DIPGPhase 1NCT05063357
131I-omburtamab Delivered by Convection-Enhanced Delivery in Patients With Diffuse Intrinsic Pontine Glioma
A Phase 1 study testing 131I-Omburtamab and Convention Enhanced Delivery in people with DIPG, run by Y-mAbs Therapeutics.
Trial summary
Omburtamab is a murine IgG1 monoclonal antibody, recognizing CD276 (also known as B7- H3). Omburtamab is 131I-labeled at designated radio pharmacies and will be provided as a final radiolabeled product to treatment site. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- DIPG
- What is being tested?
- 131I-Omburtamab and Convention Enhanced Delivery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Dec 2026
- 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 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of diffuse intrinsic pontine glioma based on clinical evidence and radiographic (MRI) imaging.
- The patient must have undergone prior external beam radiotherapy using standard conformal fractionated or hypo-fractionated techniques to a planned maximal total dose of 54-60 Gy to the brain stem of which the patient must have received ≥ 90% of the planned dose, at least 4 weeks but no more than 14 weeks prior signing of ICF.
- Lansky or Karnofsky Performance Score of ≥ 70 at study entry. Lansky Performance scale to be used for patients ≤16 years of age.
- Age ≥ 3 years old and less than 21 years old.
- Written informed consent from legal guardian(s) and/or child obtained in accordance with local regulations. Pediatric patients must provide assent as required by local regulations.
Who cannot join
- Clinical and/or radiographic (MRI) progression of tumor in the period between external beam radiation therapy and signing of ICF. If pseudoprogression is suspected rescreening is allowed
- Metastatic or disseminated disease.
- Tumor size larger than 20cm3.
- Untreated symptomatic hydrocephalus as determined by the investigator
- Increasing dose of steroids for 1 week prior to first IMP treatment
- AST or ALT > 3x the upper limit of normal.
Show all 20Show fewer
- Total bilirubin > 3x the upper limit of normal. In case either AST or ALT ≥3 x ULN, bilirubin must be ≤ 2 x the upper limit of normal.
- Hemoglobin less than 8 g/dL.
- White blood cell (WBC) count less than 1000/μL.
- ANC count less than 500/μL.
- Platelet count less than 100,000/μL.
- INR (international normalized ratio) higher than 1.5 (calculated from the prothrombin time).
- Glomerular filtration rate (eGFR) of ≤ 60 ml/min/1.73m2 calculated by 2009 revised Bedside Schwartz Equation.
- Weight less than 8kg.
- Life expectancy less than six weeks as judged by the investigator.
- Tumor whose origin is outside the pons.
- Patients must not have an uncontrolled life-threatening infection.
- Patients must not have severe non-hematologic organ or neurological toxicity; specifically, any neurological, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity must be below Grade 3 prior to signing the ICF.
- Females of childbearing potential who are pregnant, breast feeding, intend to become pregnant, or are not using highly effective contraceptive methods while included in the trial and for 12 months after the last dose of 131I-omburtamab.
- Fertile male patients who do not agree to the use of condoms during treatment and for a period of 12 months after the last dose of 131I-omburtamab. For a male patient to be exempt from the requirement to use contraception after 131I-omburtamab treatment, he must have undergone surgical sterilization (vasectomy).
About this study
Official title: Safety of 131I-omburtamab Delivered by Convection-Enhanced Delivery in Patients With Diffuse Intrinsic Pontine Glioma Previously Treated With External Beam Radiation Therapy
Omburtamab is a murine IgG1 monoclonal antibody, recognizing CD276 (also known as B7- H3). Omburtamab is 131I-labeled at designated radio pharmacies and will be provided as a final radiolabeled product to treatment site. The proposed intervention includes surgical placement using standard stereotactic techniques of a small caliber cannula into the tumor in the pons followed by positive pressure infusion (i.e. CED) of 131I-omburtamab. Iodine-131 conjugated omburtamab (131I-omburtamab) administered via the intracerebroventricular route for the treatment of metastatic CNS neuroblastoma was shown to be tolerable and improve survival. Furthermore, 124I-omburtamab administered by convection enhanced delivery (CED) was shown to have a tolerable safety profile in an ongoing dose escalation trial (in doses up to 4mCi) in patients with diffuse pontine gliomas that have not progressed following external beam radiation therapy. The aim of this trial is to determine the efficacy and safety of 131I-omburtamab in patients with DIPG that have not progressed following external beam radiation therapy.
Read the detailed description
The IMP infusion volume for CED will be adjusted to 4, 6 or 8 mL dependent on the size of the tumor as estimated by MRI. The maximum volume of 8 mL was tested, and safety cleared in the 11-011 trial. Assuming a ratio of approximately 1:3 between the infusion volume and the distribution volume the infusion volume will be adjusted to ensure coverage of the tumor and 0.5 cm of the surrounding margin. The infusion volume will be 4 mL if tumor size (+0.5 cm margin) <10 cm3, 6 mL if tumor size (+0.5 cm margin) ≥10 and <15 cm3, and 8 mL if tumor size (+0.5 cm margin) ≥15 and ≤20 cm3. The maximum infusion rate will be 10 μL/min. Infusions will be initiated using an escalating flow rate plan with 10-min intervals until the maximum rate is achieved (0·5 μL/min, 1·0 μL/min, 2·0 μL/min, 5·0 μL/min, 7·5 μL/min and 10 μL/min).
- Conditions
- DIPG
- Being tested
- 131I-Omburtamab, Convention Enhanced Delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
131I-OmburtamabDrug
Omburtamab is a murine IgG1 monoclonal antibody, recognizing CD276 (also known as B7-H3).
Convention Enhanced DeliveryDevice
The planned intervention includes surgical placement of a small caliber cannula into the tumor located in the pons using standard stereotactic techniques followed by CED of 131Iomburtamb.
| Study group | Role | What they receive |
|---|---|---|
| Radioactive iodine-labeled monoclonal antibody omburtamab | Other | Single arm Receives: Drug: 131I-Omburtamab; Device: Convention Enhanced Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the safety of up to 36 participants with 131I-omburtamab administered directly into the tumor by CED in patients with DIPG assessed by CTCAE v.5.0
Up to 36 patients may be enrolled in the dose escalation phase in planned cohorts of 3 patients with a maximum of 3 cohorts at a dose level.All patients may receive up to three cycles of 131I-omburtamab. Patients will be followed until the last patient has had the last follow-up visit at 2 years after the 131I-omburtamab administration. End of trial is defined as last patient's last visit in the two-year follow-up period, or death whichever comes first. All Non-serious AEs should be reported from the time of CED placement surgery administration until 30 days after the IMP administration. All SAEs should be captured from signing the ICF until 30 days after IMP administration. Starting at day 31 after dosing of 131I-omburtamab only SAE's or ≥ grade 3 non-serious AEs considered at least possibly related to 131I-omburtamab or new onset of cancers regardless of causality should be reported.
Measured: 2 years after last patient has received final dose of 131I-omburtamab administration
Secondary outcomes (11)
Progression of tumor using Magnetic Resonance Imaging (MRI) of the brain in accordance with recommendations from the Response Assessment in Pediatric Neuro-Oncology (RAPNO) working group for Diffuse Intrinsic Pontine Glioma (DIPG)
MRI of the brain will be used to assess PD.
PD is defined as:
A greater than 25 percent increase in the 2D product of the perpendicular diameters of the lesion using T2-weighted or FLAIR sequences and not considered pseudo-progression, taking as a reference the smallest disease measurement recorded since the baseline MRI OR the appearance of new extrapontine tumor, i.e. lesions non-contiguous to the primary pontine lesion.
Measured: 60 months
Progression of tumor using Magnetic Resonance Imaging (MRI) of the spine in accordance with recommendations from the Response Assessment in Pediatric Neuro-Oncology (RAPNO) working group for Diffuse Intrinsic Pontine Glioma (DIPG)
MRI of the spine will be used to assess PD.
PD is defined as:
A greater than 25 percent increase in the 2D product of the perpendicular diameters of the lesion using T2-weighted or FLAIR sequences and not considered pseudo-progression, taking as a reference the smallest disease measurement recorded since the baseline MRI OR the appearance of new extrapontine tumor, i.e. lesions non-contiguous to the primary pontine lesion.
Measured: 60 months
Gross neurological investigation including the cranial nerves by physical examination and the Neurologic Assessment in Neuro-Oncology (NANO) scale.
Neurological examination indicating clinical deterioration not attributable to other causes such as anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, etc.
PD is defined as:
A greater than 25 percent increase in the 2D product of the perpendicular diameters of the lesion. The scale is intended to be performed at baseline and at follow-up visits. An overall score will be determined following assessment of each domain and will include one of 5 possible outcomes: neurologic response, neurologic progression, neurologic stability, not assessed, and non-evaluable.
Neurologic response is defined as a ≥2 level improvement in at least one domain without worsening in other domains from baseline.
Neurologic stability indicates a score of neurologic function that does not meet criteria for neurologic response, neurologic progression, non-evaluable, or not assessed.
Measured: 60 months
SPECT/CT scans and blood sampling for dosimetry
SPECT/CT scans will be performed at 4h, 12h, 24h, 72h and 7 days after the first administration of 131I-omburtamab.
Measured: 7 days
Blood sampling for dosimetry
will be performed at 4h, 12h, 24h, 72h and 7 days after the first administration of 131I-omburtamab.
