NeuroblastomaPhase 1NCT02982941
Enoblituzumab (MGA271) in Children With B7-H3-expressing Solid Tumors
A Phase 1 study testing Enoblituzumab in people with Neuroblastoma and Rhabdomyosarcoma, run by MacroGenics at 6 sites in United States.
Trial summary
This study is a Phase 1, open-label, dose escalation and cohort expansion trial designed to characterize the safety, tolerability, PK, PD, immunogenicity and preliminary antitumor activity of enoblituzumab administered IV on a weekly schedule for up to 96 doses (approximately 2 years) in children and young adults with… Read more about this study
- Who is it for?
- Ages 1 year to 35 years
- Conditions the study is for
- Neuroblastoma, Rhabdomyosarcoma, Osteosarcoma
- What is being tested?
- Enoblituzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2016to 22 May 2019
- 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 1 year to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Patients are to be excluded from the study if they have any of the following:
- Patients with a history of symptomatic central nervous system (CNS) unless they have been treated and are asymptomatic.
- Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment within the past 2 years, and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.
- History of prior allogeneic bone marrow/stem-cell or solid organ transplantation.
- Patients receiving autologous stem cell transplantation must wait 8 weeks before initiation of study drug administration.
- Treatment with systemic chemotherapy or investigational therapy within 4 weeks of first study drug administration; other agents (e.g., biologics) within 2 weeks; radiation within 2 weeks; patients receiving 131I-MIBG therapy must wait 6 weeks prior to the initiation of study drug administration; corticosteroids (≥ 0.2 mg/kg/day prednisone or equivalent) or other immune suppressive drugs within the 2 weeks prior to the initiation of study drug administration.
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- History of clinically significant cardiovascular disease
- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
- Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
- Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction.
- Second primary invasive malignancy that has not been in remission for greater than 2 years.
- History of severe trauma or major surgery within 4 weeks prior to the initiation of study drug administration.
- Known hypersensitivity to recombinant proteins, polysorbate 80 or any excipient contained in the drug formulation for enoblituzumab
- Patients in Canada may not have a history or evidence of latent or active tuberculosis infection.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
National Cancer Institute, Center for Cancer Research
Bethesda, Maryland, 20892
Texas Children's Hospital
Houston, Texas, 77030
University of Wisconsin, American Family Children's Hospital
Madison, Wisconsin, 53792
Lucile Packard Children's Hospital, Stanford
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Seattle Children's
Seattle, Washington, 98105
About this study
Official title: A Phase 1, Open-label, Dose Escalation Study of MGA271 in Pediatric Patients With B7-H3-Expressing Relapsed or Refractory Solid Tumors
This study is a Phase 1, open-label, dose escalation and cohort expansion trial designed to characterize the safety, tolerability, PK, PD, immunogenicity and preliminary antitumor activity of enoblituzumab administered IV on a weekly schedule for up to 96 doses (approximately 2 years) in children and young adults with B7-H3-expressing relapsed or refractory malignant solid tumors.
Read the detailed description
This study is a Phase 1, open-label, dose escalation and cohort expansion trial designed to characterize the safety, tolerability, PK, PD, immunogenicity and preliminary antitumor activity of enoblituzumab administered IV on a weekly schedule for up to 96 doses (approximately 2 years) in children and young adults with B7-H3-expressing relapsed or refractory malignant solid tumors.
The study consists of a Dose Escalation Phase to determine the MTD (or MAD) of enoblituzumab followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of enoblituzumab. In the cohort expansion phase, 5 cohorts of 10 patients each will be enrolled to further evaluate the safety and potential efficacy of enoblituzumab administered at the MTD/MAD in patients with:1) neuroblastoma - measurable disease, 2) neuroblastoma - non-measurable disease, 3) rhabdomyosarcoma, 4) osteosarcoma, and 5) Ewing's sarcoma, Wilms' tumor, desmoplastic small round cell tumors, or malignant solid tumors of any other histology that test positive for B7-H3.
All tumor evaluations will be carried out by both Response Evaluation Criteria in Solid Tumors (RECIST) and immune-related response criteria (irRC). Disease assessment in patients with neuroblastoma will use neuroblastoma overall response criteria.
- Conditions
- Neuroblastoma, Rhabdomyosarcoma, Osteosarcoma, Ewing Sarcoma, Wilms Tumor, Desmoplastic Small Round Cell Tumor
- Being tested
- Enoblituzumab
- Keywords
- Neuroblastoma, Rhabdomyosarcoma, Osteosarcoma, Ewing Sarcoma, Wilms Tumor, Desmoplastic Small Round Cell Tumor, pediatric
- Medical subject headings
- Neuroblastoma, Rhabdomyosarcoma, Osteosarcoma, Sarcoma, Ewing, Wilms Tumor, Desmoplastic Small Round Cell Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoblituzumabDrug
Also called MGA271
enoblituzumab administered IV weekly for up to 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation & Cohort Expansion | Experimental | enoblituzumab administered IV weekly Receives: Drug: Enoblituzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of enoblituzumab.
