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

PHASE2RECRUITING

This is a Phase 2 study to evaluate the clinical activity and safety of ZN-c3 (azenosertib) in adult women with recurrent or persistent uterine serous carcinoma (USC).

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Study details:

This is a Phase 2 open-label, multicenter study to evaluate the clinical activity and safety of ZN-c3 (also known as azenosertib; KP-2638) in adult women with recurrent or persistent uterine serous carcinoma (USC).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Females ≥18 years of age at the time of informed consent.

Histologically confirmed recurrent or persistent USC for which no other proven effective treatment options are available or any available standard of care therapy was not tolerated or was refused by the subject.

Subjects with endometrial carcinoma of mixed histology where the serous component comprises at least 5% of the tumor will be considered eligible.

Subjects with carcinosarcomas (even if there is a serous component) are not eligible.

Measurable disease per RECIST Guideline Version 1.1

Required prior therapy for endometrial cancer:

Treatment with a platinum-based chemotherapy regimen.

Treatment with a PD-(L)1 inhibitor

Known HER2-positive tumors: Treatment with at least 1 HER2-targeted therapy, except for subjects who are not clinically eligible.

Adequate hematologic and organ function

Exclusion criteria

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

Major surgery within 28 days

Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter).

Radiation therapy within 21 days;

Autologous or allogeneic stem cell transplant within 3 months.

Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).

Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, or CHK1/2 inhibitor for USC.

A serious illness or medical condition(s) including, but not limited to: Any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1D1.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: Female

Things to know

Study dates

Study start: 2021-07-28

Primary completion: 2024-11-30

Study completion finish: 2025-05-31

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT04814108

Intervention or treatment

DRUG: ZN-c3

Conditions

• Uterine Serous Carcinoma

Image related to Uterine Serous Carcinoma

Condition: Uterine Serous Carcinoma
DRUG: ZN-c3
Concord, New South Wales, Australia and more
Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Concord Repatriation General Hospital

Research sites nearby

Select from list below to view details:

Concord Repatriation General Hospital
Concord, New South Wales, Australia
Cabrini Hospital Malvern
Malvern, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ZN-c3 Single Agent ZN-c3 (azenosertib) taken orally with food	DRUG: ZN-c3 ZN-c3 is an investigational drug.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Frequency and severity of TEAEs and incidence of dose modifications	To determine the safety and tolerability of ZN-c3 in subjects with recurrent or persistent USC.	2 years
Objective Response Rate as defined by the revised RECIST v1.1 as assessed by ICR	To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC	2 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Objective Response Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.	To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules	2 years
Duration of Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.	To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules	2 years
Progression Free Survival as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.	To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules	2 years
Clinical Benefit Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.	To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules	2 years
Time To Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.	To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules	2 years

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma