Clinical trial · Interventional
The Efficacy of HLX208 (BRAF V600E Inhibitor) for Refractory Primary Brain Tumors With BRAF Mutation After First-line Treatment
An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Refractory Primary Brain Tumors With BRAF Mutation
NCT05092802CI-TRIAL-00058223unknownPhase 2ClinicalTrials.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)
An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for refractory primary brain tumors with BRAF mutation
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 |
|---|---|---|---|
| Brain Tumor, Primary | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HLX208 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HLX208
- interventionNames
- Drug: HLX208
Primary outcomes (1)
- measure
- ORR
- timeFrame
- from first dose to the last patient was followed up for 6 month
- description
- Objective response rate(assessed by independent radiological review committee (IRRC) based on the RANO
Secondary outcomes (3)
- measure
- PFS
- timeFrame
- from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，an average of about 1 year
- description
- Progression-free survival(PFS):assessed by IRRC and the investigator based on the RANO
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age\>=18Y * Good Organ Function * Expected survival time ≥ 3 months * Refractory primary brain tumors with BRAF mutation that have been diagnosed * Unable to receive surgery/radiotherapy, or have treatment failed after surgery/radiotherapy * ECOG score 0-1; Exclusion Criteria: * Previous treatment with BRAF inhibitors or MEK inhibitors * A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery * Severe active infections requiring systemic anti-infective therapy * Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
References
Publications (0)
Data not yet available
No reference posted for this study.