Adverse events, SAEs, incidence of treatment-emergent AE
Measured: Time of first dose through end of treatment (up to 2 years)
Secondary outcomes (3)
Peak plasma concentration
PK of enoblituzumab
Measured: Time of first dose through end of treatment (up to 96 weeks)
Number of participants that develop anti-drug antibodies
Proportion of patients who develop anti-MGA271 antibodies, immunogenicity
Measured: Time of first dose through end of treatment (up to 96 weeks)
Antitumor activity of enoblituzumab
Anti-tumor activity of enoblituzumab using conventional RECIST 1.1 and immune related RECIST criteria
Measured: Time of first dose through end of treatment (up to 96 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion22 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies 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
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, MacroGenics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982941
- Sponsor's protocol ID
- CP-MGA271-04
- Status last verified
- Feb 2022
- First submitted
- 30 Nov 2016
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose Escalation Study of MGA271 in Pediatric Patients With B7-H3-Expressing Relapsed or Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT02982941
- Acronym / sponsor ID
- CP-MGA271-04
- Conditions
- Neuroblastoma, Rhabdomyosarcoma, Osteosarcoma, Ewing Sarcoma, Wilms Tumor, Desmoplastic Small Round Cell Tumor
- Keywords
- Neuroblastoma, Rhabdomyosarcoma, Osteosarcoma, Ewing Sarcoma, Wilms Tumor, Desmoplastic Small Round Cell Tumor, pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 6 Dec 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.
This study is a Phase 1, open-label, dose escalation and cohort expansion trial designed to characterize the safety, tolerability, PK, PD, immunogenicity and preliminary antitumor activity of enoblituzumab administered IV on a weekly schedule for up to 96 doses (approximately 2 years) in children and young adults with B7-H3-expressing relapsed or refractory malignant solid tumors.
Detailed description
This study is a Phase 1, open-label, dose escalation and cohort expansion trial designed to characterize the safety, tolerability, PK, PD, immunogenicity and preliminary antitumor activity of enoblituzumab administered IV on a weekly schedule for up to 96 doses (approximately 2 years) in children and young adults with B7-H3-expressing relapsed or refractory malignant solid tumors.
The study consists of a Dose Escalation Phase to determine the MTD (or MAD) of enoblituzumab followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of enoblituzumab. In the cohort expansion phase, 5 cohorts of 10 patients each will be enrolled to further evaluate the safety and potential efficacy of enoblituzumab administered at the MTD/MAD in patients with:1) neuroblastoma - measurable disease, 2) neuroblastoma - non-measurable disease, 3) rhabdomyosarcoma, 4) osteosarcoma, and 5) Ewing's sarcoma, Wilms' tumor, desmoplastic small round cell tumors, or malignant solid tumors of any other histology that test positive for B7-H3.
All tumor evaluations will be carried out by both Response Evaluation Criteria in Solid Tumors (RECIST) and immune-related response criteria (irRC). Disease assessment in patients with neuroblastoma will use neuroblastoma overall response criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation & Cohort Expansion | Experimental | Drug: Enoblituzumabenoblituzumab administered IV weekly |
Who may qualify
- Ages
- 1 year to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Patients are to be excluded from the study if they have any of the following:
- Patients with a history of symptomatic central nervous system (CNS) unless they have been treated and are asymptomatic.
- Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment within the past 2 years, and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.
- History of prior allogeneic bone marrow/stem-cell or solid organ transplantation.
- Patients receiving autologous stem cell transplantation must wait 8 weeks before initiation of study drug administration.
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 |
|---|---|---|
| EnoblituzumabAlso: MGA271enoblituzumab administered IV weekly for up to 96 weeks | Drug | Dose Escalation & Cohort Expansion |
Primary outcome
Safety and tolerability of enoblituzumab.
Time frame: Time of first dose through end of treatment (up to 2 years)
Adverse events, SAEs, incidence of treatment-emergent AE
3 secondary outcomes
Peak plasma concentration
Time frame: Time of first dose through end of treatment (up to 96 weeks)
Number of participants that develop anti-drug antibodies
Time frame: Time of first dose through end of treatment (up to 96 weeks)
Antitumor activity of enoblituzumab
Time frame: Time of first dose through end of treatment (up to 96 weeks)
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 8 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Chief Medical Officer study director
MacroGenics
6 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 Enoblituzumab in people with Neuroblastoma and Rhabdomyosarcoma, run by MacroGenics at 6 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 0 inclusion and 14 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 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 and tolerability of enoblituzumab. (time frame: Time of first dose through end of treatment (up to 2 years)). 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 8 Feb 2022.