A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours
NCT ID: NCT05804526
Last Updated: 2024-04-30
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/PHASE2
82 participants
INTERVENTIONAL
2023-07-19
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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RC88+Sintilimab Injection
RC88+Sintilimab Injection Arm
RC88
1.5mg/kg ，2.0mg/kg ，2.5mg/kg by intravenous (IV) infusion，every 3 weeks
Sintilimab Injection
Sintilimab 200mg by intravenous (IV) infusion，every 3 weeks
Interventions
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RC88
1.5mg/kg ，2.0mg/kg ，2.5mg/kg by intravenous (IV) infusion，every 3 weeks
Sintilimab Injection
Sintilimab 200mg by intravenous (IV) infusion，every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
3. Predicted survival ≥ 12 weeks
4. Phase I (Phase I) was included and confirmed as MSLN positive (≥1+ after IHC test by central laboratory).Failure, intolerance, or lack of standard treatment has been identified by tissue or cytology The MSLN test is not required for patients with advanced malignant tumor and for subjects diagnosed with malignant mesothelioma;
5. Adequate organ function required
6. Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
Exclusion Criteria
2. Active infection or past hepatitis B or C infection
3. Major surgery less than 1 month before the start of the study
4. Uncontrolled heart disease
5. History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies related compounds
18 Years
70 Years
ALL
No
Sponsors
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RemeGen Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Shi Yuankai, M.D.
Role: STUDY_DIRECTOR
Leading PI
Locations
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National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Yuankai Shi, Ph.D
Role: primary
Other Identifiers
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RC88 C003
Identifier Type: -
Identifier Source: org_study_id
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