Phase 2 Bladder Cancer Trial, Recruiting NCT07283835 Sponsor: Lepu Biopharma Co., Ltd. Condition: Bladder Cancer
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Phase 2 Bladder Cancer Trial, Recruiting

NCT07283835
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:

  • You must be 18 years of age or older at the time you sign the consent form
  • You must have been diagnosed with a specific type of bladder cancer (non-muscle-invasive bladder cancer with carcinoma in situ) that has stopped responding to a common bladder cancer treatment called BCG, with or without other early-stage bladder tumors present
  • You must be generally well enough to carry out daily activities, ranging from fully active to capable of limited self-care (confirm with trial site)
  • Any visible tumors must have been removed or treated as much as safely possible before the study treatment begins
  • Your kidneys, liver, and other organs must be working well enough to safely participate (confirm with trial site)
  • You must be willing to attend all required check-ups, scans, bladder examinations, biopsies, and other procedures throughout the entire study
  • You must either be unable to have bladder removal surgery, or have chosen not to have it, as assessed by your doctor

Who may not be able to join:

  • You have had, or currently have, bladder cancer that has grown deeper into the bladder muscle or has spread to nearby tissues or other parts of the body
  • You have had a related type of cancer in your kidneys, urinary tract, ureter, or certain parts of the urethra within the past 24 months
  • You have previously received systemic (whole-body) anti-cancer treatments or experimental cancer therapies
  • You have had radiation therapy or surgery for bladder cancer other than standard tumor removal procedures (note: prior checkpoint inhibitor therapy may be an exception — confirm with trial site)
  • You have experienced a heart attack, severe chest pain, stroke, blood clot in the lungs, uncontrolled high blood pressure, or uncontrolled heart failure within the past 6 months
  • You are unable to tolerate the study-related biopsies, the method of delivering the study treatment into the bladder, or holding the treatment in your bladder for one hour

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 27 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

Principal Investigator: Dinɡwei Ye, M.D., Fudan University

Phone: 86-21-61637960

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
Lepu Biopharma Co., Ltd.
Registry
ClinicalTrials.gov
Start date
4 December 2025
Est. completion
31 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Complete response rate at any time in BCG-unresponsive high-risk NMIBC with or without Ta/T1 papillary tumors including CIS

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: 27 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