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New hope for brain tumor patients: targeted drug shows promise in early trial

NCT ID NCT03030066

Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This early-phase study tests a new drug called DS-1001b in 47 people with a specific type of brain tumor (glioma) that has an IDH1 gene mutation and has come back after standard treatments. The main goal is to check the drug's safety and how the body processes it, while also looking for signs that it might shrink or control the tumor. Participants must have a confirmed IDH1 mutation and measurable disease, but cannot have severe brain pressure or other active cancers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

47 people

The number who actually took part.

Started

Jan 2017

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Has histologically confirmed glioma with an IDH1-R132 mutation 2. Has disease that has recurred or progressed following standard treatment including radiotherapy 3. Has measurable lesion(s) as per RANO criteria 4. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: 1. Has significant symptoms of increased intracranial pressure 2. Has another active neoplasm 3. Has active infection requiring systemic treatment 4. Has a history of severe cardiac disease 5. Has had prior treatment with any inhibitor targeting mutant IDH1 6. Has had investigational drug treatment within 4 weeks prior to the first dose of study treatment 7. Is a pregnant or lactating female

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Conditions

The condition(s) this trial relates to.

glioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GLIOMA

Contacts and locations

Locations

  • National Cancer Center Hospital

    Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.