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

Recruiting now · Phase 1/Phase 2

Conditions studied: High-risk Non-muscle Invasive Bladder Cancer

In brief

The purpose of this study is 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

Key facts

Study ID

NCT06378242

Run by

RemeGen Co., Ltd.

People needed

24

Starts

2024-06-14

Expected to finish

2029-12-31

Last updated by the study team

2024-07-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntary consent to participate in the study and signed the informed consent form.
• Male or female, age 18-75 years (including both).
• 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.
• Absence of resectable disease（Ta and/or T1 disease） after transurethral resection (TURBT) procedures (residual CIS acceptable;
• The urologist assessed that radical surgery for bladder cancer was not suitable or the subject refused radical surgery for bladder cancer.
• Tumor tissue samples were detected by immunohistochemistry (IHC) to satisfy HER2 expression of 1+, 2+ or 3+.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Adequate heart, bone marrow, liver, kidney and coagulation function

You may not qualify if…

• 1. Invasive bladder cancer (T2 and above) and / or with regional lymph node and distant metastasis.
• Combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis).
• 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 is running

• Sun Yat-sen Memorial Hospital,SunYat-sen University — Guangzhou, Guangdong, China (enrolling)
• Hunan Cancer hospital — Changsha, Hunan, China (enrolling)
• Tongji Hospital — Wuhan, Hubei, China
• The first affiliated hospital with nanjing medical universtity — Nanjing, Jiangsu, China
• West China Hospital — Chengdu, Sichuan, China
• Tianjin Medical University Second Hospital — Tianjin, Tianjin Municipality, China

Full record on ClinicalTrials.gov

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