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 groupSponsors and collaborators
Source ClinicalTrials.gov