Clinical Trials List
Protocol NumberCAN-B1-008-L-002
NCT Number(ClinicalTrials.gov Identfier)NCT02853565
2016-07-01 - 2019-12-31
Phase I/II
Terminated3
ICD-10C71
Malignant neoplasm of brain
A Phase I/ II Study of CAN008 Plus Concomitant Temozolomide During and After Radiation Therapy in Patients with Newly Diagnosed Glioblastoma Multiforme
-
Trial Applicant
IQVIA RDS Taiwan Ltd.
-
Sponsor
CANbridge Life Sciences Ltd.
-
Trial scale
Taiwan Multiple Center
-
Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chi-Cheng Chuang Division of Orthopedics
- 蔡宏杰 Division of Orthopedics
- 黃盈誠 Division of Orthopedics
- Chi-Ting Liau Division of Hematology & Oncology
- Peng-Wei Hsu Division of Orthopedics
- Pin-Yuan Chen Division of Orthopedics
The Actual Total Number of Participants Enrolled
9 Stop recruiting
Audit
None
Co-Principal Investigator
- YA-FANG CHEN Division of Radiology
- 黃佩欣 Division of Others
- 陳婉瑜 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Glioblastoma Multiforme (GBM)
Objectives
Primary Objective
Phase I (Part A)
Safety and tolerability of CAN008 when administered in combination
with RT and TMZ
Phase II (Part B)
6-month Progression Free Survival (PFS6) rate
Secondary Objectives
Phase I (Part A)
RP2D
PK of CAN008
Preliminary efficacy (PFS6 and Progression Free Survival, PFS)
Exploring the biomarkers of CD95L, CpG2, and MGMT for their
predictive/prognostic value from retrospective analysis
Phase II (Part B)
Progression Free Survival (PFS)
Overall Survival (OS)
Cognitive function determined by Mini-Mental Status Examination
(MMSE)
Biomarkers in regard to their predictive/prognostic value (CD95L,
CpG2, MGMT, IDH1, 1P19q co-deletion)
Test Drug
CAN008(APG101)
Active Ingredient
recombinant glycosylated fusion protein
Dosage Form
IV injection
Dosage
200 mg in 10 ml (20 mg/ml)
Endpoints
PK Assessments:
A PK analysis will be done in patients in Phase I.
Safety Assessments
Safety laboratory (clinical chemistry, hematology, urinalysis)
Physical exam and vital signs
12-lead ECG (QT prolongation)
Tumor Assessments
MRI scans will be performed every 8 weeks after the end of RT or more
frequently if clinically indicated. RANO criteria (take pseudo-progression into
account) will be used for tumor assessment
A PK analysis will be done in patients in Phase I.
Safety Assessments
Safety laboratory (clinical chemistry, hematology, urinalysis)
Physical exam and vital signs
12-lead ECG (QT prolongation)
Tumor Assessments
MRI scans will be performed every 8 weeks after the end of RT or more
frequently if clinically indicated. RANO criteria (take pseudo-progression into
account) will be used for tumor assessment
Inclution Criteria
Main Inclusion criteria:
Subjects meeting all of the following criteria will be considered as eligible to be
enrolled into the study:
Newly diagnosed and histologically confirmed glioblastoma multiforme
Tumor must be surgically accessible and tissue must be available
Residual tumor after surgery less than 6c.c. (for Phase II)
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, noncytotoxic 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
Subjects meeting all of the following criteria will be considered as eligible to be
enrolled into the study:
Newly diagnosed and histologically confirmed glioblastoma multiforme
Tumor must be surgically accessible and tissue must be available
Residual tumor after surgery less than 6c.c. (for Phase II)
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, noncytotoxic 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
Main 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
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
The Estimated Number of Participants
-
Taiwan
55 participants
-
Global
0 participants
