Clinical trial · Interventional
HMPL-813 in Treating Patients With Glioblastoma
A Phase Ib, Multi-center, Open-label Study of Epitinib Succinate (HMPL-813) in Treating Patients With Glioblastoma
NCT03231501CI-TRIAL-00045544unknownPhase 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 an open-label study, to evaluated epitinib, which is a selective epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), to treat glioblastoma patients with EGFR gene amplification. As epitinib could cross blood-brain barrier (BBB), inhibition of EGFR may provide a novel mechanism in treating glioblastoma.
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 |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epitinib succinate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm
- description
- This is a single arm study. It is an open-label study. The intervention is eptinib succinate.
- interventionNames
- Drug: epitinib succinate
Primary outcomes (1)
- measure
- objective response rate (ORR)
- timeFrame
- 6 months
- description
- the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed glioblastoma 2. Standard treatment failed or no standard treatment 3. EGFR gene amplification 4. Clearly measurable lesions (according to Response Assessment in Neuro-Oncolog (RANO)) 5. Age ≥ 18 6. Eastern Cooperative Oncology Group (ECOG) score ≤2 Exclusion Criteria: 1. Use of Antiepileptic drugs were used\] within 2 weeks before enrollment 2. Immunotherapy, anti-angiogenesis or EGFR TKI and its downstream pathway signaling molecules and other targeted drugs within 4 weeks before enrollment; temozolomide chemotherapy, cranial radiotherapy or other systemic anti-tumor therapy within 3 weeks before enrollment 3. Previous toxic effects of anticancer therapy have not yet been recovered (defined as not restored to 0 or 1 level, except alopecia) or have not been fully recovered from previous surgery 4. Uncontrolled active infections such as acute pneumonia, Hepatitis B Virus (HBV) and so on 5. Eye disease or dry eye syndrome history 6. Positive pregnancy tested result
References
Publications (0)
Data not yet available
No reference posted for this study.