Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for brain tumor patients when standard drug fails

NCT ID NCT07703436

Disease control Sponsor: Nuvation Bio Inc. 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Aug 28, 2026 · Updated 7 times

Summary

This study tests an experimental drug called safusidenib in people with a slow-growing brain tumor (IDH1-mutant glioma) whose tumor got worse while on the standard drug vorasidenib. Up to 40 participants take safusidenib pills twice daily to see if the tumor shrinks or stops growing. The goal is to find a backup option for patients who run out of effective treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
safusidenib
What this could lead to
If safusidenib works, it could offer a new treatment option for people with IDH1-mutant glioma whose tumors stop responding to the current standard drug.
What could go wrong
This is a small, early-phase trial with only 40 participants, so results may not apply to everyone. The drug may not shrink tumors or could cause side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2027

An estimate. Start dates often move.

Expected to finish

Mar 2032

An estimate. End dates often move.

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

18 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.

Key Inclusion Criteria: * Histologically confirmed Grade 2 or 3 IDH-mutant astrocytoma or IDH-mutant and 1p19q co-deleted oligodendroglioma, according to WHO CNS 2021 criteria * IDH1 mutation (e.g., R132H/C/G/S/L) based on immunohistochemistry (IHC) (R132H only), PCR, or next generation sequencing (NGS). * Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection). * Measurable disease per modified RANO 2.0 confirmed by BICR during Screening. * Previously treated with vorasidenib and experienced radiographic disease progression during treatment and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator. Disease progression must be confirmed by BICR using modified RANO 2.0. * Adequate hematologic and organ function * Expected survival of ≥12 months Key Exclusion Criteria: * Any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) and vorasidenib for treatment of glioma. * Discontinued vorasidenib for toxicity or any reason other than radiographic disease progression * Prior treatment with anti-angiogenic agents such as Avastin (bevacizumab) or investigational agents for glioma. * Brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension. * Significant functional or neurocognitive deficits, including uncontrolled seizures * Evidence of leptomeningeal disease. * Use of therapeutic doses of steroids for signs/symptoms of glioma. Participants taking physiologic doses (defined as equivalent of \<1.5 mg of dexamethasone equivalent) for medical conditions not related to glioma will be permitted.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Astrocytoma, IDH-mutant, grade 2 are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

astrocytoma, IDH-mutant, grade 2 astrocytoma, IDH-mutant, grade 3 glioma IDH-mutant anaplastic astrocytoma IDH-mutant and 1p/19q-codeleted oligodendroglioma oligodendroglioma

As listed by the trial registrant

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

Astrocytoma, IDH-mutant, grade 2 Astrocytoma, IDH-mutant, grade 3 GLIOMA Grade 2 IDH1-mutant glioma Grade 3 IDH1-mutant glioma IDH1-mutant glioma Oligodendroglioma Oligodendroglioma IDH-1 mutant and 1/P19Q-codeleted

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    7 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University Medical Center

    New York, New York, 10032, United States

    Contact Email: •••••@•••••

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Rutgers Cancer Institute

    New Brunswick, New Jersey, 08901, United States

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • Yale University

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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