A Study of ZN-c3 in Participants With Solid Tumors
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ClinicalTrials.gov Identifier: NCT04158336 |
Recruitment Status :
Recruiting
First Posted : November 8, 2019
Last Update Posted : February 1, 2023
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Condition or disease | Intervention/treatment | Phase |
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Solid Tumor | Drug: ZN-c3 | Phase 1 |
This study will evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics of ZN-c3.
In Dose Escalation, the study will identify the Maximum Tolerated Dose (MTD) of ZN-c3 monotherapy in solid tumors.
The Food Effect cohort sub-study will examine ZN-c3 PK after a single dose and determine the bioavailability of ZN-c3 under fed and fasted conditions.
In Dose Expansion, single agent ZN-c3 will be evaluated at the RP2D in subjects with recurrent or persistent uterine serous carcinoma (USC) or subjects with locally advanced or metastatic solid tumor malignancies harboring biomarkers related to deoxyribonucleic acid (DNA) damage pathways.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 146 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | USC Cohort is Parallel Assignment and MOI Cohort is Single Group |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Study of ZN-c3 as a Single Agent in Subjects With Solid Tumors |
Actual Study Start Date : | November 1, 2019 |
Estimated Primary Completion Date : | May 2023 |
Estimated Study Completion Date : | August 2023 |
Arm | Intervention/treatment |
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Experimental: Single Agent Dose Escalation
Subjects with solid tumors with advanced or metastatic disease who are refractory or ineligible to standard therapy(ies) or for whom no standard therapy is available.
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Drug: ZN-c3
ZN-c3 is a study drug
Other Name: Study Drug |
Experimental: Single Agent Food Effect Cohort
Subjects with solid tumors with advanced or metastatic disease who are refractory or ineligible to standard therapy(ies) or for whom no standard therapy is available. This cohort will give subjects the option to continue treatment after PK assessments are completed.
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Drug: ZN-c3
ZN-c3 is a study drug
Other Name: Study Drug |
Experimental: Single Agent Dose Expansion
Subjects with histologically confirmed recurrent or persistent USC who have had treatment with at least 1 prior platinum-based chemotherapy regimen for management of advanced or metastatic USC and subjects with locally advanced or metastatic malignancy with one or more relevant biomarkers related to DNA damage pathways.
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Drug: ZN-c3
ZN-c3 is a study drug
Other Name: Study Drug |
- Dose Escalation [ Time Frame: Through completion, average of 1 year ]To investigate the safety and tolerability of single agent ZN-c3, including identification of the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), based on the incidence and severity of adverse events (AEs) and dose-limiting toxicities (DLTs) in DLT-evaluable subjects.
- Food Effect Cohort [ Time Frame: Through completion, approx 6 months ]To characterize and compare the PK (Cmax.) of ZN-c3 following a single dose of ZN-c3 under fed and fasting conditions.
- Food Effect Cohort [ Time Frame: Through completion, approximately 6 months ]To characterize and compare the PK (Tmax) of ZN-c3 following a single dose of ZN-c3 under fed and fasting conditions.
- Food Effect Cohort [ Time Frame: Through completion approximately 6 month ]To characterize and compare the PK (AUC0-last,AUC0-∞) of ZN-c3 following a single dose of ZN-c3 under fed and fasting conditions.
- Food Effect Cohort [ Time Frame: Through completion, approximately 6 mth ]To characterize and compare the PK (T1/2) of ZN-c3 following a single dose of ZN-c3 under fed and fasting conditions.
- Dose Expansion [ Time Frame: Through completion, approximately 43 month ]To investigate the clinical activity of WEE1 inhibition based on the objective response rate (ORR) as defined by the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Dose Escalation, Food Effect cohort & Dose Expansion [ Time Frame: Through completion ]To obtain preliminary estimates of antitumor efficacy of single agent ZN-c3 based on objective response rate (ORR) as defined by the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Food Effect Cohort [ Time Frame: Through completion ]To investigate electrocardiogram intervals (QTc Interval) via Holter monitoring after a single dose of ZN-c3 under fed and fasting conditions.
- Dose Escalation, Food Effect cohort and Dose Expansion [ Time Frame: Through completion. ]To obtain preliminary estimates of antitumor efficacy of single agent ZN-c3 based on Duration of Response (DOR) as defined by the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Dose Escalation, Food Effect cohort and Dose Expansion [ Time Frame: Through completion.. ]To obtain preliminary estimates of antitumor efficacy of single agent ZN-c3 based on Progression Free Survival (PFS) as defined by the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Dose Escalation, Food Effect cohort and Dose Expansion [ Time Frame: Through completion... ]To obtain preliminary estimates of antitumor efficacy of single agent ZN-c3 based on Clinical Benefit Rate (CBR) defined as complete response, partial response or stable disease according to the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Major Eligibility Criteria:
- Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Adequate hematologic and organ function.
- Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception and for 6 months and 90 days, respectively, after the last dose of ZN-c3.
Dose Escalation Inclusion Criteria:
- Subjects must have a solid tumor with advanced or metastatic disease, refractory to standard therapy or for whom no standard therapy is available, or the subject is ineligible for standard therapy(ies).
- Measurable or evaluable disease per RECIST version 1.1.
Food Effect Cohort Inclusion Criteria:
- Subjects with solid tumors with advanced or metastatic disease who are refractory or ineligible to standard therapy(ies) or for whom no standard therapy is available.
- Subjects must have no relevant dietary restrictions, and be willing to consume a high-calorie, high-fat breakfast and other standard meals provided during the study.
Dose Expansion Inclusion Criteria:
- Measurable disease, defined as at least one lesion that can be accurately measured per RECIST version 1.1 criteria.
- Recurrent or persistent USC or locally advanced or metastatic malignancy with one or more relevant biomarkers related to deoxyribonucleic acid (DNA) damage pathways.
Major Exclusion Criteria:
- Prior therapy with ZN-c3 or known hypersensitivity to any drugs similar to ZN-c3 in class or any inactive ingredients present in ZN-c3.
- Prior therapy with a 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 14 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, 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 or Torsade de Pointes (TdP).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158336
Contact: Project Director | 858-263-4333 | medicalaffairs@zentalis.com |
United States, Arizona | |
Site 0102 | Recruiting |
Tucson, Arizona, United States, 85719 | |
United States, California | |
Site 0167 | Recruiting |
Newport Beach, California, United States, 92663 | |
United States, Illinois | |
Site 0171 | Recruiting |
Chicago, Illinois, United States, 60637 | |
United States, Michigan | |
Site 0101 | Recruiting |
Detroit, Michigan, United States, 48201 | |
United States, New York | |
Site 0173 | Recruiting |
New York, New York, United States, 10029 | |
United States, Pennsylvania | |
Site 0179 | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
Site 0103 | Recruiting |
Houston, Texas, United States, 77030 | |
Site 0100 | Recruiting |
San Antonio, Texas, United States, 78229 |
Study Director: | Philippe Pultar, MD | K-Group Beta, a Zentalis Company |
Responsible Party: | K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT04158336 |
Other Study ID Numbers: |
ZN-c3-001 |
First Posted: | November 8, 2019 Key Record Dates |
Last Update Posted: | February 1, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Uterine Serous Carcinoma Solid Tumors Harboring Biomarkers Related to DNA Damage Pathways |
Neoplasms |