Tests SHR-2005 bladder instillation in intermediate and high-risk bladder cancer
Tests SHR-2005, given into the bladder, in adults with early bladder cancer.
Plain-language title generated from the registry record
Registry title: A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1
Where in China
- Fudan University Zhongshan HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Trial code
- NCT06108492
- Record updated
- 3 December 2024
- Original description
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.Read full original descriptionShow less
A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
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.
Inclusion: 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; Life expectancy ≥ 2 years; Adequate bone marrow and organ function.
Exclusion: 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; Severe infection within 2 weeks prior to the first dose; Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0; Oversize surgery or severe trauma within 4 weeks before the first use of research drugs; Previously received any TNFR agonist antibody therapy, such as OX40, CD137, CD27, CD357 antibodies; History of serious cardiovascular and cerebrovascular diseases.