Active — Not RecruitingEarly Phase 1

Study of DSP-0390 in Patients With Recurrent High-Grade Glioma

United States, Japan39 participantsStarted 2021-09-08

Plain-language summary

This is a study of DSP-0390 in patients with recurrent high grade glioma.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Pneumonitis or interstitial lung disease
. Any other lung condition that in the investigators' judgement may put the patient at an increased risk for lung toxicity (including, but not limited to, suspected interstitial lung disease or radiation-induced lung injury)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose Escalation: Assess safety of DSP-0390 by Incidence of TEAEs and SAEs in adult patients with recurrent high-grade glioma

Timeframe: From date of treatment through 30 days after End of Treatment an average of 6 months

Dose Escalation: Assess safety of DSP-0390 by severity of TEAEs and SAEs in adult patients with recurrent high-grade glioma

Timeframe: From date of treatment through 30 days after End of Treatment an average of 6 months

Dose Escalation: Determine the MTD and/or RDE of DSP-0390

Timeframe: From date of first treatment through Cycle 1 (28-day cycle) DLT monitoring period

Dose Expansion: Evaluate the change in Baseline tumor activity of DSP-0390 using radiologic assessments.

Timeframe: From date of first treatment, assessed by radiologic examination performed at 8-week intervals through study completion, an average of 6 months

Dose Expansion: Evaluate the safety of the Recommended Phase 2 Dose of DSP-0390 by assessment of incidence of TEAEs and SAEs

Timeframe: From date of first treatment through study completion, an average of 6 months

Dose Expansion: Evaluate the safety of the Recommended Phase 2 Dose by assessment of severity of TEAEs and SAEs

Trial details

NCT IDNCT05023551

SponsorSumitomo Pharma America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09-30

View on ClinicalTrials.gov More High Grade Glioma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Pneumonitis or interstitial lung disease
. Any other lung condition that in the investigators' judgement may put the patient at an increased risk for lung toxicity (including, but not limited to, suspected interstitial lung disease or radiation-induced lung injury)

What they're measuring

Dose Escalation: Assess safety of DSP-0390 by Incidence of TEAEs and SAEs in adult patients with recurrent high-grade glioma

Timeframe: From date of treatment through 30 days after End of Treatment an average of 6 months

Dose Escalation: Assess safety of DSP-0390 by severity of TEAEs and SAEs in adult patients with recurrent high-grade glioma

Timeframe: From date of treatment through 30 days after End of Treatment an average of 6 months

Dose Escalation: Determine the MTD and/or RDE of DSP-0390

Timeframe: From date of first treatment through Cycle 1 (28-day cycle) DLT monitoring period

Dose Expansion: Evaluate the change in Baseline tumor activity of DSP-0390 using radiologic assessments.

Timeframe: From date of first treatment, assessed by radiologic examination performed at 8-week intervals through study completion, an average of 6 months

Dose Expansion: Evaluate the safety of the Recommended Phase 2 Dose of DSP-0390 by assessment of incidence of TEAEs and SAEs

Timeframe: From date of first treatment through study completion, an average of 6 months

Dose Expansion: Evaluate the safety of the Recommended Phase 2 Dose by assessment of severity of TEAEs and SAEs