GlioblastomaPhase 1CerebralEDVNCT02766699
A Study to Evaluate the Safety, Tolerability and Immunogenicity of EGFR(V)-EDV-Dox in Subjects With Recurrent GBM
A Phase 1 study testing EGFR(V)-EDV-Dox in people with Glioblastoma and Astrocytoma, Grade IV, run by Engeneic Pty Limited at 2 sites in United States.
Trial summary
The purpose of the Cerebral EDV study is to determine the safety and tolerability of EGFR(V)-EDV-Dox in order to establish the best dose level to be used in future studies. The study will also examine the body's immune response to EGFR(V)-EDV-Dox and assess if it is effective in the treatment of patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Astrocytoma, Grade IV
- What is being tested?
- EGFR(V)-EDV-Dox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Oct 2016to 30 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Karnofsky Performance Status (KPS) ≥ 60%.
- Life expectancy ≥ 3 months.
- Pathologically documented, and definitively diagnosed recurrent World Health Organization (WHO) Grade IV astrocytoma (GBM).
- Participant must have archived tumor tissue available from initial diagnosis or subsequent relapse(s) of Grade IV GBM for submission for central review at Investigational sites local laboratories.
- Recurrence or progression of disease (confirmed by MRI and measurable by RANO criteria) following receipt of standard of care therapy, which includes maximum safe surgical resection, standard adjuvant radiation/temozolomide treatment. Participants must have completed at least 21 days of temozolomide treatment in combination with radiation therapy to be considered to have received standard of care therapy.
- Participant has received no more than 1 other therapeutic regimen other than those listed above in (5).
Show all 32Show fewer
- Participant may be receiving steroid therapy at time of enrollment (stable dose of ≤ 4 mg/day of dexamethasone or steroid equivalent).
- Ability to undergo MRI evaluation.
- Participant has ≥ 1 site of bi-dimensionally measurable disease measured using contrast enhanced MRI.
- Hematological function:
- White blood cell count (WBC) ≥ 3.0 x 109/L
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin > 9 g/dL
- Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)
- International normalized ratio (INR) < 1.5 x ULN
- Renal function:
- Blood urea nitrogen (BUN) < 30 mg/dL
- Creatinine serum levels ≤ 1.5 x ULN
- Or creatinine clearance ≥ 60 mL/minute for subjects with serum creatinine outside the normal range (calculated using the Cockcroft-Gault equation).
- Hepatic function:
- Aspartate aminotransferase (AST) < 2.5 x ULN (3 x ULN for subjects on chronic anticonvulsive therapies known to increase transaminases).
- Alanine aminotransferase (ALT) < 2.5 x ULN (3 x ULN for subjects on chronic anticonvulsive therapies known to increase transaminases).
- Alkaline phosphatase (ALP) < 2.5 x ULN (3 x ULN for subjects on chronic anticonvulsive therapies).
- Total bilirubin ≤ 1 x ULN (unless elevated due to Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction. Subjects with ≥1 x ULN will be tested for direct bilirubin fraction so that the indirect fraction can be calculated).
- Adequate cardiac function with left ventricular ejection fraction (LVEF) ≥ 55% at baseline.
- Serum phosphate levels that are within normal limits (2.4 - 4.1 milligrams per deciliter mg/dL) at baseline.
- Subject meets the reproductive criteria as follows:
- Female subjects who are of non-reproductive potential (ie, post menopausal by history - no menses for ≥ 1 year and follicle-stimulating hormone (FSH) level consistent with post-menopausal status; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the 1st dose, if more than 7 days prior, a urine pregnancy test must be performed before the 1st dose. The female subject must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study IP administration. Highly effective methods of birth control include sexual abstinence, hormonal birth control, or intrauterine device (women), vasectomy or a condom with spermicide (men) in combination with barrier methods.
- Male subjects who are willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last IP administration.
- All study subjects must be willing to ensure that corresponding sexual partners practice these same methods of highly effective birth control for the same duration.
Who cannot join
- History of central nervous system bleeding as defined by stroke or intraocular bleed within 6 months of enrollment.
- Evidence of acute intracranial / intra-tumoral hemorrhage, except for participants with stable grade 1 hemorrhage.
- History of coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association > Class II), uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100 mmHg) or cardiac arrhythmias requiring anti-arrrhythmic therapy.
