Clinical trial · Interventional
Phase 2 Study of CAN008 in Subjects With GBM
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of CAN008 Plus TMZ During and After Radiation Therapy in Subjects With Newly Diagnosed Glioblastoma
NCT05447195CI-TRIAL-00059612unknownPhase 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)
This is a multi-center, randomized, double-blind, placebo-controlled Phase 2 study whose objectives are to evaluate the clinical efficacy and safety of CAN008 plus TMZ during and after radiation therapy in newly-diagnosed subjects with glioblastoma who have undergone surgical excision.
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 |
|---|---|---|---|
| Newly-diagnosed Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAN008 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CAN008
- description
- CAN008 IV infusion weekly
- interventionNames
- Drug: CAN008
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- Placebo IV infusion weekly
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- Up to 3 years
- description
- To evaluate the efficacy of CAN008 plus temozolomide (TMZ) treatment in subjects with newly diagnosed glioblastoma (GBM) during and after radiation therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 to 70. * Newly diagnosed glioblastoma. * Tumor excision rate ≥80%. * Karnofsky performance score ≥70. Exclusion Criteria: * Medical history of brain radiation therapy or electric field treatment of tumor. * Primary infratentorial glioblastoma, multifocal glioma (≥ 2), or leptomeningeal metastasis. * Any malignant tumor (excluding WHO grade I-II low-grade astrocytomas, basal cell carcinoma, and carcinoma in situ). * Receiving high-dose hormone therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.