A Study of CAN008 for Newly Diagnosed Glioblastoma Multiforme

NCT02853565 | Completed Phase 1 DMC

• 1 other identifier: CAN-B1-008-L-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (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.

  up to 2 years

Secondary Outcomes (6)

• Recommended Dose for Phase II [RP2D] measured by the Maximum Tolerated Dose [MTD] or the Maximum Administered Dose [MAD]

  up to 2 years

• PK profile measured by CAN008 serum concentrations

  up to 2 years

• PK profile measured by Maximum Plasma Concentration [Cmax]

  up to 2 years

• PK profile measured by Area Under the Curve [AUC]

  up to 2 years

• Preliminary efficacy (Progression Free Survival after 6 months [PFS6])

  up to 2 years

Study Arms (1)

CAN008

EXPERIMENTAL

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

Drug: CAN008

Interventions

CAN008 DRUG

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

CAN008

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CANbridge Life Sciences Ltd.: lead

Study Sites (2)

Chang Gung Memorial Hospital, Linkou

Taipei, 100, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 34911992 DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

APG101

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Ying Xu, MD

  CANbridge Life Sciences Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: August 3, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: November 8, 2018

Record last verified: 2017-09

Locations

TW (2)