Clinical trial · Interventional
A Study of Azenosertib (ZN-c3) in Participants With Solid Tumors
A Phase 1 Study of ZN-c3 as a Single Agent in Subjects With Solid Tumors
NCT04158336CI-TRIAL-00105860completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 1 open-label, multicenter study of ZN-c3 (also known as Azenosertib) monotherapy which consists of Dose Escalation, a Food Effect Cohort, and Dose Expansion.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azenosertib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Single Agent Dose Escalation
- description
- 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.
- interventionNames
- Drug: Azenosertib
- type
- EXPERIMENTAL
- label
- Single Agent Food Effect Cohort
- description
- 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.
- interventionNames
- Drug: Azenosertib
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Major Eligibility Criteria: 1. Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of informed consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 3. Adequate hematologic and organ function. 4. 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: 1. 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). 2. Measurable or evaluable disease per RECIST version 1.1. Food Effect Cohort Inclusion Criteria: 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. Dose Expansion Inclusion Criteria: 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. Major Exclusion Criteria: 1. 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. 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).
References
Publications (0)
Data not yet available
No reference posted for this study.