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Monoclonal Antibodies

ZN-c3 for Serous Carcinoma

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
Subjects must have platinum-resistant disease
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 60 months
Awards & highlights

Study Summary

This trial will test a new drug, ZN-c3, on people with cancer that has spread to other parts of the body. The drug will be given to see if it is effective and safe.

Who is the study for?
This trial is for adults over 18 with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who've had up to three prior treatments including bevacizumab. They must have a measurable lesion and an ECOG performance status of ≤1. Participants need to agree to contraception use during and after the trial for specified periods.Check my eligibility
What is being tested?
The study tests ZN-c3's effectiveness, safety, how it moves through the body (pharmacokinetics), and its impact on certain biomarkers in patients with specific types of advanced gynecological cancers that have worsened within six months despite treatment.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions related to drug ingredients or those common in cancer therapies such as fatigue, nausea, blood count changes. Specific side effects will depend on ZN-c3's action mechanism.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition did not improve with platinum-based chemotherapy.
Select...
I am 18 years old or older.
Select...
I have high-grade serous ovarian cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 60 months 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 of TEAEs
Incidence of dose modifications
Overall Response Rate defined by the revised RECIST v1 .1. and assessed by ICR.
+1 more
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.
Overall 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: Open-label with ZN-c3 (also known as azenosertib)Experimental 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
638 Total Patients Enrolled
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncLead Sponsor
7 Previous Clinical Trials
754 Total Patients Enrolled

Media Library

ZN-c3 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05128825 — Phase 2
Serous Carcinoma Research Study Groups: Open-label with ZN-c3 (also known as azenosertib)
Serous Carcinoma Clinical Trial 2023: ZN-c3 Highlights & Side Effects. Trial Name: NCT05128825 — Phase 2
ZN-c3 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05128825 — Phase 2

Frequently Asked Questions

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

Are patients being actively recruited for this experiment?

"This clinical trial is actively seeking candidates, as reported on clinicaltrials.gov. The study was initially posted on February 1st, 2021 and was last updated on August 18th, 2022."

Answered by AI

How many people are allowed to enroll in this research project?

"The sponsor, K-Group Beta, needs to recruit 105 eligible patients from various locations in order to begin the trial. For example, Site 0203 located in Tyler, Texas and Site 0277 situated in Wynnewood, Pennsylvania are both participating centres."

Answered by AI

Is this clinical test only being conducted in American hospitals?

"There are currently 22 locations where this study is enrolling patients, with Tyler, Wynnewood and Roanoke being a few examples. To limit the amount of travel required, please select the site that is closest to you."

Answered by AI

Is this medication able to be legally prescribed in the United States?

"This is a Phase 2 trial, which means that while there is some data supporting safety, there is no data yet to support efficacy. Our team at Power estimates the safety of this treatment to be a 2."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Site 0203 - Texas Oncology
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
A Study of ZN-c3 in Subjects With High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
2022. "A Study of ZN-c3 in Subjects With High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05128825.
All > Peritoneal Carcinomatosis
~28 spots leftby Apr 2025
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