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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fudan University Zhongshan Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Shouwei Zhao
• Email: shouwei.zhao@hengrui.com
• Phone: 0518-82342973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• HS-10566 treatment in high-risk non-muscle-invasive bladder cancer where surgery isn’t an option

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• Evaluating a new treatment for high-risk non-muscle-invasive bladder cancer

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• Evaluating a new treatment for high-risk bladder cancer that expresses HER2

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.