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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRemeGen Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Absence of resectable disease(Ta and/or T1 disease) after transurethral resection (TURBT) procedures (residual CIS acceptable;

Disqualifiers

1. Invasive bladder cancer (T2 and above) and / or with regional lymph node and distant metastasis.

Trial design

Treatments tested in this trial

  • Disitamab Vedotin for injection

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators