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Glioblastoma MultiformePhase 1NCT02853565

A Study of CAN008 for Newly Diagnosed Glioblastoma Multiforme

A Phase 1 study testing CAN008 in people with Glioblastoma Multiforme, run by CANbridge Life Sciences Ltd. at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Glioblastoma Multiforme
What is being tested?
CAN008
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesTaiwan
Study dates
Aug 2016to Sep 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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 locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Chang Gung Memorial Hospital, Linkou

    Taipei, 100

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

Official title: A Phase I Study of CAN008 Plus Concomitant Temozolomide During and After Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme

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:

  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.
Being tested
CAN008
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAN008Drug

    Also called APG101

    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)

Study groups in NCT02853565
Study groupRoleWhat they receive
CAN008ExperimentalCAN008 administered as a 30 min intravenous infusion once a week until disease progression or unacceptable toxicity.
Receives: Drug: CAN008

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 2 years

Secondary outcomes (6)

  1. 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.

    Measured: up to 2 years

  2. PK profile measured by CAN008 serum concentrations

    CAN008 serum concentrations will be determined.

    Measured: up to 2 years

  3. PK profile measured by Maximum Plasma Concentration [Cmax]

    Maximum Plasma Concentration [Cmax] will be determined.

    Measured: up to 2 years

  4. PK profile measured by Area Under the Curve [AUC]

    Area Under the Curve [AUC] will be determined.

    Measured: up to 2 years

  5. 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.

    Measured: up to 2 years

  6. Preliminary efficacy (Overall Survival [OS])

    Overall survival (OS) is defined as the time from the first dose of CAN008 to death.

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionSep 2018
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02853565
Sponsor's protocol ID
CAN-B1-008-L-002
Status last verified
Sep 2017
First submitted
11 Jul 2016
Last updated
8 Nov 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CAN008 in people with Glioblastoma Multiforme, run by CANbridge Life Sciences Ltd. at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02853565, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.

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