Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer

NCT07646145 | Recruiting Phase 2

• 1 other identifier: KY2024066
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy and safety of intravenous administration of vedacitinib combined with intravesical instillation of mitomycin in treating patients with high-risk NMIBC with HER2 expression. The goal is to provide a new treatment option for NMIBC patients, reduce the risk of tumor recurrence, decrease the proportion of radical bladder surgery, and improve the quality of life of patients.

Conditions

Non-Muscle-Invasive Bladder Cancer (NMIBC)

Outcome Measures

Primary Outcomes (1)

• 1-year disease-free survival rate(1-year DFS rate)

  defined as the time from study treatment initiation to disease recurrence (confirmed by cystoscopic biopsy or imaging), disease progression (muscle invasion or distant metastasis), or death from any cause, estimated by the Kaplan-Meier method.

  At 12 months after the first study treatment.

Secondary Outcomes (3)

• Disease-free survival

  From drug combination to the first documented recurrence, disease progression, death from any cause, or last follow-up, assessed up to 12 months.

• Overall Survival（OS）

  From the date of first study treatment to the date of death from any cause or last known follow-up, whichever occurred first, assessed up to 12 months.

• Incidence and Severity of Treatment-emergent Adverse Events

  From the date of first study treatment until 30 days after the last dose of study treatment, assessed up to 12 months.

Study Arms (1)

Disitamab Vedotin Plus Intravesical Mitomycin C

EXPERIMENTAL

Participants will receive intravenous disitamab vedotin in combination with intravesical mitomycin C according to the protocol-defined treatment schedule.

Drug: Disitamab Vedotin; Drug: Mitomycin C (MMC)

Interventions

Disitamab Vedotin DRUG

Disitamab Vedotin injection: 2.0 mg/kg, every two weeks, treatment lasts for 8 to 12 cycles

Disitamab Vedotin Plus Intravesical Mitomycin C

Mitomycin C (MMC) DRUG

Mitomycin bladder intravesical instillation: 40mg per dose. Instill immediately after surgery, then once a week thereafter. The induction chemotherapy instillation lasts for 8 times. Subsequently, it is instilled once a month for a total of 10 months for maintenance chemotherapy.

Disitamab Vedotin Plus Intravesical Mitomycin C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shanxi Province Cancer Hospital: lead

Study Sites (1)

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

disitamab vedotin; Mitomycin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Xuebing Han

CONTACT

86+17861282270; hanxuebing808@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Urology Department

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 12, 2026
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)