Clinical trial 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)
Official title: A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Intermediate and High-risk Non-muscle Invasive Bladder Cancer
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-31
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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 intermediate and high-risk non-muscle invasive bladder cancer.


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.

Primary outcomes:
measure: Incidence of dose limiting toxicities (DLTs)
timeFrame: From Day 1 to Day 21
measure: Maximum tolerated dose (MTD)
timeFrame: From Day 1 to Day 21
measure: Incidence and severity of adverse events (AEs) ([CTCAE] v5.0)
timeFrame: From Day 1 to 90 days after last dose
measure: RP2D（Recommended Phase 2 dose）
timeFrame: From Day 1 to 90 days after last dose
Secondary outcomes:
measure: PK parameter: Tmax of SHR-2005
timeFrame: approximately 24 months
measure: PK parameter: Cmax of SHR-2005
timeFrame: approximately 24 months
measure: PK parameter: AUC0-∞ of SHR-2005
timeFrame: approximately 24 months
measure: Immunogenicity of SHR-2005
timeFrame: approximately 24 months
measure: Duration of response (DoR)
timeFrame: approximately within 36 months
measure: Disease control rate (DCR)
timeFrame: approximately within 36 months
measure: Progression-free survival (PFS)
timeFrame: approximately within 36 months
measure: Amount_recovered and Percent_recovered
timeFrame: approximately 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Zhongshan Hospital
state: Shanghai
Study officials:
References: