A Study Evaluating the Safety and Efficacy of IBI188 in Combination With AZA in Subjects With Newly Diagnosed MDS
NCT ID: NCT04511975
Last Updated: 2020-12-21
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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SUSPENDED
PHASE1
32 participants
INTERVENTIONAL
2020-08-24
2022-04-04
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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IBI188 + azacitidine
Participants will receive IBI188 in combination with azacitidine
IBI188
IBI188: 100 mg/mL, intravenous infusion once a week
Azacitidine
Azacitidine (VIDAZA) for Injection:100 mg per vial, subcutaneous injection will be administered for 7 days in each 28 day cycle
Interventions
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IBI188
IBI188: 100 mg/mL, intravenous infusion once a week
Azacitidine
Azacitidine (VIDAZA) for Injection:100 mg per vial, subcutaneous injection will be administered for 7 days in each 28 day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years old.
3. Eastern Cooperative Oncology Group score of 0-2.
4. Adequate organ function.
5. Subjects should take effective contraceptive measures.
6. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.
Exclusion Criteria
2. MDS subjects with lower risk.
3. Subjects who have received chemotherapy.
4. History of chronic hemolytic anemia
5. Prior exposure to any anti-CD47 or anti-SIRPα agents.
6. Subjects participating in another interventional clinical study.
18 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yi Luo
Role: STUDY_DIRECTOR
Innovent Biologics
Locations
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American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
New Jersey Center for Cancer Research
Brick, New Jersey, United States
Gabrail Cancer Center
Canton, Ohio, United States
Countries
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Other Identifiers
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CIBI188A103
Identifier Type: -
Identifier Source: org_study_id