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

Phase 1

Recruiting

• Conditions: Intermediate and High-risk Non-muscle Invasive Bladder Cancer
• Interventions: Drug: SHR-2005

• Registration Number: NCT06108492
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-31
• Study Start: 2023-11-28
• Status Verified: 2023-12
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03
• Primary Completion: 2026-12-31
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-2005	SHR-2005	Only one arm with SHR-2005

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs) ([CTCAE] v5.0)	From Day 1 to 90 days after last dose
RP2D（Recommended Phase 2 dose）	From Day 1 to 90 days after last dose
Incidence of dose limiting toxicities (DLTs)	From Day 1 to Day 21
Maximum tolerated dose (MTD)	From Day 1 to Day 21

Secondary Outcome Measures

Name	Time	Method
Duration of response (DoR)	approximately within 36 months	Evaluated using RECIST 1.1
PK parameter: AUC0-∞ of SHR-2005	approximately 24 months	area under the concentration-time curve from time 0 to infinity of SHR-2005
Progression-free survival (PFS)	approximately within 36 months	Evaluated using RECIST 1.1
PK parameter: Cmax of SHR-2005	approximately 24 months	Maximum concentration of SHR-2005
Amount_recovered and Percent_recovered	approximately 24 months	The Amount _ recovered and Percent _ recovered of SHR-2005 in urine after intravesical instillation.
Immunogenicity of SHR-2005	approximately 24 months	Anti- SHR-2005 antibody (ADA)
Disease control rate (DCR)	approximately within 36 months	Evaluated using RECIST 1.1
PK parameter: Tmax of SHR-2005	approximately 24 months	Time to maximum concentration of SHR-2005

Trial Locations

Locations (1)

Fudan University Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China