A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.

Eligibility criteria

Qualifiers

Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;

≥18 years of age, either sex;

Previous pathological biopsy was diagnosed as intermediate or high-risk NMIBC ;

ECOG performance status of 0-1;

Disqualifiers

Received TURBT or other surgical treatment or radiotherapy for bladder lesions within 2 weeks before the first administration;

Patients who were receiving treatment in other clinical trials or less than 4 weeks from the end of the first administration in this study;

History of serious cardiovascular and cerebrovascular diseases;

Severe infection within 2 weeks prior to the first dose;

Trial design

Treatments tested in this trial

  • SHR-2005

Treatment groups

170 Participants
are divided into 1 treatment group