Recruiting NCT06108492
A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-2005.
- Who it may be relevant to
- Registry conditions: Intermediate and High-risk Non-muscle Invasive Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug SHR-2005
In dose Escalation: Four dose levels are preset. The administration cycle included 6 times of induction perfusion period and 15 times of maintenance perfusion period. In indication Expansion: Indications will be selected to evaluate preliminary efficacy.
Primary outcome measures
- Incidence of dose limiting toxicities (DLTs) [Time frame: From Day 1 to Day 21]
- Maximum tolerated dose (MTD) [Time frame: From Day 1 to Day 21]
- Incidence and severity of adverse events (AEs) ([CTCAE] v5.0) [Time frame: From Day 1 to 90 days after last dose]
- RP2D（Recommended Phase 2 dose） [Time frame: From Day 1 to 90 days after last dose]
Secondary outcome measures (8)
- PK parameter: Tmax of SHR-2005 [Time frame: approximately 24 months]
- PK parameter: Cmax of SHR-2005 [Time frame: approximately 24 months]
- PK parameter: AUC0-∞ of SHR-2005 [Time frame: approximately 24 months]
- Immunogenicity of SHR-2005 [Time frame: approximately 24 months]
- Duration of response (DoR) [Time frame: approximately within 36 months]
- Disease control rate (DCR) [Time frame: approximately within 36 months]
- Progression-free survival (PFS) [Time frame: approximately within 36 months]
- Amount_recovered and Percent_recovered [Time frame: approximately 24 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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;
- History of serious cardiovascular and cerebrovascular diseases;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Zhongshan Hospital — Shanghai
Identifiers
NCT: NCT06108492 · SHR-2005-I-101