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Recruiting NCT06378242

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

Phase I / Phase II Interventional High-risk Non-muscle Invasive Bladder Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Disitamab Vedotin for injection.
Who it may be relevant to
Registry conditions: High-risk Non-muscle Invasive Bladder Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

This is a 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.

Interventions

  • Drug Disitamab Vedotin for injection
    Intravesical instiliations into the bladder

Primary outcome measures

  • Incidence of dose-limiting toxicity(DLT) (Phase I) [Time frame: Approximately 21 days]
  • Incidence of Adverse event (Phase I) [Time frame: Approximately 1 years]
  • Recommended Phase II Dose(RP2D) [Time frame: Approximately 21 days]
  • Maximum Tolerated Dosage(MTD) [Time frame: Approximately 21 days]
Secondary outcome measures (5)
  • Disease-free survival (DFS) rates [Time frame: Up to approximately 2 years]
  • Duration of response (DOR) [Time frame: Up to approximately 2 years]
  • Disitamab Vedotin anti-drug antibody (ADA) [Time frame: Up to approximately 2 years]
  • PK of enfortumab vedotin: Maximum concentration (Cmax) [Time frame: Approximately 1 years]
  • PK of enfortumab vedotin: Trough concentration (Ctrough) [Time frame: Approximately 1 year]

Eligibility criteria

Inclusion criteria

  • 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 6 centers
  • Sun Yat-sen Memorial Hospital,SunYat-sen University — Guangzhou
  • Tongji Hospital — Wuhan
  • Hunan Cancer hospital — Changsha
  • The first affiliated hospital with nanjing medical universtity — Nanjing
  • West China Hospital — Chengdu
  • Tianjin Medical University Second Hospital — Tianjin

Publications

  • 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. PMID 40661136

Identifiers

NCT: NCT06378242 · RC48-C029

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