A PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients
NCT ID: NCT04177290
Last Updated: 2023-02-27
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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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2020-04-02
2022-09-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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sintilimab (M1b) 200mg
Sintilimab (M1b)
Intravenous infusion
sintilimab (approved) 200mg
Sintilimab (approved)
Intravenous infusion
Interventions
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Sintilimab (M1b)
Intravenous infusion
Sintilimab (approved)
Intravenous infusion
Eligibility Criteria
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Inclusion Criteria
2. No EGFR mutation or ALK rearrangement.
3. ECOG PS score 0 or 1.
4. BMI ≥ 21.0kg/m2 and ≤ 26.0kg/m2
5. Body weight ≥ 60.0kg and ≤ 75.0kg.
6. Adequate organ function per protocol-defined criteria.
Exclusion Criteria
2. Allergic to any component of sintilimab.
3. Active autoimmune diseases.
4. Clinically unstable central nervous system metastasis.
18 Years
75 Years
MALE
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, , China
Countries
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Other Identifiers
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CIBI308K101
Identifier Type: -
Identifier Source: org_study_id
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