- Clinically significant electrocardiogram (ECG) changes at enrollment which obscure the ability to assess the PR, QT, and QRS interval; congenital long QT syndrome.
- Active infection requiring treatment.
- History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other malignancies curatively treated with no evidence of disease for ≥ 2 years.
Show all 19Show fewer
- Known positive test for human immunodeficiency virus infection (HIV), or active hepatitis B or hepatitis C infection.
- Receipt of therapies or procedures prior to first dose including:
- Radiation therapy within 6 months of Study Day 1 or has not recovered from the toxic effects of such therapy.
- Bevacizumab® or other anti-angiogenic therapy.
- Gliadel® Wafer (within 6 months of Study Day 1, or has not recovered from the toxic effects of such therapy).
- Immunotherapeutic agents, vaccines, or monoclonal antibody therapy (within 4 weeks of Study Day 1 or has not recovered from the toxic effects of such cancer therapy).
- Temozolomide or other chemotherapy (within 4 weeks of Study Day 1 or 6 weeks for nitrogen mustards, or has not recovered from the toxic effects of such cancer therapy).
- Anticoagulation therapy (within 7 days of Study Day 1), except low molecular weight heparins or low dose aspirin.
- Other investigational therapy (within 30 days of Study Day 1).
- Surgical resection of brain tumor (within 4 weeks of Study Day 1 or has not recovered from acute side effects of such therapy except for neurological effects).
- Any major surgery (within 4 weeks of Study Day 1, or has not recovered from the effects of such surgery).
- Subject has a known allergic/hypersensitivity to investigational components or excipients (doxorubicin, trehalose, monoclonal antibody therapy, penicillin class of antibiotics, gentamicin (or other aminoglycosides), or ciprofloxacin hydrochloride (or other quinolones)).
- If female, is pregnant or is breast feeding.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John Hopkins Hospital
Baltimore, Maryland, 21287
Lenox Hill Hospital, Northwell Health
New York, New York, 10075
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of EGFR (Vectibix® Sequence)-Targeted EnGeneIC Dream Vectors Containing Doxorubicin (EGFR(V)-EDV-Dox) in Subjects With Recurrent Glioblastoma Multiforme (GBM)
The purpose of the Cerebral EDV study is to determine the safety and tolerability of EGFR(V)-EDV-Dox in order to establish the best dose level to be used in future studies. The study will also examine the body's immune response to EGFR(V)-EDV-Dox and assess if it is effective in the treatment of patients with recurrent glioblastoma multiforme (GBM).
Read the detailed description
This is an open-label, Phase 1, dose exploration and preliminary immunogenicity study of single agent EGFR(V)-EDV-Dox in subjects with recurrent glioblastoma (GBM). Eligible subjects enrolled in the study will receive EGFR(V)-EDV-Dox administered weekly for 7 weeks via IV 20 minute infusion, followed by radiological evaluation at week 8 (1 Cycle). Subjects may continue to receive subsequent cycles of EGFR(V)-EDV-Dox unless the subject becomes intolerant to investigational product (IP), withdraw consent or the individual is no longer receiving clinical benefit (factors taken in to consideration will be disease progression radiologically or clinically, and clinical benefits to quality of life). Tumour assessment will be repeated after each 7 week cycle (week 8).
The study will take place in two parts, Part 1 (Dose Exploration) and Part 2 (Dose Expansion).
Part 1 - Dose Exploration will assess the safety and tolerability of multiple doses of drug at two dose levels (5 x 10^9 and 8 x 10^9) and will enroll prior to Part 2. Three subjects will be recruited per dose level. Enrollment will begin with the 5 x 10^9 dose level, and the decision to enroll to the 8 x 10^9 dose level will follow a comprehensive safety evaluation and a standard 3 + 3 dose escalation study design.
Part 2 - Dose Expansion will be conducted pending safety results of Part 1 to provide guidance regarding the recommended phase 2 dose (RP2D). Subjects will be treated and assessed as outlined in Part 1 above. If 0 out of 3 subjects, or 1 out of 6 subjects, experience dose limiting toxicities (DLTs) at the 5 x 10^9 dose level in Part 1, additional subjects to a total of 10 will be recruited to this dose level in Part 2. Similarly, if 0 out of 3 subjects, or 1 out of 6 subjects, experience DLTs at the 8 x 10^9 dose level in Part 1, additional subjects to a total of 10 will be recruited to this dose level in Part 2. If both dose levels are tolerated, a total of 10 subjects per dose level will be enrolled.
