A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
NCT ID: NCT06108492
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
170 participants
INTERVENTIONAL
2023-11-28
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SHR-2005
Only one arm with SHR-2005
SHR-2005
In dose Escalation: Four 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.
Interventions
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SHR-2005
In dose Escalation: Four 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Shanghai Hengrui Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR-2005-I-101
Identifier Type: -
Identifier Source: org_study_id