Phase 2 Brain Cancer Trial, Recruiting NCT07363057 Sponsor: GI Innovation, Inc. Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT07363057
Recruiting Phase 2 🇦🇺 Australian site

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 to 80 years old at the time of signing the consent form.
  • People whose general health is not severely compromised — meaning no life-threatening illness or disability, as assessed by the trial doctor.
  • People with a history of cancer may be considered if they have been free of the disease for 2 or more years, OR if diagnosed within the last 2 years, their cancer was treated with the aim of curing it, they have been in remission for at least 12 months, they are not receiving active cancer treatment (except maintenance therapies such as hormone therapy or bone-strengthening medication), and their cancer treatment did not include immunotherapy.
  • Women who could become pregnant must agree to use a highly effective form of contraception starting 14 days before the second study visit and continuing until 180 days after their last dose of the study medication.
  • Men who are fertile must agree to use an acceptable form of contraception starting 14 days before the second study visit and continuing until 90 days after their last dose of the study medication.

Who may not be able to join:

  • People with serious, poorly controlled chronic conditions — such as advanced heart disease, kidney failure requiring dialysis or transplant, uncontrolled diabetes, active or recent cancer (within 2 years), severe COPD, terminal cancer, or a history of a life-threatening infection such as meningitis.
  • People who rely on a walker or wheelchair to move around, or who have serious difficulty performing everyday tasks independently, or who are unable to complete the physical tests required by the trial — as assessed by the trial doctor. (Note: people who have had an amputation may still be considered if they are able to walk without a walker or wheelchair.)
  • People who have had major surgery in the past 6 months, or who have major surgery planned during the study period, including joint replacement surgery.
  • People with a history of substance abuse or dependency, or recreational intravenous drug use in the past 5 years (based on self-reporting).
  • Women who are pregnant, planning to become pregnant, or currently breastfeeding during the study period. (Note: women going through perimenopause or the menopause transition are not excluded on this basis.)

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 21 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

Phone: +82-2-404-2003

Australian sites

Novatrials, Charlestown, New South Wales
+61 02-4089-3744
Southern Oncology Clinical Research Unit, Adelaide, South Australia
+61 491-679-039

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
GI Innovation, Inc.
Registry
ClinicalTrials.gov
Start date
1 January 2026
Est. completion
1 May 2026

Where this trial is recruiting

🇦🇺 Australia

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change in Baseline values in immune response (NK cells) before and after GI-102 and GIB-7 combination treatment; Change in Baseline values in immune response (CD8+ T cells) before and after GI-102 and GIB-7 combination treatment; Frequency of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) of the combination of GI-102 and GIB-7 by severity; Number of participants with various adverse events and abnormal lab data

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: 21 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