A safety follow-up visit must be performed 30 (+5) days after the last dose of drug for all subjects.All subjects who discontinue investigational product and who have not withdrawn full consent to participate in the study will continue in the long term follow-up phase. Long term follow-up will continue approximately every 1 month for 12 months, from the 30 (+5) day follow-up visit, then approximately every 2-3 months for the extent of subject survival.
- Conditions
- Glioblastoma, Astrocytoma, Grade IV
- Being tested
- EGFR(V)-EDV-Dox
- Keywords
- Astrocytoma, Grade IV, Doxorubicin, Glioblastoma, Neoplasms, Neoplasms by Site, Antineoplastic Agents, Drug Delivery Systems, Molecular Targeted Therapy, Nanoparticles, Disease Progression, Recurrence, Brain Neoplasms, Immunotherapy, Receptor, Epidermal Growth Factor, Antibodies, Bispecific
- Medical subject headings
- Glioblastoma, Neoplasms, Neoplasms by Site, Disease Progression, Recurrence, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR(V)-EDV-DoxDrug
Also called EnGeneIC Dream Vector™, EnGeneIC Delivery Vehicle™
EGFR(V)-EDV-Dox using EnGeneIC EDV™ technology is a bacterially derived minicell which packages a toxic payload, Doxorubicin, into a 400 nm particle which targets specific cancer cells using bispecific antibodies (BsAb). BsAb-targeted, payload-packaged EDV nanocells only exit the leaky blood vessels associated with tumors and enter into the tumor microenvironment. The BsAb binds to the tumor cell-surface receptor, where the EDV is taken up, broken down within the cancer cell and releases the Doxorubicin. The residual EDVs that do not make it into the tumor microenvironment, are engulfed by cells of the immune system and since the EDVs are derived from bacteria, they carry potent immuno-stimulating components which appear to bypass the immuno-suppression caused by the tumor.
| Study group | Role | What they receive |
|---|---|---|
| EGFR(V)-EDV-Dox | Experimental | EGFR(V)-EDV-Dox administered via 20 minute intravenous infusion once a week for seven weeks (1 Cycle). Subjects will receive one of two dose levels: 5 x 10^9 or 8 x 10^9. All subjects will undergo an adapted dose escalation regime in the first cycle of treatment. For subsequent cycles all doses will be administered at full strength (5x10^9 or 8x10^9 EGFR(V)-EDV-Dox). Subjects may receive further cycles of treatment if the tumor remains stable or is responding, and/or they are deriving clinical benefit from the therapy and are tolerating treatment. Receives: Drug: EGFR(V)-EDV-Dox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcome measures
Recording of adverse Events (AE's) and clinically significant changes in vital signs, physical and neurological examinations, cardiac tests, radiological imaging inc. CT scan (Day 27/28) and clinical laboratory tests.
Measured: Safety measures will be conducted from Study Day 1 as per study schedule to safety follow-up visit 30 (+5 days) post last dose.
Secondary outcomes (3)
Efficacy outcome measure
Disease response will be measured by Magnetic Resonance Imaging (MRI) using Response Assessment in Neuro-Oncology (RANO).
Measured: Screening, then post cycle (Days 50-56)
Identification of a recommended Phase 2 dose (RP2D) of EGFR(V)-EDV-Dox in subjects with recurrent GBM
Review of safety data for dose limiting toxicity (DLT) evaluable subjects.
Measured: DLT evaluable subjects are those who experience a DLT assessed within the first treatment cycle of Part 1 i.e.including up to 7 days after the final dose, days 1-50 of treatment.
Overall survival outcome measure
Overall survival is defined as time from the date of first administration of EGFR(V)-EDV-Dox to the date of death, regardless of cause
Measured: The number of days from the date of first administration of EGFR(V)-EDV-Dox to the date of death, regardless of cause up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study start25 Oct 2016
- Primary completion21 Aug 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3+3 dose escalation study
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Engeneic Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Jennifer MacDiarmid, Ph.D, Study director, Engeneic Pty LimitedHimanshu Brahmbhatt, Ph. D, Study director, Engeneic Pty LimitedGary L Gallia, M.D., Ph.D, Principal investigator, Johns Hopkins UniversityStuart A Grossman, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766699
- Sponsor's protocol ID
- ENG7
- Acronym
- CerebralEDV
- Status last verified
- May 2025
- First submitted
- 3 May 2016
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of EGFR (Vectibix® Sequence)-Targeted EnGeneIC Dream Vectors Containing Doxorubicin (EGFR(V)-EDV-Dox) in Subjects With Recurrent Glioblastoma Multiforme (GBM)
- ClinicalTrials.gov ID
- NCT02766699
- Acronym / sponsor ID
- CerebralEDV / ENG7
- Conditions
- Glioblastoma, Astrocytoma, Grade IV
- Keywords
- Astrocytoma, Grade IV, Doxorubicin, Glioblastoma, Neoplasms, Neoplasms by Site, Antineoplastic Agents, Drug Delivery Systems, Molecular Targeted Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Engeneic Pty LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 21 Aug 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 10 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the Cerebral EDV study is to determine the safety and tolerability of EGFR(V)-EDV-Dox in order to establish the best dose level to be used in future studies. The study will also examine the body's immune response to EGFR(V)-EDV-Dox and assess if it is effective in the treatment of patients with recurrent glioblastoma multiforme (GBM).
Detailed description
This is an open-label, Phase 1, dose exploration and preliminary immunogenicity study of single agent EGFR(V)-EDV-Dox in subjects with recurrent glioblastoma (GBM). Eligible subjects enrolled in the study will receive EGFR(V)-EDV-Dox administered weekly for 7 weeks via IV 20 minute infusion, followed by radiological evaluation at week 8 (1 Cycle). Subjects may continue to receive subsequent cycles of EGFR(V)-EDV-Dox unless the subject becomes intolerant to investigational product (IP), withdraw consent or the individual is no longer receiving clinical benefit (factors taken in to consideration will be disease progression radiologically or clinically, and clinical benefits to quality of life). Tumour assessment will be repeated after each 7 week cycle (week 8).
The study will take place in two parts, Part 1 (Dose Exploration) and Part 2 (Dose Expansion).
Part 1 - Dose Exploration will assess the safety and tolerability of multiple doses of drug at two dose levels (5 x 10^9 and 8 x 10^9) and will enroll prior to Part 2. Three subjects will be recruited per dose level. Enrollment will begin with the 5 x 10^9 dose level, and the decision to enroll to the 8 x 10^9 dose level will follow a comprehensive safety evaluation and a standard 3 + 3 dose escalation study design.
Part 2 - Dose Expansion will be conducted pending safety results of Part 1 to provide guidance regarding the recommended phase 2 dose (RP2D). Subjects will be treated and assessed as outlined in Part 1 above. If 0 out of 3 subjects, or 1 out of 6 subjects, experience dose limiting toxicities (DLTs) at the 5 x 10^9 dose level in Part 1, additional subjects to a total of 10 will be recruited to this dose level in Part 2. Similarly, if 0 out of 3 subjects, or 1 out of 6 subjects, experience DLTs at the 8 x 10^9 dose level in Part 1, additional subjects to a total of 10 will be recruited to this dose level in Part 2. If both dose levels are tolerated, a total of 10 subjects per dose level will be enrolled.
A safety follow-up visit must be performed 30 (+5) days after the last dose of drug for all subjects.All subjects who discontinue investigational product and who have not withdrawn full consent to participate in the study will continue in the long term follow-up phase. Long term follow-up will continue approximately every 1 month for 12 months, from the 30 (+5) day follow-up visit, then approximately every 2-3 months for the extent of subject survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 dose escalation study
| Arm | Type | Receives |
|---|---|---|
| EGFR(V)-EDV-Dox | Experimental | Drug: EGFR(V)-EDV-DoxEGFR(V)-EDV-Dox administered via 20 minute intravenous infusion once a week for seven weeks (1 Cycle). Subjects will receive one of two dose levels: 5 x 10^9 or 8 x 10^9. All subjects will undergo an adapted dose escalation regime in the first cycle of treatment. For subsequent cycles all doses will be administered at full strength (5x10^9 or 8x10^9 EGFR(V)-EDV-Dox). Subjects may receive further cycles of treatment if the tumor remains stable or is responding, and/or they are deriving clinical benefit from the therapy and are tolerating treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Karnofsky Performance Status (KPS) ≥ 60%.
- Life expectancy ≥ 3 months.
