Treatment of intermediate and high-risk non-muscle invasive bladder cancer with SHR-2005

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 testing a new treatment called SHR-2005 for people with intermediate and high-risk non-muscle invasive bladder cancer to see if it is safe and effective.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06108492 on ClinicalTrials.gov

What this trial studies

This Phase I clinical trial evaluates the safety, tolerability, pharmacokinetics, and efficacy of SHR-2005 through intravesical instillation in patients diagnosed with intermediate and high-risk non-muscle invasive bladder cancer. The study is open-label and multicenter, allowing for a diverse patient population. Participants will receive SHR-2005 and will be monitored for any adverse effects and treatment outcomes. The trial aims to gather preliminary data on the drug's effectiveness and safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of intermediate or high-risk non-muscle invasive bladder cancer.

Not a fit: Patients who have undergone recent surgical treatments or have serious underlying health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with challenging forms of bladder cancer.

How similar studies have performed: While this approach is being explored in this trial, similar studies have shown promise in the treatment of bladder cancer, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
2. ≥18 years of age, either sex;
3. Previous pathological biopsy was diagnosed as intermediate or high-risk NMIBC ;
4. ECOG performance status of 0-1;
5. Life expectancy ≥ 2 years;
6. Adequate bone marrow and organ function.

Exclusion Criteria:

1. Received TURBT or other surgical treatment or radiotherapy for bladder lesions within 2 weeks before the first administration;
2. Patients who were receiving treatment in other clinical trials or less than 4 weeks from the end of the first administration in this study;
3. History of serious cardiovascular and cerebrovascular diseases;
4. Severe infection within 2 weeks prior to the first dose;
5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0;
6. Oversize surgery or severe trauma within 4 weeks before the first use of research drugs;
7. Previously received any TNFR agonist antibody therapy, such as OX40, CD137, CD27, CD357 antibodies.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Zhongshan Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Shouwei Zhao

Conditions: Intermediate and High-risk Non-muscle Invasive Bladder Cancer