, Site 0124 situated in Orange California and Site 3403 found in Toronto Ontario are participating."

Answered by AI

Are there still opportunities for involvement in this research program?

"Clinicialtrials.gov shows that this research endeavour is presently seeking participants, having first been posted on June 1st 2021 and last revised on February 24th 2022."

Answered by AI

What is the current number of participants in this experiment?

"This trial requires 110 participants that abide by the pre-set inclusion criteria. Participants may join this clinical experiment from various sites such as Site 0112 in Milwaukee, Wisconsin and Site 0124 in Orange, California."

Answered by AI

Has ZN-c3 been granted market authorization by the FDA?

"Our team at Power gave ZN-c3 a safety score of 2, as this is an experimental Phase 2 trial with preliminary data indicating its security but no studies demonstrating effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04814108.

All > Uterine Cancer