A Phase Ib Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors
NCT ID: NCT05172856
Last Updated: 2021-12-29
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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UNKNOWN
PHASE1
110 participants
INTERVENTIONAL
2022-03-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IBI321 in advanced solid tumors
IBI321
IBI321 at a dose no higher than RP2D, D1 IV Q3W.
Interventions
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IBI321
IBI321 at a dose no higher than RP2D, D1 IV Q3W.
Eligibility Criteria
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Inclusion Criteria
2. Male or female subjects ≥18 years and ≤75 years.
3. At least one measurable lesion per RECIST version 1.1
4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
5. Life expectancy of ≥ 12 weeks.
6. Adequate hematologic and end organ function
Exclusion Criteria
2. Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
3. Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs.
5. Pregnancy, lactation, breastfeeding.
6. Previous exposure to any anti-TIGIT antibody, or recombinant protein.
18 Years
75 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Hunan Cancer Hospital
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Lin Wu
Role: primary
Other Identifiers
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CIBI321A103
Identifier Type: -
Identifier Source: org_study_id