- Pathologically documented, and definitively diagnosed recurrent World Health Organization (WHO) Grade IV astrocytoma (GBM).
- Participant must have archived tumor tissue available from initial diagnosis or subsequent relapse(s) of Grade IV GBM for submission for central review at Investigational sites local laboratories.
- Recurrence or progression of disease (confirmed by MRI and measurable by RANO criteria) following receipt of standard of care therapy, which includes maximum safe surgical resection, standard adjuvant radiation/temozolomide treatment. Participants must have completed at least 21 days of temozolomide treatment in combination with radiation therapy to be considered to have received standard of care therapy.
Key exclusion criteria (19 listed)
- History of central nervous system bleeding as defined by stroke or intraocular bleed within 6 months of enrollment.
- Evidence of acute intracranial / intra-tumoral hemorrhage, except for participants with stable grade 1 hemorrhage.
- History of coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association > Class II), uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100 mmHg) or cardiac arrhythmias requiring anti-arrrhythmic therapy.
- Clinically significant electrocardiogram (ECG) changes at enrollment which obscure the ability to assess the PR, QT, and QRS interval; congenital long QT syndrome.
- Active infection requiring treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGFR(V)-EDV-DoxAlso: EnGeneIC Dream Vector™, EnGeneIC Delivery Vehicle™EGFR(V)-EDV-Dox using EnGeneIC EDV™ technology is a bacterially derived minicell which packages a toxic payload, Doxorubicin, into a 400 nm particle which targets specific cancer cells using bispecific antibodies (BsAb). BsAb-targeted, payload-packaged EDV nanocells only exit the leaky blood vessels associated with tumors and enter into the tumor microenvironment. The BsAb binds to the tumor cell-surface receptor, where the EDV is taken up, broken down within the cancer cell and releases the Doxorubicin. The residual EDVs that do not make it into the tumor microenvironment, are engulfed by cells of the immune system and since the EDVs are derived from bacteria, they carry potent immuno-stimulating components which appear to bypass the immuno-suppression caused by the tumor. | Drug | EGFR(V)-EDV-Dox |
Primary outcome
Safety outcome measures
Time frame: Safety measures will be conducted from Study Day 1 as per study schedule to safety follow-up visit 30 (+5 days) post last dose.
Recording of adverse Events (AE's) and clinically significant changes in vital signs, physical and neurological examinations, cardiac tests, radiological imaging inc. CT scan (Day 27/28) and clinical laboratory tests.
3 secondary outcomes
Efficacy outcome measure
Time frame: Screening, then post cycle (Days 50-56)
Identification of a recommended Phase 2 dose (RP2D) of EGFR(V)-EDV-Dox in subjects with recurrent GBM
Time frame: DLT evaluable subjects are those who experience a DLT assessed within the first treatment cycle of Part 1 i.e.including up to 7 days after the final dose, days 1-50 of treatment.
Overall survival outcome measure
Time frame: The number of days from the date of first administration of EGFR(V)-EDV-Dox to the date of death, regardless of cause up to 60 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma
Not yet recruiting
A Single-Arm, Open-Label, Multicenter Clinical Study of Teniposide Combined With Temozolomide for the Treatment of Newly Diagnosed Glioblastoma (nGBM) With MGMT Promotor Region Unmethylated
Newly Diagnosed Glioblastoma, MGMT-Unmethylated Glioblastoma
Active, not recruitingPhase 1/2
Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma
Glioblastoma, Gliosarcoma
RecruitingPhase 2
Temozolomide, With or Without WSD0922-FU, for the Treatment of EGFR-Mutant, IDH-Wildtype Glioblastoma
Glioblastoma, IDH-Wildtype
Active, not recruitingPhase 1
Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma
Glioblastoma
Active, not recruitingPhase 2
A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden
Astrocytoma, IDH-Mutant, Grade 4, Diffuse Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer MacDiarmid, Ph.D study director
Engeneic Pty Limited
Himanshu Brahmbhatt, Ph. D study director
Engeneic Pty Limited
Gary L Gallia, M.D., Ph.D principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EGFR(V)-EDV-Dox in people with Glioblastoma and Astrocytoma, Grade IV, run by Engeneic Pty Limited at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety outcome measures (time frame: Safety measures will be conducted from Study Day 1 as per study schedule to safety follow-up visit 30 (+5 days) post last dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.