New drug duo aims to stop bladder cancer from coming back
NCT ID NCT07646145
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial is testing a combination of two drugs—disitamab vedotin given through a vein and mitomycin C placed directly into the bladder—in 30 people with a specific type of non-muscle-invasive bladder cancer that has a protein called HER2. The goal is to see if this treatment can reduce the risk of the cancer returning and help patients avoid more aggressive surgery to remove the bladder.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Disitamab vedotin (an antibody-drug conjugate) and mitomycin C (a chemotherapy drug given directly into the bladder)
- What this could lead to
- If this works, it could offer a new treatment option that lowers the chance of bladder cancer coming back and helps patients avoid needing their bladder removed.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. The combination of drugs may cause side effects, and it is not yet known if it works better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Voluntary participation, signing a written informed consent form; * The age on the date of signing the informed consent form should be no less than 18 years old, regardless of gender; * The subjects have completed the standard TURBT procedure before signing the informed consent form, and no obvious residual tumor lesions were found in the surgical field; * The postoperative pathology clearly diagnosed as non-muscle-invasive bladder cancer, and the main tissue component was more than 50% urothelial carcinoma (transitional cell carcinoma); * The subjects were classified into the intermediate-risk or high-risk group according to the risk classification for NMIBC; * Tumor tissue samples for TURBT must be provided, along with the required relevant pathological reports. Fresh surgical tissues or pathological slides can be sent for examination as well; * The patients were intolerant to BCG or did not accept the BCG infusion treatment plan; * Before treatment, HER2 detection was conducted on the resection specimens in the laboratory: The IHC results confirmed HER2 expression (defined as: IHC 1+, 2+ or 3+); * Clinical non-metastatic bladder cancer (N0, M0) was determined by abdominal computed tomography (CT). Exclusion Criteria: * History of muscle-invasive bladder cancer or metastatic bladder cancer before treatment;History of muscle-invasive bladder cancer or metastatic bladder cancer before treatment; * Imaging results within 3 months before treatment indicated lymph node or other site/organ metastasis; * Imaging results within 3 months before treatment indicated the presence of other urinary system tumors; * Received other systemic anti-cancer treatments within 3 weeks before treatment, including chemotherapy, biological therapy, immunotherapy, targeted therapy, endocrine therapy, and/or investigational drug therapy; * Received bladder radiotherapy for urothelial carcinoma before treatment; * Known to have anaphylaxis or delayed allergic reaction to certain components of vedacitinib or similar drugs; * Within the 3 days prior to the first infusion, the following conditions had not yet been alleviated to CTCAE grade 1:Uncontrolled acute or chronic infections, such as pneumonia, biliary tract infections;Hepatitis B and Hepatitis C infections; dyspnea;Acute or chronic kidney injury; nephrotic syndrome; bladder perforation; urinary tract obstruction; * NYHA rating of 3 or 4; * Symptoms and signs related to cardiovascular diseases: including myocardial infarction, congestive heart failure, arrhythmia, etc.; * Known cerebrovascular accidents; * History of autoimmune diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, hemolytic anemia, rheumatoid arthritis, etc.); * Known positive HIV serology, Hepatitis C infection and/or Hepatitis B (HepBsAg or core antibody positive and responding after antiviral treatment for Hepatitis B, except for these patients: these patients are allowed to participate in this study; Note: Patients with negative HepBsAg at screening)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanxi Provincial Cancer Hospital
RECRUITINGTaiyuan, Shanxi, 030000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can heated saline during bladder surgery stop tumors from coming back?
- Can a bladder rinse before surgery keep bladder cancer at bay?
- Can a home care plan ease bladder cancer treatment side effects?
- Can a new drug help keep bladder cancer at bay?
- Can heated chemotherapy beat bladder cancer without surgery?
- Could a simple urine test spare bladder cancer patients from chemotherapy?