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

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.

Study Overview

• Status: Recruiting
• Conditions: High-risk Non-muscle Invasive Bladder Cancer
• Intervention / Treatment: Drug: SHR-2005

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Han Xu; Phone Number: 0518-82342973; Email: Han.xu@hengrui.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Zhongshan Hospital
      • Contact: Jianming Guo, Doctor; Phone Number: +86-13681971306; Email: Guo.jianming@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-2005; Only one arm with SHR-2005	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of dose limiting toxicities (DLTs)	From Day 1 to Day 21
Maximum tolerated dose (MTD)	From Day 1 to Day 21
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
• Other Study ID Numbers: SHR-2005-I-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No