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

High-risk Non-muscle Invasive Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06108492
• Other study ID #: SHR-2005-I-101
• Status: Recruiting
• Phase: Phase 1
• Start date: November 28, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: December 2023
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: Han Xu
• Phone: 0518-82342973
• Email: Han.xu[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• High-risk Non-muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• SHR-2005
In dose Escalation: Five 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.

Locations

Country	Name	City	State
China	Fudan University Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose limiting toxicities (DLTs)		From Day 1 to Day 21
Primary	Maximum tolerated dose (MTD)		From Day 1 to Day 21
Primary	Incidence and severity of adverse events (AEs) ([CTCAE] v5.0)		From Day 1 to 90 days after last dose
Primary	RP2D(Recommended Phase 2 dose)		From Day 1 to 90 days after last dose
Secondary	PK parameter: Tmax of SHR-2005	Time to maximum concentration of SHR-2005	approximately 24 months
Secondary	PK parameter: Cmax of SHR-2005	Maximum concentration of SHR-2005	approximately 24 months
Secondary	PK parameter: AUC0-8 of SHR-2005	area under the concentration-time curve from time 0 to infinity of SHR-2005	approximately 24 months
Secondary	Immunogenicity of SHR-2005	Anti- SHR-2005 antibody (ADA)	approximately 24 months
Secondary	Duration of response (DoR)	Evaluated using RECIST 1.1	approximately within 36 months
Secondary	Disease control rate (DCR)	Evaluated using RECIST 1.1	approximately within 36 months
Secondary	Progression-free survival (PFS)	Evaluated using RECIST 1.1	approximately within 36 months
Secondary	Amount_recovered and Percent_recovered	The Amount _ recovered and Percent _ recovered of SHR-2005 in urine after intravesical instillation.	approximately 24 months