cropped color_logo_with_background.png

A Study of CAN008 for Newly Diagnosed Glioblastoma Multiforme

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 20 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02853565
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

CANbridge Life Sciences Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ying Xu, MD
Principal Investigator Affiliation CANbridge Life Sciences Ltd.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries Taiwan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme
Additional Details

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: 1. To describe the toxicity associated with this regimen in adult patients with newly diagnosed glioblastoma multiforme. 2. To determine the duration of disease free survival and overall survival associated with this therapy.

Arms & Interventions

Arms

Experimental: CAN008

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

Interventions

Drug: - CAN008

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Chang Gung Memorial Hospital, Linkou, Taipei, Taiwan

Status

Address

Chang Gung Memorial Hospital, Linkou

Taipei, , 100

National Taiwan University Hospital, Taipei, Taiwan

Status

Address

National Taiwan University Hospital

Taipei, , 100