Phase 2 Brain Cancer Trial, Recruiting NCT07134153 Sponsor: Fudan University Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT07134153
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 aged 18 or older, of any gender
  • People who have HER2-expressing breast cancer that is advanced or has spread to other parts of the body
  • People whose cancer has spread to the membranes surrounding the brain and spinal cord (leptomeningeal metastasis)
  • People with active brain tumours must have at least one brain lesion that is large enough to be measured using specific imaging guidelines (confirm with trial site)
  • People whose liver, kidneys, and bone marrow are functioning at an adequate level
  • People who have not received radiotherapy, chemotherapy, targeted therapy, immunotherapy, hormone therapy, or surgery within the 2 weeks before joining (or within a specific timeframe based on their last treatment, whichever comes first)
  • People whose side effects from previous treatments have mostly cleared up, with only mild effects remaining

Who may not be able to join:

  • People diagnosed with another cancer in the past 5 years, unless it was a type that has been fully cured, such as certain skin cancers, early-stage cervical cancer, other non-invasive cancers, or papillary thyroid cancer
  • People with ongoing serious health conditions that are not well controlled, such as active infections, significant heart or blood vessel problems, severe ongoing diarrhoea, or mental health or social conditions that could make it difficult to follow the trial requirements
  • People who have a history of, or currently have, a type of lung inflammation (not caused by infection) that required steroid treatment, or where this condition cannot be ruled out during screening
  • People with other significant lung health problems
  • People who have used strong immune-suppressing medications or high-dose steroid tablets within the 2 weeks before the first dose (nasal sprays or inhaled steroids are generally not included in this restriction — confirm with trial site)
  • People with an active autoimmune disease, or a history of autoimmune disease that could come back
  • People with active uncontrolled infections currently needing intravenous (IV) antibiotics, antiviral, or antifungal treatment
  • People with a primary immune system disorder, known HIV, active hepatitis B, or active hepatitis C infection (people who have had hepatitis C may still be considered if a specific blood test confirms the virus is no longer active — confirm with trial site)
  • People whose scans show that the tumour is wrapped around or growing into major blood vessels, or where doctors consider there to be a high risk of serious bleeding
  • People who are pregnant or breastfeeding, or people who are able to have children but are unwilling or unable to use effective contraception during the trial
  • People with any other health condition that the trial doctors believe could affect how the trial runs or how results are understood

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
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: +8664175590

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
18 April 2025
Est. completion
30 August 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Phase I Stage Cohort A: Maximum Tolerated Dose (MTD); Phase I Stage Cohort B: Maximum serum concentration (Cmax); Phase I Stage Cohort B:Time to maximum serum concentration (Tmax); Phase I Stage Cohort B:Half-life (T1/2); Phase II Stage Cohorts A: LM-OS; Phase II Stage Cohorts B: LM-OS; Phase II Stage Cohorts C: LM-ORR; Phase II Stage Cohorts D: LM-ORR; Phase II Stage Cohorts E: LM-OS; Phase II Stage Cohorts F: LM-OS; Phase II Stage Cohorts G: LM-ORR; Phase II Stage Cohorts H: LM-ORR

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