Phase 1 Bladder Cancer Trial, Recruiting NCT06551233 Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Condition: Bladder Cancer
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Phase 1 Bladder Cancer Trial, Recruiting

NCT06551233
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:

  • You are 18 years of age or older
  • You have already tried at least one type of treatment delivered directly into the bladder (such as BCG or gemcitabine) and it did not work
  • You are unwilling or unable to have BCG bladder treatment
  • You have had a standard surgical procedure to remove bladder tumors (called TURBT) within the last 6 weeks, and no tumor was left behind after surgery
  • You are able to provide at least 5 tissue samples from that surgery, along with the related lab reports
  • Your bladder cancer has been confirmed by a lab to be a specific type (urothelial carcinoma, making up more than 50% of the tumor) and has not grown into the bladder muscle
  • Your cancer is classified as "high-risk" non-muscle-invasive bladder cancer
  • You are unwilling or unable to have your bladder surgically removed
  • A CT scan has confirmed your cancer has not spread to lymph nodes or other parts of the body
  • Your heart, bone marrow, liver, and kidneys are working well enough
  • You are generally active and able to care for yourself (confirm with trial site)
  • You are willing to use highly effective birth control during the study and for 180 days after your last dose; women must have a negative pregnancy blood test within 7 days before joining

Who may not be able to join:

  • You have a history of bladder cancer that has grown into the muscle or spread to other parts of the body
  • You have been diagnosed with another cancer in the past 3 years
  • You have received any other cancer treatment within 3 weeks before starting this trial
  • You have had bladder surgery or radiation therapy within 2 weeks before starting this trial
  • You have had a serious allergic reaction to the study drug (9MW2821) or similar medications
  • You still have significant side effects from a previous cancer treatment that have not improved sufficiently
  • You have an active infection requiring treatment within the 7 days before starting the trial
  • You have had a serious heart condition within the past 6 months
  • You have had a bone marrow or organ transplant from another person
  • You have a history of autoimmune disease (a condition where the immune system attacks the body)
  • You have certain untreated or active viral infections, including hepatitis B, hepatitis C, or HIV (confirm with trial site for specific test details)
  • You have previously been treated with drugs that target a protein called Nectin-4, or with a similar type of drug called an MMAE-conjugated ADC (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 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

Phone: 8613605171690

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
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Registry
ClinicalTrials.gov
Start date
22 April 2024
Est. completion
30 November 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Safety and tolerability; RP2D and MTD

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