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GlioblastomaPhase 1/2NCT02750891

A Study of DSP-7888 in Pediatric Patients With Relapsed or Refractory High Grade Gliomas

A Phase 1/2 study testing DSP-7888 in people with Glioblastoma and Diffuse Intrinsic Pontine Glioma, run by Sumitomo Pharma Co., Ltd. at 6 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with recurrent and relapsed diffuse intrinsic pontine glioma, glioblastoma, or grade III or IV glioma. Read more about this study

Who is it for?
Ages Up to 19 years
What is being tested?
DSP-7888
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
6 sitesJapan
Study dates
Apr 2016to Jan 2020
Phase
Phase 1/2
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 Up to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients meeting any of the conditions a) to c) below:
  • Have a diagnosis of diffuse intrinsic pontine glioma on the basis of imaging findings on magnetic resonance imaging (MRI) and clinical course
  • Have histologically or cytologically confirmed glioblastoma
  • Not meeting a) and b) above, but have histologically or cytologically confirmed grade III or IV glioma
  • Patients who will be able to be hospitalized from the initial dose of DSP-7888 until the end of the post-initial dose observation (In Phase 1 part only, patients may be permitted to have a temporary overnight leave during the hospitalization.)
  • Patients aged < 20 years at the time of informed consent
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  • Patients for whom either the legally acceptable representative or the patient (if aged ≥ 16 years) have provided written voluntary consent to participation in this study after fully receiving and understanding the information about this study, including study objectives, contents, expected pharmacological actions and effects, and foreseeable risks
  • Patients for whom standard therapy failed or no standard therapy is established
  • Diffuse intrinsic pontine glioma patients must received radiotherapy-based treatment or chemotherapy (if radiotherapy is not indicated) at least one cycle and subsequently had tumor enlargement accompanied by tumor-related symptomatic worsening (except for worsening due to dose reduction of steroid therapy for brain edema)
  • Glioblastoma patients and grade III or IV glioma patients must had radiologically evident tumor re-enlargement or recurrence
  • Patients with an ECOG PS score of 0 to 2 at enrollment. Patients with a PS score of 3 or 4 due to neurological symptoms associated with the primary disease may be eligible if appropriate in the opinion of the investigator or subinvestigator.
  • Patients with a life expectancy of 2 months (60 days)
  • Patients with a HLA type of HLA-A*24:02 or A*02:01/06
  • Patients with adequate major organ functions meeting the following criteria on the basis of laboratory data within 28 days before enrollment:
  • Neutrophil count: 1000/μL Platelet count: 5.0 ×104/μL Hemoglobin: 9.0 g/dL Serum creatinine: 2-fold the upper limit of the normal range of the study site (ULN) Total bilirubin: 2-fold the ULN AST, ALT: 3-fold the ULN
  • Female patients of childbearing potential must have a negative pregnancy test within 4 weeks (28 days) before enrollment
  • Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use appropriate contraception from the time of consent until 180 days after the last dose of the study drug to avoid pregnancy

Who cannot join

  • Patients with grade 3 infection according to the CTCAE v4.0
  • Patients with a positive test result for HIV antibody, HBs antigen, or HCV antibody
  • Patients with multiple or disseminated primary lesions (Multiple nodules in the same tumor cavity will be acceptable.)
  • Patients with other malignancies
  • Patients with significant diseases at enrollment that may affect study treatment, such as New York Heart Association (NYHA) Functional Class III or IV heart disease, CTCAE v4.0 grade 3 arrhythmia, angina pectoris, abnormal electrocardiogram findings, interstitial pneumonia or pulmonary fibrosis
  • Patients with uncontrollable complications
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  • Patients who underwent allogeneic hematopoietic stem cell transplant
  • Patients who received any of the following treatments within the specified period before enrollment
  • Nitrosoureas, mitomycin C: <42 days
  • Chemotherapy (including molecular-targeted drugs), radiotherapy: <21 days
  • Surgery, blood transfusion, erythropoiesis-stimulating drugs, endocrine therapy, immunotherapy (including biological response modifier [BRM] therapy): <14 days
  • Pregnant or breastfeeding women
  • Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, or patients who require long-term systemic steroid therapy (excluding therapy given on a PRN basis). However, steroid therapy for brain edema (prednisolone-equivalent dose of 30 mg/m2) and steroid replacement therapy at a physiologic dose will be acceptable.
  • Patients with any ongoing CTCAE v4.0 grade 2 adverse effects of prior treatment (excluding alopecia and phlebitis)
  • Patients who received any other investigational product or post-marketing study drug within 4 weeks (28 days) before enrollment
  • Patients with a history of allergy to any oil-based agents
  • Patients who previously received DSP-7888-containing WT1 peptide, or WT1 immunotherapy
  • Patients who are inappropriate for participation in the study for other reasons in the opinion of the investigator or subinvestigator

