DSP-0390 for Brain Tumor

Not currently recruiting at 10 trial locations

Overseen By Reyna G Bishop, MS, RD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Sumitomo Dainippon Pharma Oncology, Inc

Must be taking: Antiepileptics, Corticosteroids

Must not be taking: CYP3A4 inhibitors, CYP2D6 inhibitors

Disqualifiers: Multifocal disease, Metastasis, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6-12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DSP-0390, an experimental therapy for patients with recurring high-grade glioma, an aggressive brain tumor. Researchers aim to determine if DSP-0390 can manage or shrink these tumors. The trial seeks participants living with this condition who have not recently received certain other treatments. Those stable on current medications may find this trial suitable. As a Phase 1 trial, the research focuses on understanding how DSP-0390 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, especially if they are strong or moderate CYP3A4 or CYP2D6 inhibitors or inducers. These should be discontinued at least 1 week or 5 half-lives before starting the study. If you are on antiepileptic drugs or corticosteroids, your dose must be stable before the study begins.

Is there any evidence suggesting that DSP-0390 is likely to be safe for humans?

Research shows that DSP-0390 is a new treatment being tested for safety and effectiveness. In lab studies, DSP-0390 demonstrated strong activity against brain tumors, suggesting potential effectiveness in humans. However, since this is an early stage of research, information on how well people tolerate the treatment remains limited.

The FDA has granted DSP-0390 "orphan drug designation," often given to promising treatments for rare diseases. This status does not confirm the drug's safety but indicates interest in its potential.

As this is an early phase study, researchers are beginning to test DSP-0390 in humans to assess its safety. The current focus is on determining a safe dose and monitoring for side effects. Specific information on how well people tolerate DSP-0390 is not yet available, so participants require close monitoring. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about DSP-0390 because it offers a new approach to treating brain tumors by being administered orally, which is less invasive compared to traditional treatments like surgery or intravenous chemotherapy. Unlike many existing therapies that often target the tumor from outside the brain, DSP-0390 is designed to be taken as a pill, potentially allowing it to pass through the blood-brain barrier more efficiently. This oral administration could provide a more convenient and targeted treatment option for patients, potentially improving both effectiveness and quality of life.

What evidence suggests that DSP-0390 might be an effective treatment for brain tumors?

Research has shown that DSP-0390 effectively targets brain tumors in lab studies using models that closely resemble human tumors. The treatment targets a protein that may aid tumor growth. Although these early results are promising, the current trial is studying DSP-0390's effectiveness in people. More research is needed to confirm its effectiveness for those with aggressive brain tumors. ^{1 2 3 5 6}

Who Is on the Research Team?

Jian Li, MD

Principal Investigator

Sumitomo Pharma America, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with recurrent high-grade glioma who have a good performance status, stable organ function, and no recent major surgeries or other cancer treatments. They must not have certain heart conditions, active infections (HIV/HCV/HBV), significant eye abnormalities, uncontrolled illnesses that could affect study participation, or be on conflicting medications. Women of childbearing potential and men must agree to use contraception.

Inclusion Criteria

I am mostly able to care for myself and carry out daily activities.

Agreement to use contraception or prevention of pregnancy measures for male or female patients of child-producing potential

I have recovered from previous cancer treatment side effects.

Exclusion Criteria

I haven't had treatments targeting blood vessel growth in the last 3 months.

I have not had lung inflammation or disease in the last 6 months.

I haven't had recent major surgery, brain bleeding, recent chemo or radiotherapy, and I'm not using prohibited meds or Optune.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DSP-0390 by oral administration. The treatment includes dose escalation and expansion phases to evaluate safety and efficacy.

6-12 months

Visits every 8 weeks for radiologic assessments and regular PK assessments during cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the assessment of adverse events and tumor activity.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DSP-0390

Trial Overview The trial is testing DSP-0390 in patients with recurrent high-grade brain tumors like glioblastoma. It aims to see how effective this drug is in treating the tumor and what side effects it may cause.

How Is the Trial Designed?

Group I: Single arm DSP-0390 Experimental Treatment 1 Intervention

Arm Description \[\*\] DSP-0390 by oral administration

Who Is Running the Clinical Trial?

Sumitomo Dainippon Pharma Oncology, Inc

Lead Sponsor

Trials

42

Recruited

6,800+

Sumitomo Pharma America, Inc.

Lead Sponsor

Trials

244

Recruited

51,500+

Jatin Shah

Sumitomo Pharma America, Inc.

Chief Medical Officer since 2024

MD from an unspecified institution

Tsutomu Nakagawa

Sumitomo Pharma America, Inc.

Chief Executive Officer since 2024

MBA from Waseda University

Sumitomo Pharma Oncology, Inc.

Lead Sponsor

Trials

45

Recruited

7,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06636162

Window of Opportunity Study of DSP-0390 in Gliomas This study focuses on determining the pharmacokinetic and pharmacodynamic effect of DSP-0390 in brain and blood from patients with IDH-mutant WHO grade II ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.TPS2077

DSP-0390, an oral emopamil binding protein (EBP) ... DSP-0390 has shown significant antitumor activity in orthotopic xenograft models of human GBM (data on file). Methods: DSP-0390 will be ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05023551

NCT05023551 | Study of DSP-0390 in Patients With ... This is a study of DSP-0390 in patients with recurrent high grade glioma. Detailed Description. This study will evaluate the safety and efficacy of DSP-0390 in ...

4. trials.braintumor.org trials.braintumor.org/trials/NCT05023551

Study of DSP-0390 in Patients With Recurrent High-Grade ... This study will evaluate the safety and efficacy of DSP-0390 in patients with recurrent high grade glioma. Arms & Interventions. Arms. Experimental: Single arm ...

5. withpower.com withpower.com/trial/dsp-0390-for-brain-tumors-70f8f

DSP-0390 for Brain Tumors This study focuses on determining the pharmacokinetic and pharmacodynamic effect of DSP-0390 in brain and blood from patients with IDH-mutant WHO grade II ...

6. onclive.com onclive.com/view/fda-grants-orphan-drug-designation-to-dsp-0390-for-brain-cancer

FDA Grants Orphan Drug Designation to DSP-0390 for ... The FDA has granted an orphan drug designation to DSP-0390 for the treatment of brain cancer, according to an announcement from Sumitomo Pharma Oncology.