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

• Status: Recruiting
• Trial end date: 2027-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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 high-risk non-muscle invasive bladder cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

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 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.