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

An Single-arm, Multicenter Phase I/II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2

This study is testing a new treatment for high-risk bladder cancer that shows a specific protein called HER2 to see if it is safe and effective for patients.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: RemeGen Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Disitamab
• Locations: 6 sites (Guangzhou, Guangdong and 5 other locations)
• Trial ID: NCT06378242 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with high-risk NMIBC that expresses HER2 and who are not suitable for radical surgery.

Not a fit: Patients with low-risk NMIBC or those who have resectable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for patients with high-risk NMIBC, potentially improving their outcomes.

How similar studies have performed: Other studies have explored HER2-targeted therapies in various cancers, showing promising results, but this specific approach in NMIBC is relatively novel.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong and 5 other locations

• Sun Yat-sen Memorial Hospital,SunYat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Tongji Hospital — Wuhan, Hubei, China (Not_yet_recruiting)
• Hunan Cancer hospital — Changsha, Hunan, China (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

Conditions High-risk Non-muscle Invasive Bladder Cancer; HER2-expression; High-risk non-muscle invasive bladder cancer; intravesical instiliations