Trial · NCT03374943
A Trial of KB004 in Patients With Glioblastoma
NCT03374943, Phase 1, Completed, Olivia Newton-John Cancer Research Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial of KB004 in Patients With Glioblastoma. Trials, record NCT03374943. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03374943
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of KB004 in Patients With Glioblastoma
- NCT number
- NCT03374943
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 12 participants, actual
- Lead sponsor
- Olivia Newton-John Cancer Research Institute
- Conditions
- Glioblastoma
- Interventions
- KB004
- First posted
- 2017-12-15
- Last updated
- 2021-11-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With KB004 Treatment-Related Adverse Events as Assessed using CTCAE v4.0. To determine the maximum tolerated dose (MTD). | 0-24 months | Three patients are recruited per dose level, 3 dose levels. Dose limiting toxicity (DLT) defined as Grade 4 neutropenia \> 7 day duration Grade 3 or 4 febrile neutropenia Grade 3 or 4 thrombocytopenia \> 7 day duration Grade 4 anaemia \> 7 day duration Grade 3 or 4 non-hematologic adverse events which do not resolve within 48 hours with maximal supportive care. Grade 4 or recurrent Grade 3 infusion reactions despite maximal supportive care and dose reductions Significant intracranial haemorrhage not reasonably attributed to other cause More than 14 days of treatment delay due to attributable toxicity Other toxicities as determined by the investigators. In the absence of any dose limiting toxicity in a cohort, escalate to the next dose level. If one DLT is seen in the first three patients of a cohort, an additional three patients will be recruited to that cohort. If two or more DLT's are seen in any cohort, that cohort will be deemed the maximum tolerated dose. |
| Secondary | Biodistribution of 89Zr-KB004 | 0-24 months | Eligible patients with measurable tumours will receive an initial trace (5mg) dose of zirconium labelled KB004 (89Zr-KB004) on day 1 followed by sequential Positron emission tomography, or PET imaging over 1 week to determine its biodistribution into GBM and normal tissues, frequency of EphA3 (ephrin type-A receptor 3) expression in glioblastoma (GBM) and quantitative tumor antibody uptake. |
| Secondary | Response rates following KB004 infusion | 0-24 months | Response Assessment in Neuro-Oncology criteria will be used to interpret MRI (magnetic resonance imaging) scans |
| Secondary | Plasma concentration versus time (Serum half life) of 89Zr-KB004 | 0-43 days | Pharmacokinetics (plasma concentration versus time) of 89Zr-KB004 will be determined using gamma well counting of the Zirconium in the samples at various timepoints-Day 1 89Zr-KB004 infusion: pre-infusion, 5min, 1 hour, 2 hours, 4 hours and 24 hours post infusion, then Day 3 or 4, 6 or 7. PK (Pharmacokinetics) timepoints Day 89Zr-KB004 infusion: pre-infusion, 5min, 1 hour, 2 hours, 4 hours and 24 hours post infusion then Day 39 or 40 and Day 42 or 43. |
| Secondary | Cmax of 89Zr-KB004 | 0-43 days | Pharmacokinetics (Cmax) of 89Zr-KB004 will be determined using gamma well counting of the Zirconium in the samples at various timepoints-Day 1 89Zr-KB004 infusion: pre-infusion, 5min, 1 hour, 2 hours, 4 hours and 24 hours post infusion, then Day 3 or 4, 6 or 7. PK (Pharmacokinetics) timepoints Day 89Zr-KB004 infusion: pre-infusion, 5min, 1 hour, 2 hours, 4 hours and 24 hours post infusion then Day 39 or 40 and Day 42 or 43. |
| Other | clinical outcomes via RANO criteria (Response Assessment in Neuro-Oncology Criteria) | 0-24 Months | describe response rates using Response Assessment in Neuro-Oncology Criteria to interpret MRI (magnetic resonance imaging) scans |
| Other | Biodistribution via PET (Positron-emission tomography) | 0-43 days | 89Zr-KB004 Positron emission tomography imaging will be used |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03374943
GET https://conductscience.org/api/trials/v1/NCT03374943/registered