Phase 2 study for people with Brain Cancer

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor Day One Biopharmaceuticals, Inc.
Registry number NCT04775485
Started 22 April 2021 Today 16 October 2026 Estimated completion 31 May 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Queensland Children's Hospital Brisbane QLD Recruiting
Royal Children's Hospital Parkville VIC Recruiting
Perth Children's Hospital Perth WA Recruiting
Sydney Children's Hospital Randwick NSW Recruiting
The Children's Hospital at Westmead Westmead NSW Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 6 Months to 25 Years
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 141

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Low Grade Glioma \& Low-Grade Glioma Extension: a relapsed or progressive LGG with documented known activating BRAF alteration.

* Advanced Solid Tumor: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion.

* Participants must have histopathologic verification of malignancy at either original diagnosis or relapse.

* Must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression.

* Must have at least 1 measurable lesion as defined by RANO (Arms 1 \& 2) or RECIST v1.1 (Arm 3) criteria

Exclusion Criteria:

* Participant's tumor has additional previously-known activating molecular alterations.

* Participant has symptoms of without radiographically recurrent or radiographically progressive disease.

* Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) via genetic testing or current diagnostic criteria.

Other inclusion/exclusion criteria as stipulated by protocol may apply

Dates on the record

Started 22 April 2021
Estimated completion 31 May 2027
Registry last updated 10 April 2025
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 10 April 2025.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.