Clinical trial · Interventional
A Study of Azenosertib (ZN-c3) in Combination With Gemcitabine in Subjects With Osteosarcoma
A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination With Gemcitabine in Adult and Pediatric Subjects With Relapsed or Refractory Osteosarcoma
NCT04833582CI-TRIAL-00107259completedPhase 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 1/2 study of azenosertib (ZN-c3) in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma.
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 |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azenosertib | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Azenosertib in combination with Gemcitabine
- description
- Azenosertib (ZN-c3) in combination with Gemcitabine
- interventionNames
- Drug: Azenosertib
- Drug: Gemcitabine
Primary outcomes (2)
- measure
- Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events.
- timeFrame
- Through Cycle 1 (21 days) Phase 1
- measure
- Event-free survival (EFS) at 18 weeks per RECIST (Response Evaluation Criteria in Solid Tumors) Guideline version 1.1.
- timeFrame
- During phase 2, at 18 weeks
- description
- EFS at 18 weeks is defined as time from study enrollment until date of disease progression, or detection of disease at a previously uninvolved site, or date of death of the subjects at 18 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 12 years at the time of informed consent * Bodyweight ≥ 40 kg * Histologically documented relapsed or metastatic osteosarcoma. * Must have measurable disease according to RECIST Guideline version 1.1 criteria. * Adequate hematologic and organ function. * Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception per institutional standard prior to the first dose and for 6 months after study treatment discontinuation. * Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: * Unresolved toxicity of Grade \>1 attributed to prior therapies (excluding: Grade ≤2 neuropathy, alopecia, or skin pigmentation) * Prior therapy with a WEE1 inhibitor * A serious illness or medical condition(s). * Pregnant or lactating females. Females of childbearing potential with a positive serum pregnancy test \<14 days to Day 1. * Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy. * 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of \>470 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 Torsades de Pointes (TdP). * Taking medications with a known risk of TdP. * Administration of strong and moderate CYP3A4 inhibitors/inducers and strong and moderate P-gp inhibitors.
References
Publications (0)
Data not yet available
No reference posted for this study.