Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
146 participants
INTERVENTIONAL
2019-11-01
2023-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
ZN-c3
ZN-c3 is a study drug
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.
ZN-c3
ZN-c3 is a study drug
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.
ZN-c3
ZN-c3 is a study drug
Interventions
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ZN-c3
ZN-c3 is a study drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Measurable or evaluable disease per RECIST version 1.1.
1. 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.
2. 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.
1. Measurable disease, defined as at least one lesion that can be accurately measured per RECIST version 1.1 criteria.
2. Recurrent or persistent USC or locally advanced or metastatic malignancy with one or more relevant biomarkers related to deoxyribonucleic acid (DNA) damage pathways.
Exclusion Criteria
2. Prior therapy with a WEE1 inhibitor.
3. A serious illness or medical condition(s).
4. Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia or skin pigmentation).
5. 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.
6. Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
7. 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.
8. History or current evidence of congenital or family history of long QT syndrome or Torsade de Pointes (TdP).
18 Years
ALL
No
Sponsors
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K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe Pultar, MD
Role: STUDY_DIRECTOR
K-Group Beta, a Zentalis Company
Locations
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Site 0102
Tucson, Arizona, United States
Site 0167
Newport Beach, California, United States
Site 0171
Chicago, Illinois, United States
Site 0101
Detroit, Michigan, United States
Site 0173
New York, New York, United States
Site 0179
Pittsburgh, Pennsylvania, United States
Site 0103
Houston, Texas, United States
Site 0100
San Antonio, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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ZN-c3-001
Identifier Type: -
Identifier Source: org_study_id
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