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
NCT ID: NCT06378242
Last Updated: 2024-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2024-06-14
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Disitamab Vedotin Intravesical instiliations :Dose escalation cohort
Participants will receive Disitamab Vedotin for injection Intravesical instiliations into the bladder for 1 hour, D1, once a week.
Disitamab Vedotin for injection
Intravesical instiliations into the bladder
Interventions
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Disitamab Vedotin for injection
Intravesical instiliations into the bladder
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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RemeGen Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Sun Yat-sen Memorial Hospital,SunYat-sen University
Guangzhou, Guangdong, China
Tongji Hospital
Wuhan, Hubei, China
Hunan Cancer hospital
Changsha, Hunan, 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
Countries
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Central Contacts
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Facility Contacts
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Tianxin Lin, Ph.D
Role: primary
Shaogang Wang, M.D
Role: primary
Shusuan Jiang, M.D
Role: primary
qiang Lv, M.D
Role: primary
Peng Zhang, M.D
Role: primary
Hailong Hu, M.D
Role: primary
References
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Chen X, Huang M, Chen Z, Zhang C, Pan B, Liu C, Xu W, Fang J, Huang J, Lin T. Intravesical Disitamab Vedotin (RC48) for HER2-Expressing High-Risk Non-Muscle-Invasive Bladder Cancer: A Single-Arm, Dose-Escalation Phase I Trial Study. MedComm (2020). 2025 Jul 13;6(7):e70288. doi: 10.1002/mco2.70288. eCollection 2025 Jul.
Other Identifiers
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RC48-C029
Identifier Type: -
Identifier Source: org_study_id
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