Clinical trial · Interventional
Study of Zanzalintinib in Children and Adolescents With Relapsed or Refractory Solid Tumors
A Phase 1 Dose-Escalation Study of XL092 in Children and Adolescents With Relapsed or Refractory Solid Tumors
NCT07773454CI-TRIAL-00122665not yet recruitingPhase 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)
The primary purpose of this study is to determine the pediatric maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and to evaluate the safety and tolerability of zanzalintinib.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zanzalintinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zanzalintinib
- description
- Participants will receive zanzalintinib oral tablets once daily (QD).
- interventionNames
- Drug: Zanzalintinib
Primary outcomes (2)
- measure
- Number of Participants With Dose-Limiting Toxicities (DLTs)
- timeFrame
- Up to Day 28
- measure
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- timeFrame
- Up to 8 months
Secondary outcomes (3)
- measure
- Area Under the Concentration-Time Curve (AUC) of Zanzalintinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Months
- Maximum age
- 17 Years
Show eligibility criteria text
Key Inclusion Criteria: * Participants must be \< 17 years old. * Participants must have a minimum body weight of ≥ 10 kilograms (kg) at enrollment. * Performance status of ≥ 50% as measured by Lansky for participants \< 16 years of age or Karnofsky for participants ≥ 16 years of age. * Have a relapsed or refractory solid tumor, including primary CNS tumors (excluding lymphoma). Key Exclusion Criteria: * For participants with CNS primary tumors, evidence of intracranial or intratumoral hemorrhage are excluded. * Diagnosis of lymphoma. * Lesions invading major blood vessels including, but not limited to, inferior vena cava, pulmonary artery, or aorta. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.