Measured: 7 days
Changes in neurological function using the Neurologic Assessment in Neuro-Oncology scale
Changes in neurological function will be assessed 1, 2, 7, 14, and 30 days after dosing with 131I-omburtamab by summarizing changes from baseline of a neurological examination using the Neurologic Assessment in Neuro-Oncology (NANO) scale. The NANO scale is intended to be performed at baseline and at follow-up visits, especially those where neuroimaging is obtained. An overall NANO score will be determined following assessment of each domain and will include one of 5 possible outcomes: neurologic response, neurologic progression, neurologic stability, not assessed, and non-evaluable. In general, assessment and scoring of all domains is encouraged.
Measured: Up to 30 days after dosing with 131I-omburtamab
Changes from baseline in the Lansky/Karnofsky performance score
Changes from baseline in the Lansky/Karnofsky performance score evaluated 6, 12, and 24 months after last dosing. Lansky or Karnofsky Performance Score of ≥ 70 at study entry. Lansky Performance scale to be used for patients ≤16 years of age. The score is determined on a scale ranging from 0-100. A higher score means the patient is better able to carry out daily activities.
Measured: 24 months after last dosing
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Monitoring the frequency, type, and duration of serious adverse events after up to 3 CED infusions of 131I-omburtamab
Measured: 30 days after the last IMP administration.
Overall Survival
Overall survival will be followed as a secondary efficacy endpoint dictated by the absence of suitable and validated surrogate markers of efficacy in DIPG.
Measured: Up to 24 months after first CED infusion of 131I-omburtamab
Progression free survival
Response Assessment in Pediatric Neuro-Oncology (RAPNO) and Response Assessment in Pediatric Neuro-Oncology High Grade Glioma (RAPNO-HCG) will be used to assess progression free survival.
Measured: Up to 12 months after first CED infusion of 131I-omburtamab
Objective Response Rate
Response Assessment in Pediatric Neuro-Oncology (RAPNO) and Response Assessment in Pediatric Neuro-Oncology High Grade Glioma (RAPNO-HCG) will be used to assess objective response rate at 6 months and 12 months after first CED infusion of 131I-omburtamab.
Measured: 12 months after first CED infusion of 131I-omburtamab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study startMar 2022 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Corporate business decision. Not due to safety or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DIPGStudies 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
- Single-arm, multi-center clinical trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Y-mAbs Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Labcorp Corporation of America Holdings, Inc, Invicro
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063357
- Sponsor's protocol ID
- 102
- Status last verified
- Jun 2023
- First submitted
- 16 Sep 2020
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of 131I-omburtamab Delivered by Convection-Enhanced Delivery in Patients With Diffuse Intrinsic Pontine Glioma Previously Treated With External Beam Radiation Therapy
- ClinicalTrials.gov ID
- NCT05063357
- Acronym / sponsor ID
- 102
- Conditions
- DIPG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Corporate business decision. Not due to safety or efficacy concerns.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Y-mAbs TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Labcorp Corporation of America Holdings, Inc, Invicro
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Oct 2021 (actual)
- 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.
Omburtamab is a murine IgG1 monoclonal antibody, recognizing CD276 (also known as B7- H3). Omburtamab is 131I-labeled at designated radio pharmacies and will be provided as a final radiolabeled product to treatment site. The proposed intervention includes surgical placement using standard stereotactic techniques of a small caliber cannula into the tumor in the pons followed by positive pressure infusion (i.e. CED) of 131I-omburtamab. Iodine-131 conjugated omburtamab (131I-omburtamab) administered via the intracerebroventricular route for the treatment of metastatic CNS neuroblastoma was shown to be tolerable and improve survival. Furthermore, 124I-omburtamab administered by convection enhanced delivery (CED) was shown to have a tolerable safety profile in an ongoing dose escalation trial (in doses up to 4mCi) in patients with diffuse pontine gliomas that have not progressed following external beam radiation therapy. The aim of this trial is to determine the efficacy and safety of 131I-omburtamab in patients with DIPG that have not progressed following external beam radiation therapy.
Detailed description
The IMP infusion volume for CED will be adjusted to 4, 6 or 8 mL dependent on the size of the tumor as estimated by MRI. The maximum volume of 8 mL was tested, and safety cleared in the 11-011 trial. Assuming a ratio of approximately 1:3 between the infusion volume and the distribution volume the infusion volume will be adjusted to ensure coverage of the tumor and 0.5 cm of the surrounding margin. The infusion volume will be 4 mL if tumor size (+0.5 cm margin) <10 cm3, 6 mL if tumor size (+0.5 cm margin) ≥10 and <15 cm3, and 8 mL if tumor size (+0.5 cm margin) ≥15 and ≤20 cm3. The maximum infusion rate will be 10 μL/min. Infusions will be initiated using an escalating flow rate plan with 10-min intervals until the maximum rate is achieved (0·5 μL/min, 1·0 μL/min, 2·0 μL/min, 5·0 μL/min, 7·5 μL/min and 10 μL/min).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, multi-center clinical trial
| Arm | Type | Receives |
|---|---|---|
| Radioactive iodine-labeled monoclonal antibody omburtamab | Other | Drug: 131I-Omburtamab, Device: Convention Enhanced DeliverySingle arm |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosis of diffuse intrinsic pontine glioma based on clinical evidence and radiographic (MRI) imaging.
