Phase 1 Bladder Cancer Trial, Recruiting NCT07217171 Sponsor: EvolveImmune United, Inc Condition: Bladder Cancer
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Phase 1 Bladder Cancer Trial, Recruiting

NCT07217171
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 locally advanced or metastatic cancer of one of these types: bladder cancer, squamous cell carcinoma of the lung, esophagus, skin, or an anogenital (anal or genital area) squamous cell carcinoma.
  • People whose cancer has continued to grow or spread during or after standard treatment for their cancer type.
  • People whose cancer can be measured on a CT scan or MRI.
  • People who are generally well enough to carry out light activity and care for themselves — this is measured using a standard medical scale called ECOG, where a score of 0 or 1 is required (confirm with trial site).
  • People with a life expectancy of at least 3 months.
  • People whose liver, kidneys, and other organs are functioning well enough, as shown by standard blood tests.
  • People who are able to provide a tumour tissue sample, either recently collected or stored from a previous biopsy.
  • People who agree to use contraception during the study and for 120 days after the last dose of the study drug — this does not apply to women who have gone through menopause or have had surgery that prevents pregnancy.

Who may not be able to join:

  • People whose cancer may be treatable with a targeted therapy that is known to be beneficial for their tumour type.
  • People who still have significant ongoing side effects from previous cancer treatments.
  • People who have cancer that has spread to the brain, unless that spread was previously treated and is now stable.
  • People who have had a severe or life-threatening reaction to the immune system from a previous cancer treatment.
  • People with a history of significant heart disease.
  • People with severe oesophageal (food pipe) conditions, such as a rupture or severe inflammation of the oesophagus.
  • People with active inflammation, erosion, or ulcers affecting the eyes (cornea or conjunctiva).
  • People with a history of cirrhosis (serious liver scarring) or significantly raised pressure in the liver's blood vessels.
  • People with an uncontrolled or serious active infection.
  • People who have been diagnosed with certain other cancers within the past 3 years (confirm with trial site for which cancers apply).
  • People who have had a blood clot in an artery, stroke, or mini-stroke (TIA) within the past 6 months.
  • People with active or uncontrolled HIV, hepatitis B, or hepatitis C infection.
  • People with an autoimmune condition or any other condition that requires ongoing medication to suppress the immune system.

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 28 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: EvolveImmune Study Team, EvolveImmune United, Inc

Phone: 12032086584

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
EvolveImmune United, Inc
Registry
ClinicalTrials.gov
Start date
13 November 2025
Est. completion
29 January 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence and Severity of Treatment Emergent Adverse Events (TEAEs); Number of patients with Dose Limiting Toxicities (DLTs); To determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) for EVOLVE104; To determine the recommended phase 2 dose (RP2D) of EVOLVE104

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: 28 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