Status:
COMPLETED
A Trial of KB004 in Patients With Glioblastoma
Lead Sponsor:
Olivia Newton-John Cancer Research Institute
Collaborating Sponsors:
Humanigen, Inc.
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a study of drug KB004 in patients with recurrent glioblastoma (GBM). Eligible patients with measurable tumours will receive an initial trace (5mg) dose of zirconium labelled KB004 (89ZrKB004) ...
Eligibility Criteria
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
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03374943
Start Date
December 5 2017
End Date
September 22 2021
Last Update
November 4 2021
Active Locations (2)
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1
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
2
Austin Health
Heidelberg, Victoria, Australia, 3078