Evaluating a new treatment for high-risk bladder cancer that expresses HER2

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is designed to assess the safety, efficacy, and pharmacokinetics of Disitamab Vedotin administered through intravesical instillations in patients diagnosed with high-risk non-muscle invasive bladder cancer (NMIBC) that express HER2. It is a single-arm, multicenter study that includes both Phase 1 and Phase 2 evaluations. Participants will receive the treatment while being monitored for safety and effectiveness, with a focus on how the drug is processed in the body. The study aims to provide insights into a potential new therapeutic option for this specific cancer population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntary consent to participate in the study and signed the informed consent form.
2. Male or female, age 18-75 years (including both).
3. Histologic confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC), and the risk group met the high-risk (including very high-risk) group.

   Note: High-risk NMIBC is a high-grade / G3 tumor meeting any of the following:

   a.Carcinoma in situ (CIS) b. T1 stage c. diameter\>3cm d.Multiple tumors, or recurrent tumors.
4. Absence of resectable disease（Ta and/or T1 disease） after transurethral resection (TURBT) procedures (residual CIS acceptable;
5. The urologist assessed that radical surgery for bladder cancer was not suitable or the subject refused radical surgery for bladder cancer.
6. Tumor tissue samples were detected by immunohistochemistry (IHC) to satisfy HER2 expression of 1+, 2+ or 3+.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
8. Adequate heart, bone marrow, liver, kidney and coagulation function

Exclusion Criteria:

* 1\. Invasive bladder cancer (T2 and above) and / or with regional lymph node and distant metastasis.

  2\. Combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis).

  3\. Any other antitumor therapy received within 4 weeks before study administration, .

  4 Subjects plan to undergo major surgery during the study or within 4 weeks before the first dose.

  5, Known allergic to DV and its components or to any excipients.

Where it's running

• Sun Yat-sen Memorial Hospital,SunYat-sen University
  Guangzhou, Guangdong, China Recruiting
• Hunan Cancer hospital
  Changsha, Hunan, China Recruiting
• Tongji Hospital
  Wuhan, Hubei, China Not yet recruiting
• The first affiliated hospital with nanjing medical universtity
  Nanjing, Jiangsu, China Not yet recruiting
• West China Hospital
  Chengdu, Sichuan, China Not yet recruiting
• Tianjin Medical University Second Hospital
  Tianjin, Tianjin Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Hong Luo
• Email: hong.luo@remegen.com
• Phone: +8610-58075763

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NMIBC sample collection to test cancer monitoring biomarkers

  This study tests a blood, urine, and tumor tissue collection approach in people with high-risk non-muscle invasive bladder cancer to see if a molecular test can detect residual disease and monitor recurrence.

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• Disitamab Vedotin Plus Radiotherapy for HER2-Expressing Upper Tract Urothelial Carcinoma After Surgery

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• JL19001 Injection for High-Risk NMIBC (alone or with BCG)

  This early-stage study tests different doses of JL19001 injections to see if they are safe and tolerable in adults with high-risk non-muscle invasive bladder cancer.

  Recruiting Phase 1 Jecho Biopharmaceuticals Co., Ltd. · Chengdu, Sichuan · NCT07483970

• Disitamab vedotin plus SOX versus SOX alone as adjuvant treatment for HER2-moderate/high stage III gastric cancer after surgery

  This trial will test whether adding disitamab vedotin to standard SOX chemotherapy helps people with HER2-moderate/high stage III gastric cancer after surgery stay cancer-free longer or live longer.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07474324

• HS-10566 treatment in high-risk non-muscle-invasive bladder cancer where surgery isn’t an option

  This study tests HS-10566 to see if it can help people with high-risk NMIBC who can’t or won’t have radical cystectomy.

  Recruiting at 2 sites Phase 1/2 Jiangsu Hansoh Pharmaceutical Co., Ltd. · Beijing and 1 other locations · NCT07468851

• Disitamab vedotin plus bevacizumab for HER2-low metastatic breast cancer after T‑DxD failure

  This study will try disitamab vedotin combined with bevacizumab in adults with HER2‑low metastatic breast cancer whose disease progressed after trastuzumab deruxtecan.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07446452

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.