Phase 2 Brain Cancer Trial, Recruiting NCT07416188 Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT07416188
Recruiting Phase 2

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:

  • Adults aged 18 or older
  • People who have been diagnosed by a specialist brain pathologist with glioblastoma (a type of brain tumour) that has come back after previous treatment, and whose tumour has a specific characteristic called IDH-wildtype
  • People whose general health and ability to function is above a certain level, as measured by a standard scale used by doctors (confirm with trial site)
  • People willing to use an effective form of birth control (such as hormonal, barrier, surgical methods, or abstinence) during the study and for 6 months after the last dose of the study drug — and who will inform their treating doctor immediately if pregnancy occurs or is suspected
  • People willing to undergo a brain surgery procedure (craniotomy) for a biopsy and/or removal of tumour tissue, where full removal of the tumour is not expected to be possible
  • People willing to formally appoint someone to make decisions on their behalf if needed (a durable power of attorney)
  • People who are able to give informed consent themselves, or who have a legally authorised representative who can do so on their behalf

Who may not be able to join:

  • People who are pregnant or currently breastfeeding
  • People with serious ongoing health conditions that cannot be reasonably managed and that could affect their ability to tolerate the study drug — for example, poorly controlled kidney disease or heart failure (as judged by the investigating doctor)
  • People whose personal or social circumstances would make it difficult to follow the study requirements, such as chronic homelessness
  • People who have received chemotherapy or certain other cancer-fighting treatments too recently before joining the study (generally within 4–6 weeks, depending on the type of treatment)
  • People who have been diagnosed with, or are being actively treated for, another cancer within the past year
  • People who are unable to have an MRI scan of the brain
  • People who have an active autoimmune disease (where the immune system attacks the body) that has required whole-body treatment within the past 2 years
  • People with certain heart conditions, including: two or more heart attacks; two or more procedures to open blocked heart arteries; certain abnormal heart enzyme levels on blood tests; or a heart pumping function below 45% on an ultrasound of the heart
  • People with persistently very low potassium levels in the blood
  • People with a known history of HIV, or who test positive for HIV at screening
  • People with an active Hepatitis B or Hepatitis C infection at the time of screening
  • People with an active infection that is currently being treated with antibiotics, antiviral, or antifungal medicines within 7 days before starting the study drug
  • People who have previously received certain types of immune cell therapies (autologous or allogeneic T cells)
  • People who have received a solid organ or tissue transplant

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 27 July 2026
Phase 2: approximately ~30% 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: Sadhana Jackson, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

Phone: (301) 594-7037

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 2
Registry
ClinicalTrials.gov
Start date
15 July 2026
Est. completion
31 December 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Partial response (>=50% disease reduction) or complete response (100% disease reduction) based on RANO 2.0 criteria

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: 27 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