76 Participants Needed

ZN-c3 for Uterine Cancer

Recruiting at 73 trial locations
PD
Overseen ByProject Director
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: K-Group Beta
Must be taking: Platinum-based, PD-(L)1 inhibitors, HER2-targeted
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have had chemotherapy, targeted tumor therapy, or investigational drug therapy within a certain time frame before starting the trial.

What makes the drug ZN-c3 unique for treating uterine cancer?

ZN-c3, also known as Azenosertib, is unique because it targets specific proteins involved in cancer cell growth and survival, potentially offering a new approach for treating uterine cancer compared to existing therapies.12345

Research Team

PD

Project Director

Principal Investigator

K-Group Beta (A wholly owned subsidiary of Zentalis Pharmaceuticals)

Eligibility Criteria

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.

Inclusion Criteria

I am a woman aged 18 or older.
I am fully active or restricted in physically strenuous activity but can do light work.
My blood counts and organ functions are within normal ranges.
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Exclusion Criteria

I have never been treated with ZN-c3 or any WEE1 inhibitor.
I have been treated with a cell cycle checkpoint inhibitor before.
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
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ZN-c3 (azenosertib) orally with food to evaluate clinical activity and safety

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

  • ZN-c3
Trial Overview 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ZN-c3 Single AgentExperimental Treatment1 Intervention
ZN-c3 (azenosertib) taken orally with food

Find a Clinic Near You

Who Is Running the Clinical Trial?

K-Group Beta

Lead Sponsor

Trials
6
Recruited
670+

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

Lead Sponsor

Trials
8
Recruited
740+

Findings from Research

ZKSCAN3 is significantly overexpressed in uterine cervical cancers compared to non-cancerous tissues, indicating its potential role as an oncoprotein in cancer development.
The overexpression of ZKSCAN3 is associated with poor overall survival in patients, suggesting it could serve as a valuable molecular marker for predicting prognosis and aiding in early detection of cervical cancer.
ZKSCAN3 Upregulation and Its Poor Clinical Outcome in Uterine Cervical Cancer.Lee, S., Cho, YE., Kim, JY., et al.[2019]
ZKSCAN3 is overexpressed in breast cancer tissues compared to normal tissues, and its high expression is associated with poor patient prognosis, indicating its potential as a biomarker for breast cancer severity.
Knocking down ZKSCAN3 in breast cancer cells significantly reduces cell viability, migration, and invasion, while also inhibiting the Akt/mTOR signaling pathway, suggesting that targeting ZKSCAN3 could be an effective therapeutic strategy for breast cancer.
ZKSCAN3 promotes breast cancer cell proliferation, migration and invasion.Chi, Y., Xu, H., Wang, F., et al.[2021]
SLC39A4 is significantly upregulated in cervical squamous cell carcinoma and endocervical adenocarcinoma, and higher levels of this gene are associated with shorter overall survival, indicating its potential as a prognostic marker.
The study found that SLC39A4 plays a crucial role in tumor cell metastasis and proliferation, and its high expression correlates with poor responses to chemotherapy and radiation, suggesting it could be a target for new treatment strategies.
The role of SLC39A4 in the prognosis, immune microenvironment, and contribution to malignant behavior in vivo and in vitro of cervical cancer.Zhao, YC., Wang, TJ., Cui, J., et al.[2023]

References

ZKSCAN3 Upregulation and Its Poor Clinical Outcome in Uterine Cervical Cancer. [2019]
ZKSCAN3 promotes breast cancer cell proliferation, migration and invasion. [2021]
The role of SLC39A4 in the prognosis, immune microenvironment, and contribution to malignant behavior in vivo and in vitro of cervical cancer. [2023]
The Role of ZNF275/AKT Pathway in Carcinogenesis and Cisplatin Chemosensitivity of Cervical Cancer Using Patient-Derived Xenograft Models. [2023]
ZC3H13 Enhances the Malignancy of Cervical Cancer by Regulating m6A Modification of CKAP2. [2023]