Phase 2 Brain Cancer Trial, Recruiting NCT06011109 Sponsor: Aveta Biomics, Inc. Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT06011109
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:

  • People who have a confirmed diagnosis of a high-grade brain tumour (grade III or IV glioma, including glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, or H3K27M mutant glioma) that has continued to grow or returned after treatment with bevacizumab.
  • People who have previously been treated with radiation therapy and the chemotherapy drug temozolomide — any number of prior treatments for tumour progression are acceptable.
  • People who finished their combined chemotherapy and radiation treatment at least 3 months ago, or whose scans or biopsy results show the tumour is growing again.
  • People aged 19 years or older.
  • People whose side effects from previous treatments have mostly resolved to a mild level or better.
  • People who are reasonably well and able to carry out some daily activities (confirmed with trial site using a standard health performance scale).
  • People whose blood counts are at acceptable levels, showing the bone marrow is producing enough blood cells.
  • People whose kidneys and liver are functioning at acceptable levels, based on blood test results.
  • People who are willing to give written consent after being fully informed about the trial, its risks, and alternatives.
  • Women who could become pregnant must not be pregnant or breastfeeding, and must agree to use an effective barrier method of contraception during the trial and for up to 6 months after treatment ends.
  • Women who could become pregnant must have a negative pregnancy test within 7 days of starting the trial (women aged 55 or older with no menstrual period for two years, or women of any age who have had their uterus and/or both ovaries surgically removed, are not required to meet this criterion).

Who may not be able to join:

  • People with a serious illness, medical condition, or organ problem that, in the doctor's opinion, could affect their safety or interfere with how the study drug works.
  • People who have received immunotherapy, chemotherapy, radiation, or another experimental treatment too recently before the first dose — the required waiting period depends on the specific treatment (for example, 6 weeks for lomustine or 4 weeks for temozolomide).
  • People who are currently pregnant or breastfeeding.
  • People who have had severe allergic reactions to bevacizumab that could not be controlled.
  • People with significant heart or blood vessel problems, including: blood pressure that remains too high despite medication, a stroke within the past 6 months, or a heart attack or severe chest pain within the past 6 months.
  • People with a history of abnormal bleeding disorders or serious bleeding events within the past 4 weeks (note: people on a stable dose of blood-thinning medication for at least 2 weeks may still be considered eligible — confirm with trial site).
  • People with an active wound, a wound that is not healing, an active ulcer, or an untreated bone fracture within the past 2 months.
  • People with a history of a hole or tear in the digestive tract, an abdominal abscess, or an abnormal passage (fistula) in the abdomen within the past 6 months.
  • People who have had a major surgery, open biopsy, or serious physical injury within the past 28 days.
  • People with another significant medical condition, abnormal lab results, or a mental health condition that, in the doctor's opinion, could affect their ability to follow the trial requirements or give informed consent.

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 12 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: Nicole Shonka, MD, University of Nebraska

Phone: 402-559-3881

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
Sponsor
Aveta Biomics, Inc.
Registry
ClinicalTrials.gov
Start date
13 December 2023
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Progression-free Survival; Overall Survival

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: 12 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