Phase 1 Bladder Cancer Trial, Recruiting NCT06173349 Sponsor: University of California, Davis Condition: Bladder Cancer
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Phase 1 Bladder Cancer Trial, Recruiting

NCT06173349
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 non-muscle-invasive bladder cancer (a type of bladder cancer that has not grown deep into the bladder wall), confirmed by a surgical procedure to remove bladder tumours, done within 3 months of joining the trial
  • People whose bladder cancer has not responded to BCG treatment (a common bladder cancer therapy), or who could not tolerate BCG treatment, meeting specific criteria around how and when the cancer returned or persisted after BCG
  • People whose doctor has recommended bladder removal surgery as the next standard treatment option, but who have declined it or are unable to have it
  • People aged 18 or older at the time of giving consent
  • People with a general health and activity level rated as 0, 1, or 2 on a standard medical scale (meaning fully active to capable of light activity, confirm with trial site)
  • People expected to live for more than 24 months
  • People who are not currently receiving radiotherapy, chemotherapy, other immunotherapy, or BCG or other bladder treatments within the past 4 weeks
  • People who do not have any other cancer treatments or surgery planned before the first assessment of how well the trial treatment is working
  • People who have recovered sufficiently from side effects of previous treatments, as judged by the trial doctor
  • People with blood test results meeting minimum levels for white blood cells, platelets, haemoglobin, kidney function, and liver function (specific values to be confirmed with the trial site)
  • People with adequate lung function based on clinical assessment, with no signs of serious breathing problems
  • People who are able to use reliable contraception throughout the trial and for 3 months after the last treatment, or who have had a permanent sterilisation procedure (applies to people who could become pregnant or father a child)
  • People who are able to understand and willing to sign a consent form
  • People who are able and willing to attend scheduled trial visits and follow the trial requirements

Who may not be able to join:

  • People who have cancer in the upper part of the urinary tract (kidneys or ureters)
  • People currently taking part in another clinical trial involving an experimental treatment
  • People whose cancer has spread to nearby lymph nodes or other parts of the body
  • People with serious heart conditions, including severe heart failure, uncontrollable irregular heartbeats, or any history of a dangerous heart rhythm problem
  • People who have had a heart attack, severe chest pain, or symptoms of heart failure within the 6 months before joining the trial
  • People with a bleeding disorder that cannot be controlled (such as certain clotting factor deficiencies or Von Willebrand Disease)
  • People taking certain blood-thinning or clotting-affecting medications, such as warfarin, heparin, or similar drugs (low-dose aspirin of 81 mg daily is allowed; some anti-inflammatory medications may be allowed if stopped the day before treatment — confirm with trial site)
  • People with a history of uncontrolled disease affecting the brain or nervous system
  • People with an active serious infection currently requiring intravenous antibiotics
  • People who are pregnant or breastfeeding
  • People who have been diagnosed with another cancer within the past 3 years, with some exceptions such as certain low-risk skin cancers, non-invasive cervical cancer, or some other cancers considered low-risk during the trial period (confirm with trial site)
  • People who are unable to understand or give informed consent for any reason
  • People with any other condition that, in the trial doctor's judgement, could affect their safety or ability to participate

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 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: Mamta Parikh, University of California, Davis

Phone: 916-382-6970

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
Registry
ClinicalTrials.gov
Start date
22 November 2023
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Treatment related adverse events

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