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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03374943




Registration number
NCT03374943
Ethics application status
Date submitted
26/09/2017
Date registered
15/12/2017

Titles & IDs
Public title
A Trial of KB004 in Patients With Glioblastoma
Scientific title
A Phase I Safety and Bioimaging Trial of KB004 in Patients With Glioblastoma
Secondary ID [1] 0 0
ONJ2017-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KB004

Experimental: KB004 dose escalation - Patients will be entered at each KB004 dose level sequentially until 3-6 patients are evaluable for safety. Three sequential cohorts are planned in this study (3.5mg/kg, 5.25 mg/kg, 7.9 mg/kg) Additional dose levels may be explored based on the emerging data in the study.


Treatment: Drugs: KB004
KB004 is a recombinant, non-fucosylated, IgG1? (human f-allotype) monoclonal antibody targeting the extracellular ligand binding domain of the EphA3 (ephrin receptor) tyrosine kinase
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With KB004 Treatment-Related Adverse Events as Assessed using CTCAE v4.0. To determine the maximum tolerated dose (MTD).
Timepoint [1] 0 0
0-24 months
Secondary outcome [1] 0 0
Biodistribution of 89Zr-KB004
Timepoint [1] 0 0
0-24 months
Secondary outcome [2] 0 0
Response rates following KB004 infusion
Timepoint [2] 0 0
0-24 months
Secondary outcome [3] 0 0
Plasma concentration versus time (Serum half life) of 89Zr-KB004
Timepoint [3] 0 0
0-43 days
Secondary outcome [4] 0 0
Cmax of 89Zr-KB004
Timepoint [4] 0 0
0-43 days

Eligibility
Key inclusion criteria
* Adults (greater than or equal to 18 years of age) with histologically proven glioblastoma
* Evidence of progressive glioblastoma (if within 3 months of radiotherapy, then progression outside of radiotherapy field is required)
* Measurable disease by RANO (Response Assessment in Neuro-Oncology Criteria)
* ECOG (Eastern Cooperative Oncology Group score) 0 to 1
* Expected survival more than 3 months
* Steroid dose less than 2.5 mg per day dexamethasone equivalents and stable or reducing for 1 week prior to day 1
* Archived (formalin fixed paraffin embedded) tissue or frozen tumour tissue or consent to obtain a fresh tumour biopsy at enrolment is required.
* Adequate organ function. Out of range values that are not clinically significant will be permitted, except for the following laboratory parameters which must be within the ranges specified
* Neutrophils greater than or equal to 1.5 x 109 per L
* Platelets greater than or equal to 100 x 109 per L
* International Normalised Ratio less than or equal to 1.4
* Serum Aspartate aminotransferase and Alanine aminotransferase less than or equal to 2.5 x ULN (upper limit of normal)
* Serum bilirubin less than or equal to 1.5 x ULN (upper limit of normal)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Evidence of infratentorial, extracranial or leptomeningeal disease
* More than one prior systemic therapy for progressive disease or prior Steriotactic radiosurgery (SRS) to sites of GB (glioblastoma).
* Prior treatment with bevacizumab or gliadel wafers
* Evidence of current or prior intracranial hemorrhage
* Need for anti-platelet or anti-coagulant drugs
* Use of anti-cancer therapy including craniotomy, chemotherapy, immunotherapy, radiotherapy, or any investigational therapy within 28 days prior to Study Day 1
* History of major immunologic reaction to any immunoglobulin G containing agent
* Medical conditions which place the subject at an unacceptably high risk
* Subject is pregnant, lactating or unwilling or unable to use adequate contraception

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/09/2021
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [2] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
3078 - Heidelberg

Funding & Sponsors
Primary sponsor type
Other
Name
Olivia Newton-John Cancer Research Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Humanigen, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hui Gan
Address 0 0
Austin Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03374943