NCT06108492RecruitingPhase 1
A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
Source: ClinicalTrials.gov · Last updated 3 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 25 Oct 2023
- Start date
- 28 Nov 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Diseases
- Bladder cancer
- NCT number
- NCT06108492
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 170
- From 28 Nov 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of serious cardiovascular and cerebrovascular diseases;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.