Trial purpose
Cancer treatment
Tumor type
Brain and Spinal
Age
18+
Clinical summary
Summary
Participants in this trial will be entered at each KB004 dose level sequentially until 3-6 patients are evaluable for safety. Three sequential cohorts are planned: 3.5mg/kg, 5.25 mg/kg and 7.9 mg/kg
Conditions
This trial is treating people with glioblastoma
Eligibility
Inclusion
- 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)
Exclusion
- 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
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back (relapsed or recurrent).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Olivia Newton-John Cancer Research Institute
Scientific Title
A Phase I Safety and Bioimaging Trial of KB004 in Patients With Glioblastoma
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