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

Sponsor

K-Group Beta (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04814108

Collaborator

(none)

110

Enrollment

Locations

Arm

Anticipated Duration (Months)

5.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Uterine Serous Carcinoma	Drug: ZN-c3	Phase 2

Detailed Description

This is a Phase 2 open-label, multicenter study to evaluate the clinical activity, safety, pharmacokinetics (PK), and related biomarkers of ZN-c3 in adult women with recurrent or persistent uterine serous carcinoma (USC).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Adult Women With Recurrent or Persistent Uterine Serous Carcinoma

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ZN-c3 Single Agent	Drug: ZN-c3 ZN-c3 is an investigational drug.

Arm

Intervention/Treatment

Experimental: ZN-c3 Single Agent

Drug: ZN-c3

ZN-c3 is an investigational drug.

Outcome Measures

Primary Outcome Measures

To investigate the antitumor activity of ZN-c3 based on the objective response rate (ORR). [2 years]
Objective response rate (ORR) as defined by the revised Response Evaluation Criteria in Solid Tumors RECIST Guideline version 1.1

Secondary Outcome Measures

To investigate the antitumor clinical activity based on Duration of Response (DOR) [2 years]
Duration of Response (DOR) as defined by the revised RECIST Guideline version 1.1
To investigate the antitumor clinical activity based on Progression-Free Survival (PFS) [2 years]
Progression- free survival (PFS) as defined by the revised RECIST Guideline version 1.1
To investigate the safety and tolerability of ZN-c3 [2 years]
Frequency and severity of AEs, including laboratory abnormalities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Females age ≥18 years of age at the time of informed consent.
Recurrent or persistent USC.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Measurable disease, defined as at least one lesion that can be accurately measured per revised Response Evaluation Criteria in Solid Tumors RECIST Guideline version 1.1 criteria.
Adequate hematologic and organ function.
Females of childbearing potential must agree to use an effective method of contraception per institutional standard prior to the first dose and for 90 days after the last dose of ZN c3.

Exclusion Criteria:

Prior treatment with a cell cycle checkpoint inhibitor.
Prior therapy with ZN-c3 or any other WEE1 inhibitor.
A serious illness or medical condition(s).
Unresolved toxicity of Grade > 1 attributed to any prior therapies (excluding ≤Grade 2 neuropathy, alopecia, or skin pigmentation).
Pregnant or lactating females (including the cessation of lactation) or females of childbearing potential who have a positive serum pregnancy test within 28 days prior to C1D1.
Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
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.

History or current evidence of congenital or family history of long QT syndrome.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 0124	Orange	California	United States	92868
2	Site 0116	Baltimore	Maryland	United States	21201
3	Site 0114	Farmington Hills	Michigan	United States	48336
4	Site 0113	Sterling	Michigan	United States	48659
5	Site 0117	Portland	Oregon	United States	97213
6	Site 0130	Charlottesville	Virginia	United States	22908
7	Site 0112	Milwaukee	Wisconsin	United States	53226
8	Site 2705	Concord	New South Wales	Australia	2139
9	Site 2703	St Leonards	New South Wales	Australia	2065
10	Site 2702	Toorak Gardens	South Australia	Australia	6065
11	Site 2706	Malvern	Victoria	Australia	3144
12	Site 2704	Melbourne	Victoria	Australia	3000
13	Site 2701	Nedlands	Western Australia	Australia	6009
14	Site 3403	Toronto	Ontario	Canada	M4N 3M5
15	Site 3401	Quebec City	Quebec	Canada	G1R 3S1
16	Site 1406	Rustavi	Kvemo Kartli	Georgia	3700
17	Site 1407	Batumi	Republic Of Adjara	Georgia	6000
18	Site 1402	Tbilisi		Georgia	0112
19	Site 1403	Tbilisi		Georgia	0144
20	Site 1404	Tbilisi		Georgia	0160

Sponsors and Collaborators

K-Group Beta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

K-Group Beta

ClinicalTrials.gov Identifier:

NCT04814108

Other Study ID Numbers:

ZN-c3-004

First Posted:

Mar 24, 2021

Last Update Posted:

Feb 25, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Cystadenocarcinoma, Serous

Study Results

No Results Posted as of Feb 25, 2022