Clinical trial · Interventional
A Study of Intravenous EEDVsMit in Children With Recurrent / Refractory Solid or CNS Tumours Expressing EGFR
A Phase 1 Study of Intravenous EGFR-ErbituxEDVsMIT (EEDVsMit) in Children With Recurrent / Refractory Solid or CNS Tumours Expressing Epidermal Growth Factor Receptor (EGFR) (ECREST Study)
NCT02687386CI-TRIAL-00056521ECRESTterminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study medication no longer in production
Summary
Brief summary (as posted)
This is an open-label, sequential dose exploration study of single agent EEDVSMit administered by intravenous (IV) infusion twice weekly, followed by weekly maintenance dosing, in children with recurrent/refractory solid or CNS tumours.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CNS Tumours | Central Nervous System Neoplasm | ALIAS | 0.90 |
| Solid Tumours | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mitoxantrone packaged EDV (EnGeneIC Delivery Vehicle) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mitoxantrone packaged EDV
- description
- Mitoxantrone packaged EDV (EnGeneIC Dream Vector)
- interventionNames
- Drug: Mitoxantrone packaged EDV (EnGeneIC Delivery Vehicle)
Primary outcomes (3)
- measure
- MTD at which fewer than one third of patients experience dose limiting toxicity as assessed by CTCAE v4.0
- timeFrame
- Day 28 (cycle 1)
- description
- To determine a recommended phase 2 dose (RP2D) for EEDVsMit administered intravenously in children with recurrent / refractory solid or CNS tumours expressing EGFR
- measure
- Incidence of treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- Up to 35 days after the completion of study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be ≥ 2 years and ≤ 21 years old at the time of study enrolment. * Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age * Patients must have relapsed or refractory solid or CNS tumours or have a diagnosis of DIPG. Patients must have had histologic verification of malignancy at original diagnosis or relapse, or a diagnosis of DIPG by MRI imaging. * Patients must have either measurable or evaluable disease for Part B of the study only * Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life. * Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Exclusion Criteria: * Pregnant or breast-feeding women will not be entered on this study. * Any active uncontrolled infection * Patients who are known to be serologically positive for Hepatitis A, B or C, or have a history of liver disease, other forms of hepatitis or cirrhosis. * Known positive test for human immunodeficiency virus infection * Patients with disease of any major organ system that would compromise their ability to withstand therapy * Concurrent or prior (within 7 days of enrolment) anticoagulation therapy, except low molecular weight heparins or low dose aspirin * Patients receiving corticosteroids must be on a stable dose that has not been increased for at least 7 days prior to study enrolment. * Patients who are currently receiving another investigational drug are ineligible. * Patients who are currently receiving other antineoplastic agents are ineligible. * All herbal supplements, vitamins, and nutritional supplements taken within the last 30 days prior to dosing on Day 1 (and continued use, if appropriate), must be reviewed and approved by the Study Chair. * Patient will not be available for protocol-required study visits or procedures, to the best of the subject/parent/guardian's and investigator's knowledge. * Patient has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject/parent/guardian to give written informed consent and/or to comply with all required study procedures. * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. * Patients will be screened for antibodies to S. typhimurium and will not be eligible until antibodies are non-detectable * Patients will be screened for IL6 and TNFa cytokines and will not be eligible until levels are less than 3x times the detectable limit of the assay.
References
Publications (1)
- DERIVEDEvans L, Walker R, MacDiarmid J, Brahmbhatt H, Anazodo A, McCowage G, Gifford AJ, Kavallaris M, Trahair T, Ziegler DS. A Phase 1 Study of Intravenous EGFR-ErbituxEDVsMIT in Children with Solid or CNS Tumours Expressing Epidermal Growth Factor Receptor. Target Oncol. 2024 May;19(3):333-342. doi: 10.1007/s11523-024-01051-2. Epub 2024 Mar 28. PMID 38546944