- The patient must have undergone prior external beam radiotherapy using standard conformal fractionated or hypo-fractionated techniques to a planned maximal total dose of 54-60 Gy to the brain stem of which the patient must have received ≥ 90% of the planned dose, at least 4 weeks but no more than 14 weeks prior signing of ICF.
- Lansky or Karnofsky Performance Score of ≥ 70 at study entry. Lansky Performance scale to be used for patients ≤16 years of age.
- Age ≥ 3 years old and less than 21 years old.
- Written informed consent from legal guardian(s) and/or child obtained in accordance with local regulations. Pediatric patients must provide assent as required by local regulations.
Key exclusion criteria (20 listed)
- Clinical and/or radiographic (MRI) progression of tumor in the period between external beam radiation therapy and signing of ICF. If pseudoprogression is suspected rescreening is allowed
- Metastatic or disseminated disease.
- Tumor size larger than 20cm3.
- Untreated symptomatic hydrocephalus as determined by the investigator
- Increasing dose of steroids for 1 week prior to first IMP 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 |
|---|---|---|
| 131I-OmburtamabOmburtamab is a murine IgG1 monoclonal antibody, recognizing CD276 (also known as B7-H3). | Drug | Radioactive iodine-labeled monoclonal antibody omburtamab |
| Convention Enhanced DeliveryThe planned intervention includes surgical placement of a small caliber cannula into the tumor located in the pons using standard stereotactic techniques followed by CED of 131Iomburtamb. | Device | Radioactive iodine-labeled monoclonal antibody omburtamab |
Primary outcome
Determining the safety of up to 36 participants with 131I-omburtamab administered directly into the tumor by CED in patients with DIPG assessed by CTCAE v.5.0
Time frame: 2 years after last patient has received final dose of 131I-omburtamab administration
Up to 36 patients may be enrolled in the dose escalation phase in planned cohorts of 3 patients with a maximum of 3 cohorts at a dose level.All patients may receive up to three cycles of 131I-omburtamab. Patients will be followed until the last patient has had the last follow-up visit at 2 years after the 131I-omburtamab administration. End of trial is defined as last patient's last visit in the two-year follow-up period, or death whichever comes first. All Non-serious AEs should be reported from the time of CED placement surgery administration until 30 days after the IMP administration. All SAEs should be captured from signing the ICF until 30 days after IMP administration. Starting at day 31 after dosing of 131I-omburtamab only SAE's or ≥ grade 3 non-serious AEs considered at least possibly related to 131I-omburtamab or new onset of cancers regardless of causality should be reported.
11 secondary outcomes
Progression of tumor using Magnetic Resonance Imaging (MRI) of the brain in accordance with recommendations from the Response Assessment in Pediatric Neuro-Oncology (RAPNO) working group for Diffuse Intrinsic Pontine Glioma (DIPG)
Time frame: 60 months
Progression of tumor using Magnetic Resonance Imaging (MRI) of the spine in accordance with recommendations from the Response Assessment in Pediatric Neuro-Oncology (RAPNO) working group for Diffuse Intrinsic Pontine Glioma (DIPG)
Time frame: 60 months
Gross neurological investigation including the cranial nerves by physical examination and the Neurologic Assessment in Neuro-Oncology (NANO) scale.
Time frame: 60 months
SPECT/CT scans and blood sampling for dosimetry
Time frame: 7 days
Blood sampling for dosimetry
Time frame: 7 days
Changes in neurological function using the Neurologic Assessment in Neuro-Oncology scale
Time frame: Up to 30 days after dosing with 131I-omburtamab
Changes from baseline in the Lansky/Karnofsky performance score
Time frame: 24 months after last dosing
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 30 days after the last IMP administration.
Overall Survival
Time frame: Up to 24 months after first CED infusion of 131I-omburtamab
Progression free survival
Time frame: Up to 12 months after first CED infusion of 131I-omburtamab
Objective Response Rate
Time frame: 12 months after first CED infusion of 131I-omburtamab
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 131I-Omburtamab and Convention Enhanced Delivery in people with DIPG, run by Y-mAbs Therapeutics.
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 5 inclusion and 20 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: withdrawn, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Determining the safety of up to 36 participants with 131I-omburtamab administered directly into the tumor by CED in patients with DIPG assessed by CTCAE v.5.0 (time frame: 2 years after last patient has received final dose of 131I-omburtamab administration). 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 26 Jun 2023.