CompletedNCT02853565Updated Nov 8, 2018

A Study of CAN008 for Newly Diagnosed Glioblastoma Multiforme

A Phase 1 interventional study of CAN008 in Glioblastoma Multiforme, sponsored by CANbridge Life Sciences Ltd.. Completed at 2 sites in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-11-08.

Sponsored by CANbridge Life Sciences Ltd. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 10
Allocation: Not applicable
Ages: 20 Years to 75 Years
Sex: All

Study summary

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.

Read the detailed description

CAN008 is a glycosylated fusion protein consisting of the extracellular domain of human CD95 (APO-1/Fas) and the Fc domain of human IgG1. CAN008 blocks the interaction between CD95 and its cognate ligand CD95L. The target of CAN008 is the inhibition of CD95L. CD95L is expressed in glioblastoma whose cells are resistant to CD95-mediated apoptosis. CD95L was shown to be a crucial trigger in invasion and migration of tumor cells and neutralizing CD95L abolishes the invasive capacity of glioblastoma cells.

The purpose of the study is:

To describe the toxicity associated with this regimen in adult patients with newly diagnosed glioblastoma multiforme.
To determine the duration of disease free survival and overall survival associated with this therapy.

Conditions studied

Glioblastoma Multiforme

Browse trials for

Glioblastoma 1,916

Who can participate

Ages eligible: 20 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 10 participants (actual)

Study arms

Experimental
CAN008
CAN008 administered as a 30 min intravenous infusion once a week until disease progression or unacceptable toxicity.
Drug: CAN008

Interventions

DrugCAN008
The dose escalation in the phase I study including 200mg in the first cohort and 400mg in the second cohort to Recommended for Phase 2 Dose (RP2D)
Also known as: APG101

What researchers measure

Primary outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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.
Time frame: up to 2 years

Secondary outcomes

Recommended Dose for Phase II [RP2D] measured by the Maximum Tolerated Dose [MTD] or the Maximum Administered Dose [MAD]
The RP2D will be determined based on the assessment of the observed toxicities, the maximum tolerated dose (MTD) or the maximum administered dose (MAD), and the overall safety profile of CAN008.
Time frame: up to 2 years
PK profile measured by CAN008 serum concentrations
CAN008 serum concentrations will be determined.
Time frame: up to 2 years
PK profile measured by Maximum Plasma Concentration [Cmax]
Maximum Plasma Concentration \[Cmax\] will be determined.
Time frame: up to 2 years
PK profile measured by Area Under the Curve [AUC]
Area Under the Curve \[AUC\] will be determined.
Time frame: up to 2 years
Preliminary efficacy (Progression Free Survival after 6 months [PFS6])
PFS is defined as the time from date of randomization to the date of the event, which is the first radiologically documented disease progression (per local investigator assessment according to Response Assessment in Neuro-Oncology (RANO) criteria) or death due to any cause. For the primary analysis, progression-free survival after 6 months (PFS6) is defined as the crude rate of patients confirmed to be free of progression at 6 months after randomization with respect to the number of randomized and exposed patients in the respective treatment arm.
Time frame: up to 2 years
Preliminary efficacy (Overall Survival [OS])
Overall survival (OS) is defined as the time from the first dose of CAN008 to death.
Time frame: up to 2 years

Study locations

2 sites

Chang Gung Memorial Hospital, Linkou
Taipei, 100, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan

References and documents

Publications

Wei 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. PubMed 34911992 ↗

Individual participant data

Plan to share: Undecided

Registry details

Key details

Study ID: NCT02853565
Lead sponsor: CANbridge Life Sciences Ltd.
Responsible party: Sponsor
First posted: Aug 3, 2016
Start date: Aug 2016
Primary completion: Sep 2018
Completion: Sep 2018
Last update: Nov 8, 2018

Study contacts

Ying Xu, MD

study director · CANbridge Life Sciences Ltd.

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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