Phase 1 Brain Cancer Trial, Recruiting NCT05789394 Sponsor: Mayo Clinic Condition: Brain Cancer
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Phase 1 Brain Cancer Trial, Recruiting

NCT05789394
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older
  • People whose general health and ability to function meets a minimum level, as measured by a standard scale called the Karnofsky Performance Scale (score of 60 or above) (confirm with trial site)
  • People who have previously been diagnosed with a specific type of brain tumour — either glioblastoma multiforme (IDH wildtype) or astrocytoma (IDH-mutant, WHO grade IV) — based on tissue testing, according to the 2021 WHO brain tumour classification
  • People whose brain tumour has come back and who are planned to have surgery (a repeat craniotomy) to remove the recurring tumour
  • People whose tumour is measurable using standard brain tumour imaging assessment guidelines
  • People whose kidneys are functioning within an acceptable range, based on blood tests taken within 3 weeks before joining the trial
  • People whose liver is functioning within an acceptable range, based on blood tests taken within 3 weeks before joining the trial
  • People whose blood clotting levels are within an acceptable range, based on blood tests taken within 3 weeks before joining the trial
  • People whose blood counts (red blood cells, platelets, and infection-fighting white blood cells) are within acceptable levels, based on blood tests taken within 3 weeks before joining the trial
  • People who are able to return to the enrolling hospital for follow-up visits during the active study period
  • People (or their legally authorised representative) who are able to fully understand and sign written and verbal consent for the study
  • People willing to provide blood samples for research purposes as required by the study
  • People willing to provide tissue samples for research purposes as required by the study
  • People willing to have a small device called an Ommaya reservoir placed (a device used to collect fluid from around the brain) and to provide those fluid samples for research purposes
  • For people who could become pregnant: a negative pregnancy test taken within 7 days before joining the trial is required

Who may not be able to join:

  • People who are only having a needle biopsy, or who are not suitable for surgical treatment
  • People whose tumour is located only in certain deep brain regions (the brain stem, midbrain, or thalamus) without involving the surrounding brain tissue
  • People who have previously been treated with bevacizumab (a type of cancer medication)
  • People whose scans show the cancer has spread along the lining of the brain or spinal cord (called leptomeningeal disease)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Alfredo Quinones-Hinojosa, MD, Mayo Clinic

Phone: 855-776-0015

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
16 June 2023
Est. completion
24 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Maximum tolerated dose (MTD)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov