Clinical trial · Interventional
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
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
NCT06378242CI-TRIAL-00078759recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-risk Non-muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Disitamab Vedotin for injection | Drug | Disitamab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Disitamab Vedotin Intravesical instiliations :Dose escalation cohort
- description
- Participants will receive Disitamab Vedotin for injection Intravesical instiliations into the bladder for 1 hour, D1, once a week.
- interventionNames
- Drug: Disitamab Vedotin for injection
Primary outcomes (4)
- measure
- Incidence of dose-limiting toxicity(DLT) (Phase I)
- timeFrame
- Approximately 21 days
- measure
- Incidence of Adverse event (Phase I)
- timeFrame
- Approximately 1 years
- description
- According to the NCI CTCAE V5.0, to evaluate safety including adverse event rate and adverse event grade
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDChen 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. PMID 40661136