Phase 1 Brain Cancer Trial, Recruiting NCT05879367 Sponsor: Orbus Therapeutics, Inc. Condition: Brain Cancer
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Phase 1 Brain Cancer Trial, Recruiting

NCT05879367
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 who have been diagnosed with a specific type of brain tumour — either a grade 4 glioblastoma (GBM) with a particular genetic profile (IDH-wildtype), or a grade 3 astrocytoma with certain genetic markers — classified according to the 2021 World Health Organization system.
  • People who have already completed a standard course of radiation therapy to the brain.
  • For GBM patients: people who received at least 80% of their planned daily doses of the chemotherapy drug temozolomide (TMZ) during radiation treatment. For astrocytoma patients: people who completed at least 2 but no more than 4 cycles of TMZ after radiation.
  • People whose blood counts and organ function (including kidneys, liver, and blood) are within acceptable ranges based on lab tests.
  • People who are willing to either avoid sexual intercourse or use an approved form of contraception during the trial.
  • People taking steroid medications, provided the dose is stable or being reduced at the time of joining.

Who may not be able to join:

  • People with a recent history of another cancer that has come back or spread to other parts of the body, which could make it harder to assess how the brain tumour is responding to treatment.
  • People who have previously received any cancer chemotherapy other than temozolomide (as described above for each tumour type).
  • People who have previously used a device called Optune (a wearable tumour treatment device).
  • People who have an active infection or another serious ongoing medical condition.
  • People whose seizures are not well controlled.
  • People who have had a significant heart condition within the 6 months before joining the trial.
  • People whose diabetes is not well controlled.
  • People who have taken part in another clinical trial or used an experimental treatment within 30 days before joining this trial.

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 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: Howard Colman, MD, PhD, Huntsman Cancer Institute/ University of Utah

Phone: 6506569424

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
Orbus Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
24 July 2023
Est. completion
30 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Assessment of Dose Limiting Toxicities; Incidence of TEAEs All Grades; Incidence of TEAEs Grade 3+; Incidence of TEAEs Serious; Incidence of TEAEs Leading to Discontinuation; Vital Signs (Heart and Respiratory Rate); Vital Signs (Blood Pressure); Incidence of Treatment-Emergent Abnormalities in Clinical Laboratory Tests

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