DSP-0390 for Brain Tumor

Recruiting at 9 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

39 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called DSP-0390 in patients with a type of brain cancer that has returned after treatment. The goal is to see if this drug can help stop or slow down the cancer.

Research Team

Jian Li, MD

Principal Investigator

Sumitomo Pharma America, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+