Clinical trial · Interventional
A Study of CAN008 for Newly Diagnosed Glioblastoma Multiforme
A Phase I Study of CAN008 Plus Concomitant Temozolomide During and After Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme
NCT02853565CI-TRIAL-00035700completedPhase 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)
To evaluate CAN008 safety, tolerability, and pharmacokinetics (PK) of CAN008 when administered concurrent Plus Concomitant Temozolomide During and After Radiation Therapy in Patients with Newly Diagnosed Glioblastoma Multiforme.
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 Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAN008 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAN008
- description
- CAN008 administered as a 30 min intravenous infusion once a week until disease progression or unacceptable toxicity.
- interventionNames
- Drug: CAN008
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
- up to 2 years
- description
- The safety assessment will include safety laboratory (clinical chemistry, hematology, urinalysis), physical exam, vital signs and 12-lead ECG (QT prolongation). An AE can be any unfavourable and unintended sign, symptom, or disease temporarily associated with the use of a medicinal product, whether or not is considered to be related to the medicinal product. Pre-existing conditions worsen during a study are also to be reported as AEs. Furthermore, any side effects potentially related to the CAN008 treatment will be evaluated.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed and histologically confirmed glioblastoma multiforme * Tumor must be surgically accessible and tissue must be available * Age ≥ 20 years and \< 75 years * Life expectancy ≥ 6 months * Baseline MRI images must be done within 2 days after surgery * Patients must have a Karnofsky performances score ≥ 60 prior to treatment. * Patients must not have received prior cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy for brain tumors. * Adequate hematologic (absolute neutrophil count (ANC) ≥ 1.5x109/L, platelet count ≥ 100x109/L, hemoglobin ≥ 10 g/dL ), renal (creatinine ≤ 1.25xULN ), and hepatic function (total bilirubin ≤ 1.5xULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5xULN) * Women with childbearing potential must have a negative serum pregnancy test less than 7 days prior to the first dose of study drug. * Both men and women of reproductive potential agree to use approved contraception, such as condom and placement of an intrauterine device (IUD), during the study and until 3 months after the discontinuation of study treatment. * Willing and able to comply with the protocol as judged by the investigator * Patients must provide written consent Exclusion Criteria: * Any prior chemotherapy (including carmustine-containing wafers) or immunotherapy (including vaccine therapy ) * Any prior radiotherapy to the brain * Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial * Any contraindication to TMZ listed in the local label * Low-grade astrocytoma * Unable to undergo MRI * Past medical history of disease with poor prognosis according to the judgment of the Investigator * HIV infection * Patients with positive anti-HCV * Patients with positive HbsAG who received any related treatment within the past 6 months * Patients suffering from hereditary fructose intolerance (HFI). * Patients receive any investigational agent(s) or device(s) within 30 days prior to entering the study * Known coronary artery disease, significant arrhythmias or severe congestive heart failure
References
Publications (1)
- DERIVEDWei KC, Hsu PW, Tsai HC, Lin YJ, Chen KT, Toh CH, Huang HL, Jung SM, Tseng CK, Ke YX. Safety and tolerability of asunercept plus standard radiotherapy/temozolomide in Asian patients with newly-diagnosed glioblastoma: a phase I study. Sci Rep. 2021 Dec 15;11(1):24067. doi: 10.1038/s41598-021-02527-1. PMID 34911992