Early Phase 1 Brain Cancer Trial, Recruiting NCT07538128 Sponsor: Huashan Hospital Condition: Brain Cancer
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Early Phase 1 Brain Cancer Trial, Recruiting

NCT07538128
Recruiting Early 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:

  • You are over 18 years old (male or female)
  • Your doctors expect you to live for at least 12 weeks
  • You are able to carry out most daily activities and care for yourself (confirm with trial site regarding the specific activity score required)
  • You have been diagnosed with glioblastoma (a type of brain tumour) that has come back for the first time after previous surgery, chemotherapy, and/or radiotherapy
  • Your brain scan (MRI) shows one tumour area that lights up with contrast dye, measuring between 1 and 4 cm across
  • Your blood tests show your blood, liver, kidneys, and clotting function are healthy enough for a biopsy and a small device to be placed in your brain
  • Any side effects from your previous cancer treatments have mostly cleared up, with only very mild effects remaining (confirm with trial site)
  • If you are able to have children, you agree to use effective contraception throughout the trial and for at least 6 months after your last dose

Who may not be able to join:

  • You have or have had another type of cancer (separate from the brain tumour)
  • You have a known allergy to the study drug or its ingredients, or have had a severe unexplained allergic reaction in the past
  • You cannot have a gadolinium-enhanced MRI scan — for example, because you have a pacemaker, an infusion pump, or an allergy to MRI contrast dye
  • Your tumour affects the brainstem, cerebellum, or spinal cord, or has spread to the lining of the brain or spinal cord
  • Your MRI shows the tumour reaches the wall of the fluid-filled spaces in your brain (ventricles), or surgery has caused the tumour cavity to connect with those spaces
  • The planned path for placing the brain device would pass through the fluid-filled spaces in your brain (confirm with trial site)
  • You currently have an active infection requiring antibiotics given through a drip, or you have an unexplained fever of 37.5°C or above
  • You have an uncontrolled ongoing health condition, including poorly controlled diabetes, certain heart or blood vessel problems, breathing difficulties, thyroid problems, or a stroke within the last 6 months (confirm with trial site for full details)
  • You have an active autoimmune disease (where the immune system attacks the body) or a history of one, such as rheumatoid arthritis, lupus, Crohn's disease, or similar conditions
  • You are planning to receive a live vaccine at any point during screening or treatment
  • You have any other condition that your doctor feels makes it unsafe for you to receive the study drug (confirm with trial site)

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 26 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Zhifeng Shi, Dr., Huashan Hospital

Phone: +86 13661519863

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
Early Phase 1
Sponsor
Huashan Hospital
Registry
ClinicalTrials.gov
Start date
9 January 2025
Est. completion
27 November 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs); 1-year survival rate

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: 26 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