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Japan6 sites

  • Hiroshima University Hospital

    Hiroshima

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken

  • Osaka City General Hospital

    Osaka

  • National Center for Child Health and Development

    Setagaya City, Tokyo

  • Osaka University Hospital

    Suita, Osaka

  • Kanagawa Children's Medical Center

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Phase 1/2 Study of DSP-7888 in Pediatric Patients With Relapsed or Refractory High Grade Gliomas

This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with recurrent and relapsed diffuse intrinsic pontine glioma, glioblastoma, or grade III or IV glioma.

Being tested
DSP-7888
Keywords
high grade glioma, HGG, DIPG
Medical subject headings
Glioblastoma, Diffuse Intrinsic Pontine Glioma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DSP-7888Drug

    Phase1 portion: 1.75 or 3.5 mg/body, Id every 1-4 weeks Phase 2 portion: recommended phase 2 dose, Id every 1-4 weeks

Study groups in NCT02750891
Study groupRoleWhat they receive
DSP-7888ExperimentalNot described
Receives: Drug: DSP-7888

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT (dose-limiting toxicity)

    Safety and tolerability assessed by dose-limiting toxicity (DLT)

    Measured: 4 weeks

  2. Overall Survival （OS）

    Participants follow-up for overall survival will occur. Maximum follow-up time is 2 year after the initial administration of the last subject.

    Measured: 24 months

Secondary outcomes (9)

  1. Overall Response Rate（ORR）

    Antitumor effect as assessed according to the Response Assessment in Neuro-Oncology (RANO) criteria

    Measured: 6 months

  2. Progression-free survival (PFS)

    Measured: 6 months

  3. adverse events (AEs)

    Safety and tolerability assessed by adverse events (AEs)

    Measured: 12 months

  4. serious adverse events (SAEs)

    Safety and tolerability assessed by serious adverse events (SAEs)

    Measured: 12 months

  5. DTH （delayed-type hypersensitivity）

    Explore efficacy related biomarkers assessed by delayed-type hypersensitivity (DTH) reactions to WT1 peptide

    Measured: 6 months

  6. WT1 peptide-specific CTL-induction activity

    Explore efficacy related biomarkers assessed by WT1 peptide-specific CTL-induction activity.

    Measured: 6 months

  7. expression of WT1 in biopsy tissues

    Explore efficacy related biomarkers assessed in biopsy tissues

    Measured: 6 months

  8. expression of HLA in biopsy tissues

    Explore efficacy related biomarkers assessed in biopsy tissues

    Measured: 6 months

  9. expression of PD-L1 in biopsy tissues

    Explore efficacy related biomarkers assessed in biopsy tissues

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionJan 2020
  4. Study completionJan 2020

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02750891
Sponsor's protocol ID
DB601001
Other IDs
JapicCTI-163216
Status last verified
Apr 2022
First submitted
13 Apr 2016
Last updated
12 Apr 2022
Results posted
No

Publications

  • Hashii Y, Fujisaki H, Terashima K, Goto H, Horibe K, Sugiyama K, Takahara-Matsubara M, Goto M, Yanagisawa T, Kikuta A, Kawamoto H, Hashimoto N, Oka Y, Sugiyama H, Hara J. Phase 1/2 study of a WT1 peptide-dosing emulsion in pediatric patients with recurrent/refractory diffuse intrinsic pontine glioma, glioblastoma, or anaplastic astrocytoma. Eur J Cancer. 2026 Jun 25;242:116808. doi: 10.1016/j.ejca.2026.116808. Epub 2026 May 19.

    PubMed 42176363

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DSP-7888 in people with Glioblastoma and Diffuse Intrinsic Pontine Glioma, run by Sumitomo Pharma Co., Ltd. at 6 sites in Japan.

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 17 inclusion and 18 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 12 Apr 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 Japan. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

DLT (dose-limiting toxicity) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02750891, which also lists 1 linked publication.

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 12 Apr 2022.

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