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

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06108492
• Collaborator: (none)
• Enrollment: 150
• Arm: 1
• Anticipated Duration (Months): 46

Study Details

Study Description

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 high-risk non-muscle invasive bladder cancer.

Condition or Disease	Intervention/Treatment	Phase
High-risk Non-muscle Invasive Bladder Cancer	Drug: SHR-2005	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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 high-risk non-muscle invasive bladder cancer.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
• Anticipated Study Start Date: Nov 30, 2023
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Sep 30, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Incidence of dose limiting toxicities (DLTs) [From Day 1 to Day 21]

2. Maximum tolerated dose (MTD) [From Day 1 to Day 21]

3. Incidence and severity of adverse events (AEs) ([CTCAE] v5.0) [From Day 1 to 90 days after last dose]

4. RP2D（Recommended Phase 2 dose） [From Day 1 to 90 days after last dose]

Secondary Outcome Measures

1. PK parameter: Tmax of SHR-2005 [approximately 24 months]

   Time to maximum concentration of SHR-2005

2. PK parameter: Cmax of SHR-2005 [approximately 24 months]

   Maximum concentration of SHR-2005

3. PK parameter: AUC0-∞ of SHR-2005 [approximately 24 months]

   area under the concentration-time curve from time 0 to infinity of SHR-2005

4. Immunogenicity of SHR-2005 [approximately 24 months]

   Anti- SHR-2005 antibody (ADA)

5. Duration of response (DoR) [approximately within 36 months]

   Evaluated using RECIST 1.1

6. Disease control rate (DCR) [approximately within 36 months]

   Evaluated using RECIST 1.1

7. Progression-free survival (PFS) [approximately within 36 months]

   Evaluated using RECIST 1.1

8. Amount_recovered and Percent_recovered [approximately 24 months]

   The Amount _ recovered and Percent _ recovered of SHR-2005 in urine after intravesical instillation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Hengrui Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT06108492
• Other Study ID Numbers: SHR-2005-I-101
• First Posted: Oct 31, 2023
• Last Update Posted: Oct 31, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Study Results

No Results Posted as of Oct 31, 2023